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2.10. Statistical Analysis | SPSS (version 28.0; IBM Corp., Armonk, NY, USA) was used for statistical analyses. The distribution of the data was assessed using the Shapiro–Wilk test, and we confirmed that the data followed a normal distribution. To verify the consistency of baseline values (i.e., values in the second postoperative week), the PRE values were tested between the FR and control groups using an unpaired | PMC9961826 | ||
4. Discussion | postoperative knee pain, postoperative pain, knee flexion ROM, pain, TKA, knee pain | In this study, we investigated the effects of a 1-week comprehensive FR intervention on pain, knee joint ROM, isometric knee extensor muscle strength, walking speed, and balance function from the second to the third postoperative week in patients with TKA. The results showed that adding one week of FR intervention to regular physical therapy significantly improved pain scores at stretching, but there was no synergistic effect on the other parameters.In general, knee pain is known to occur after TKA, and Seo et al. reported that 60% of patients who underwent TKA experienced severe postoperative knee pain, whereas 30% experienced moderate pain [On the other hand, we considered increasing knee joint ROM through FR intervention on the anterior thigh muscles, specifically the knee joint extensors; however, there was no significant interaction between knee flexion ROM in the FR and control groups. Kiyono et al. reported a significant increase in ROM after five weeks of an FR intervention [Both the FR and Control (regular physical therapy only) groups significantly improved 10-m walking speed, TUG time, time to stand on one leg, and isometric knee extensor muscle strength from postoperative weeks two to three. However, there were no significant differences in the changes in these variables between the FR and control groups. A meta-analysis of the effects of the FR intervention on motor function in young subjects reported no change in performance after several weeks of FR intervention training programs [Stretching is a typical postoperative ROM exercise for TKA patients but stretching may also put stress on the wound. Conversely, FR intervention is an approach that can reduce pain by increasing tissue temperature and stimulating proprioceptors without putting stress on the wound. Additionally, FR intervention can approach the quadriceps muscle without putting stress on the wound. Therefore, FR intervention for the quadriceps muscle is used in clinical practice and, as a result, early postoperative knee pain can be suppressed. Early postoperative pain after TKA has been linked to persistent knee pain and reduced walking speed three months post-surgery, suggesting the importance of effective early pain control. Previous research has also found that the severity of pain on postoperative days one and five is associated with improved motor function at three months post-surgery [ | PMC9961826 | |
5. Limitation | pain | There were some limitations in this study. We did not investigate FR intensity. Also, FR intervention is typically not self-administered by patients, and this study has not been blinded. Future research should explore the effectiveness of self-administered FR intervention. In addition, all subjects were taking pain medication during the study period, but the time and dose after using the analgesic medication may vary among participants. Therefore, it is necessary to examine the time and dose after using the analgesic medication under uniform conditions in the future. | PMC9961826 | |
Author Contributions | Conceptualization, M.Y., M.N., A.K. and N.Y.; formal analysis, M.Y. and M.N.; investigation, M.Y., A.I., R.K. and S.W.; methodology, M.Y., M.N., A.K. and N.Y.; supervision, M.N., A.K. and N.Y.; writing—original draft, M.Y., M.N., A.K. and N.Y.; writing—review and editing, M.Y., M.N., A.I., R.K., S.W., A.K. and N.Y. All authors have read and agreed to the published version of the manuscript. | PMC9961826 | ||
Institutional Review Board Statement | This study was approved by the Ethical Review Committee of Takeda General Hospital (approval number: R3-298), and complied with the requirements of the Declaration of Helsinki. | PMC9961826 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC9961826 | ||
Data Availability Statement | All data supporting the conclusions of this study will be fully provided upon request by the authors. | PMC9961826 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC9961826 | ||
References | Flow chart of the study protocol.Foam rolling intervention for anterior thigh, medial thigh, and lateral thigh.Changes in outcome variables before (PRE) and after a 1-week comprehensive foam rolling (FR) program (POST).Data are presented as mean ± standard deviation. Δ Change = Amount of change from PRE to POST. * | PMC9961826 | ||
Methods | psychopathic traits | We revised a previously validated game of prosocial behavior by including a new trial type (i.e., trials where the participant will lose money and the charity will gain money). This version of the game was administered online and participants were randomized to group (exposed to a control stimulus video or a video used to elicit moral elevation, i.e. a positive response to witnessing another’s act of kindness). We used repeated game administration to test whether a moral elevation stimulus affected game behavior and moderated the negative association between psychopathic traits and prosocial behavior. | PMC10115303 | |
Results | Prosocial behavior on the new trial types added in this revised game correlated strongly with prosocial behavior on the old trial type (i.e., trials where the participant will gain money and the charity will lose money; | PMC10115303 | ||
Conclusions | psychopathic traits, psychopathic | Choices on this revised game of prosocial behavior, which can be administered online, are associated with psychopathic traits scores. The game appears to have high immediate test-retest reliability. Exposure to the moral elevation stimulus did not affect prosocial behavior or impact the relationship between psychopathic trait scores and prosocial behavior. Future research should continue to test potential moderators of this relationship. Limitations of the current study are discussed. | PMC10115303 | |
Data Availability | Administered | Sakai, J., Chintaluru, Y., Raymond, K. M., McWilliams, S., Carter, R. M., Winters, D. E., & Mikulich, S. (2022, January 8). A Revised Prosocial Behavior Game Administered Online: Testing Associations with Psychopathic Traits and the Effects of a Moral Elevation Stimulus on Game Behavior. | PMC10115303 | |
1. Introduction | psychopathic traits | Prosocial behavior, “behavior which the actor expects will benefit the person or persons to whom it is directed” [Prior studies have utilized multiple approaches to measure prosocial behavior. These include self-report, categorical measures (e.g., offered the opportunity to volunteer or donate–with outcomes being yes/no), economic games, which generally involve interactions between two or more participants [While declining Trial Type A has generally been considered a prosocial act in prior papers [There has been increasing interest in studying approaches to enhancement of prosocial behavior. Prosocial behavior has been associated with emotional well-being, life satisfaction and happiness [In addition, we further sought to test the hypothesis that exposure to a moral elevation stimulus, at least in part, moderates the negative relationship between psychopathic traits and prosocial behavior in comparison to exposure to a neutral stimulus. Individuals with high levels of callousness and psychopathic traits have a blunted self-reported moral elevation response [ | PMC10115303 | |
2. Materials and methods | The Colorado Multiple Institutions Review Board (COMIRB #17–0182) approved the study protocol and the study protocol was registered with ClinicalTrials.gov (NCT03834467). | PMC10115303 | ||
2.1 Recruitment, randomization and study procedures | Subjects (n = 500) were recruited via advertising on Craigslist (some subjects contacted the study team via review of the ClinicalTrials.gov database), were assessed for meeting the study age requirement (18–25 years; note we sought to recruit a general population sample of young adults and therefore had minimal inclusion/exclusion criteria) and consented to study participation. The study statistician created a within-sex permuted blocks randomization scheme to assign subjects to Group (moral elevation vs. Control Stimulus video) that was implemented in REDCap [ | PMC10115303 | ||
Consort flow diagram. | PMC10115303 | |||
Comparisons of subject characteristics by study group. | CROSS | Mean (standard deviation) or Count (%). For testing, race was collapsed into 3 categories: white, non-white, and other/no answer. MW = Mann-Whitney U test; LSRPS = Levenson Self Report Psychopathy Scale; RCVAS = Red Cross Visual Analog Score (0–100, higher scores indicate a more positive view of the Red Cross). | PMC10115303 | |
2.2 AlAn’s short game version 2 | CROSS | The AlAn’s short game version 2 is programmed in REDCap. Subjects start with $2.50 and the Red Cross donation starts at $2.50. There are three trial types in the game. (1) | PMC10115303 | |
2.3 Elevation stimulus and control videos | Subjects were randomized to either view a moral elevation stimulus video (Group 1; available here ( | PMC10115303 | ||
2.4 Levenson Self Report Psychopathy Scale (LSRPS) | impulsive aggression, psychopathic | Prior to watching the assigned video, subjects completed the LSRPS, a self-report 26-item questionnaire, which provides a two-factor measure of psychopathic traits. We examined Factor 1 score (callousness; derived from 16 questions, range of scores 16–64), Factor 2 score (impulsive aggression; derived from 10 questions, range of scores 10–40) and Total score (sum of Factor 1 and 2 scores). This self-report measure has been previously validated in general [ | PMC10115303 | |
2.5 Data analyses and study hypotheses | Using estimates from our prior work (standard deviation = 6.3) [Distributions of outcomes were assessed for approximate normality. Demographic characteristics were compared between Groups using independent t-tests and chi-square tests or their nonparametric equivalents as appropriate. Despite some directional hypotheses, all analyses specified significance level alpha = 0.05 two-tailed. Race was collapsed into 3 categories for inclusion in models as a covariate: white, non-white, and other/multiple/no answer. Sex was denoted as female or not female in models. | PMC10115303 | ||
Examining performance of new trials where the player will lose money and the charity donation will increase | REGRESSION, CROSS | Using data from Run 1 only (prior to moral elevation stimulus vs. control exposure), we tested internal consistency (Kuder-Richardson 20) within and across Active Trial Type and examined the relationship between Active Trial Type A and Active Trial Type B using Pearson correlations initially. Then, a multiple regression of Active Trial Type B on Active Trial Type A for Run 1 estimated their association while adjusting for age, sex, race and Red Cross visual analog scale score. | PMC10115303 | |
Testing for a negative association between psychopathy trait scores and game behavior in Run 1 | psychopathic | REGRESSION, CROSS | We first graphed trial acceptance rates by trial characteristics (i.e., the relative amounts to “You” and the Red Cross) and then examined acceptance rates for those with higher psychopathic trait scores (top 20%; note: this does not represent a clinical cut off but instead was an avenue through which to visualize behavioral patterns in the top quintile). We examined the relationships among prosocial behavior outcomes and psychopathic trait scores with Pearson correlations and then a multiple regression of prosocial behavior on psychopathic trait score, adjusting for age, race, sex and Red Cross visual analog scale score as well as the sex*psychopathic trait interaction if significant. We focused on LSRPS Factor 1 scores as our primary variable of interest in these analyses, in line with our prior work [ | PMC10115303 |
Testing the effects of moral elevation on game behavior | CROSS | We compared Groups over Run using a mixed model analysis of covariance (ANCOVA) adjusting for age, race, and Red Cross visual analog scale score with fixed effects of Group (moral elevation vs. nature video), Run (1 vs. 2), sex (female vs. not female; as well as potential interactions with other fixed effects) and Group by Run interaction and random effect of subject. The two repeated measures on subjects were assumed to have an unstructured covariance structure estimating separate variance for each run and covariance between them thereby circumventing the more restrictive compound symmetric covariance assumption required in repeated measures ANCOVA. Beginning with the 3-way interaction between Group, Run and sex, non-significant higher order interactions ( | PMC10115303 | |
Testing whether type of stimulus (moral elevation vs. Control) moderates the relationship between psychopathic traits and prosocial behavior | psychopathic | CROSS | We hypothesized that the relationship between psychopathic trait score and prosocial behavior would be moderated by the type of video viewed in between Runs. We evaluated the influence of moral elevation video condition exposure in comparison to control video condition, using a mixed model ANCOVA adjusting for age, race, and Red Cross visual analog scale score with fixed effects of Group (moral elevation vs. nature video), Psychopathic trait score (Factor 1), Run (1 vs. 2) and sex, and all their interactions, and random effect of subject with covariance structure as before. Beginning with the 4-way interaction between Group, Psychopathic trait score, Run and sex, non-significant interactions were sequentially removed and the model rerun. The model including three-way interaction (i.e., Group*Psychopathic trait score*Run), as the effect of interest, and all lower order terms was the most parsimonious entertained. | PMC10115303 |
3. Results | PMC10115303 | |||
Examining performance of new trials where player loses money and the charity donation increases | We calculated internal consistency (Kuder-Richardson 20) within Run 1 for Active Trial Type A (0.83), for Active Trial Type B (0.81), and with appropriate reverse scoring of all Active Trial Type B, across Trial Types A and B (0.89). Behavior on the prior version game trials (the number of rejected Active Trial Type A) correlated strongly with newly introduced game trials (number of accepted Active Trial Type B; | PMC10115303 | ||
Testing the effects of moral elevation on game behavior | As shown in | PMC10115303 | ||
Testing for pre-stimulus to post-stimulus change in prosocial behavior among those receiving the moral elevation video stimulus (n = 237) vs. those receiving the Control (nature) video stimulus (n = 248) after adjusting for participant characteristics using a mixed model ANCOVA). | A Group by Run interaction was non-significant ( | PMC10115303 | ||
Testing whether moral elevation moderates the relationship between psychopathic traits and prosocial behavior | psychopathic traits, psychopathy, psychopathic | SENSITIVITY | Analyses examining whether type of stimulus exposure moderated the negative association between psychopathic traits and prosocial behavior were non-significant, indicating that moral elevation exposure did not explain this relationship. In a mixed model ANCOVA evaluating effects of psychopathy, group, Run and sex after adjusting for participant characteristics, all higher order interactions were non-significant and sequentially removed, as described above. The psychopathic trait score by Group by Run interaction was non-significant (Sensitivity analyses removing some participants are reviewed in the Supplemental Materials; results were similar to those from our primary modified intent to treat sample. | PMC10115303 |
4. Discussion | internalizing disorders | CROSS | This revised version of the AlAn’s game provides useful information about self-other considerations and allows mapping of acceptance rates by self-other valuations (see Both Active Trial Type A and new Active trial Type B suggest that on average there is a bias toward over-valuing oneself over the charity. For example, if self-benefit/loss and Red Cross loss/benefit were estimated by subjects to be of equal value, at the ratio = 1 (see Unfortunately, we did not find that moral elevation stimulus exposure led to changes in prosocial behavior. Several prior studies support an effect of moral elevation on prosocial acts [Enhancement of prosocial behavior and understanding the mechanisms which lead to such enhancements is significant. Prosocial behavior is negatively related to both externalizing and internalizing disorders [ | PMC10115303 |
5. Conclusions | prosocial behavior, psychopathic | Behavior on the AlAn’s game v.2 is related to psychopathic trait scores. The game also shows high correlations between runs. Utilizing a randomized, controlled design, we were unable to demonstrate that exposure to a moral elevation stimulus video changes performance on a previously validated game of prosocial behavior (self-other considerations). Further study of the effects of moral elevation on prosocial behavior are merited, along with studies of other potential variables increasing prosocial behavior. | PMC10115303 | |
Supporting information | (DOCX)Click here for additional data file.(DOCX)Click here for additional data file.(PPTX)Click here for additional data file.(DOC)Click here for additional data file. | PMC10115303 | ||
References | PMC10115303 | |||
Background | cardiometabolic diseases | ELEVATED BLOOD PRESSURE, HYPERTENSION | Short sleep duration, defined as < 7 h sleep on weeknights, affects 40% of the US adult population, contributing to the increased risk for cardiometabolic diseases, decreased safety, and poorer mental health. Despite the prevalence of short sleep duration, few studies have tested interventions to extend sleep duration. The objective of this study is to test the effects of a behavioral sleep extension intervention on sleep duration, blood pressure, and other measures of cardiometabolic health among adults with elevated blood pressure or hypertension. | PMC10566182 |
Methods | hypertension | ELEVATED BLOOD PRESSURE, SECONDARY, HYPERTENSION | This is a single-blind, randomized controlled trial to determine the impact of a behavioral sleep extension intervention on sleep duration and cardiometabolic health among individuals with short sleep duration (< 7 h per night) and elevated blood pressure or hypertension (SBP 120–150 mmHg or DBP 80–90 mmHg). After completing the screening, participants will be randomly assigned to either a sleep coaching (intervention) or health education (control) group. The participants will have weekly contact for either coaching or education for 8 weeks (intervention period) followed by monthly coaching or education for the next 2 months (maintenance period). Participants will complete assessment visits, actigraphy, and 24-h ambulatory blood pressure recording at baseline/screening, 8 weeks, and 6 and 12 months. The primary outcome is sleep duration at 8 weeks, and the secondary outcome is blood pressure at 8 weeks. | PMC10566182 |
Discussion | The results of this study will determine the effects of behavioral sleep extension on sleep and cardiometabolic health among adults with short sleep duration and elevated BP/hypertension. The results will inform the feasibility and efficacy of behavioral sleep extension and provide information needed for future multi-site effectiveness studies. | PMC10566182 | ||
Trial registration | ClinicalTrials.gov NCT04766424. Registered on 21 February 2021. | PMC10566182 | ||
Keywords | PMC10566182 | |||
Introduction | PMC10566182 | |||
Background and rationale {6a} | CMD | INSULIN RESISTANCE | According to data from the National Health Interview Survey,70.1 million US adults (29.2%) sleep < 6 h per 24-h period [Despite the well-known negative effects of short sleep duration, surprisingly little attention has been paid to the development of sleep extension interventions and testing whether such treatments can improve CMD. Studies have demonstrated short-term sleep extension results in decreased insulin resistance [ | PMC10566182 |
Objectives {7} | sleepiness, CMD | INFLAMMATION | The goal of this proposed study is to conduct a randomized controlled trial to test the efficacy of our behavioral sleep extension intervention on 24-h ambulatory BP (ABP) and other key biological and behavioral CMD risk factors among participants with short sleep duration and elevated BP/hypertension. The intervention will be completed over a 12-month period in 3 phases, intervention (weeks 0–8), maintenance (months 2–6), and follow-up (months 6–12), allowing us to test the short-term and extended effects of our intervention.Aim 1: To estimate the magnitude of the acute (8 weeks) and extended (12 months) effects of our behavioral sleep extension intervention compared to a health education control group on sleep durationAim 2: To test the effects of our behavioral sleep extension intervention compared with a health education control group on CMD risk factors including 24-h ABP, BMI, body fat, and CMD risk biomarkers (inflammation, glycemic control, lipids)Aim 3: To evaluate the effects of the intervention on key lifestyle behaviors (e.g., diet and physical activity) and patient-reported outcomes (sleep quality, sleepiness quality of life) | PMC10566182 |
Hypotheses | CMD | Compared to the education control group, we predict greater improvements in sleep duration in the intervention group in sleep duration (aim 1), 24-h ABP, and other measures of BP and CMD risk (aim 2) and health behaviors and patient-reported outcomes (aim 3). We predict improvements will persist at the 12-month follow-up, but the effects of the intervention will be attenuated over time. | PMC10566182 | |
Trial design {8} | SECONDARY | This is a single-blind, parallel-group, randomized controlled trial with a 1:1 allocation ratio and superiority framework. The study will test a behavioral sleep extension intervention compared to an education control group. The primary endpoint is 8 weeks and the secondary endpoint is 12 months. A CONSORT-style flow chart for the trial is shown in Fig. CONSORT-style flow chart for the trial | PMC10566182 | |
Methods: participants, interventions, and outcomes | PMC10566182 | |||
Study setting {9} | hypertension | HYPERTENSION | This study will recruit participants with elevated BP/stage I hypertension and sleep duration < 7 h from community settings in Salt Lake City, Utah, and the surrounding area. | PMC10566182 |
Participant timeline {13} | BLOOD | The schedule of time points, study assessments, and interventions is listed in Fig. Schedule of time points, study assessments, and interventionsAfter web or telephone screening, participants will complete a baseline/screening visit. Participants will undergo standardized BP screening to determine BP eligibility. The BP screening protocol involves 3 unattended BP recordings taken with an automated BP machine (HEM-907HL, OMRON Healthcare Inc.) after a 5-m quiet resting period and 3 m between measurements. If they meet the study criteria, they will review the consent form with the study staff and complete the informed consent prior to continuing the study visit. Participants will complete self-reported questionnaires and cognitive testing and then will wear the study devices at home over the next 10 days (Apnea link monitor for 1 night, ambulatory blood pressure monitor (OnTrak Ambulatory Blood Pressure Monitor 90,227, Spacelabs Inc.) for 24 h, and actigraphy and physical activity monitor for 10 nights). At the end of the baseline period, participants will return to the lab to download their devices and will have their blood drawn. If eligible for the study, they will be randomized to either the sleep extension intervention group or the education control group. They will receive a study letter and materials in the mail, as well as a call from the study coach informing them of their group assignment. The study interventions have 3 main periods. In the intervention period (study weeks 1–8), participants will receive 8-weekly intervention or control sessions and content. In the maintenance period (months 2–6), participants will receive monthly intervention or control sessions and materials. Finally, in months 6–12, participants will be observed, but there will be no interventions delivered. | PMC10566182 | |
Eligibility criteria {10} | cognitive or neurological disorders, comorbid sleep disorders, schizophrenia,, dementia, apnea, bipolar disorder, overnight obstructive sleep, alcohol abuse, insomnia, cancer, renal disease, depressive symptoms, Parkinson’s, hypertension, weight loss | OBSTRUCTIVE SLEEP APNEA, RESTLESS LEGS SYNDROME, HYPERTENSION, DISORDERS | The following are the inclusion criteria:Age 18–65 years.In-office BP readings indicating elevated BP/stage I/II hypertension (SBP of 120–150 mmHg or DBP of 80–90 mmHg). Note that participants taking antihypertensive medications will be permitted if stable dose for > 8 weeks and willing to maintain their dose for the 8-week intervention period.Time in bed < 8 h and habitual sleep duration < 7 h via actigraphy at baseline/screening.Smartphone user.Able to read/write English.The following are the exclusion criteria:High risk or presence of moderate to severe comorbid sleep disorders (i.e., obstructive sleep apnea, restless legs syndrome, or insomnia) as assessed by the questionnaires and overnight obstructive sleep apnea at the baseline/screeningResistant hypertension, defined as currently taking > 4 antihypertensive medications or 3 medications and standardized in lab BP > 130 mmHg SBP or 80 mmHg DBP at screeningHistory of cognitive or neurological disorders (e.g., dementia, Parkinson’s, multiple sclerosis)Arm circumference > 50 cmPresence of major psychiatric disorders (e.g., schizophrenia, bipolar disorder), alcohol abuse on screening questionnaire (women > 7 drinks per week and more than 4 drinks on one occasion; men > 14 drinks in 1 week and more than 5 on one occasion), drug use on the NIDA-Modified ASSIST (score > 3), and moderate to severe depressive symptoms (PHQ-8 > 9)Unstable or serious medical illness that would interfere with participation (cancer, renal disease on dialysis)Overnight work of more than 1 × per monthUse of hypnotic or stimulant medicationsSituations that would significantly impact the ability to extend sleep, including overnight caregiving responsibility for children under the age 1 and elderly or disabled adults > 1 × per weekInability to read or write in EnglishPregnancy/desire to become pregnant during the study periodCurrently following weight loss program, bariatric surgery in the past year, or current use of weight loss medications | PMC10566182 |
Who will take informed consent? {26a} | Participants will attend a screening visit, and prior to consent, the research staff will take their resting blood pressure using a standardized protocol. Participants who are eligible based on their blood pressure readings will complete informed consent. Consent will be completed by the trained study staff (the research coordinator or research assistant) during an in-person visit to the University of Utah. The informed consent document will be reviewed with participants after a standardized blood pressure reading to determine preliminary eligibility. | PMC10566182 | ||
Additional consent provisions for collection and use of participant data and biological specimens {26b} | This study includes blood draws for cardiometabolic risk markers (e.g., lipids, glycated hemoglobin (HbA1c)) as well as Alzheimer’s-related biomarkers (targeted metabolomics, lipidomics) and the genetic risk gene apolipoprotein E4 testing (APOE4). In the consent process, participants will have the opportunity to opt out of blood draws, opt out of genetic testing, and the option to opt out of receiving results of genetic testing. | PMC10566182 | ||
Interventions | PMC10566182 | |||
Intervention description {11a} | TED | The behavioral sleep extension intervention consists of a wearable sleep tracker, a weekly educational email, and one weekly phone call from a coach. The maintenance intervention consists of monthly email and phone calls.Self-monitoring (wearable sleep tracker): Participants receive a Fitbit wearable sleep tracker to allow them to monitor their sleep and discuss the results with the coach. Participants and the coach will have access to the sleep tracker data through a dashboard on the Fitabase platform. Participants will be instructed to enter their sleep goals into the sleep tracker app.Education: Participants will receive weekly educational content via email. Topics include the importance of sleep for health (e.g., what is healthy sleep?), regulation of sleep and circadian rhythms, and strategies to avoid bedtime procrastination. The weekly educational content consists of written and video didactic content (e.g., TED talks). Email was selected for the delivery mode to promote engagement, as its use is already integrated into the lives of most people, and it is accessible across platforms (e.g., smartphones, desktops, or tablets). Educational content (Fig. Motivational enhancement (telephone coaching): The weekly telephone coaching sessions are used to set goals related to the participant’s sleep, increase commitment to these goals, and problem-solve barriers to achieving the goals. The main behavioral goal is increasing time in bed. The first coaching session will be a 20-min engagement session, which includes introductions, rationale for the program, clarifying the role of the coach, reviewing the participants’ baseline sleep data, setting goals for the program for both sleep and daytime function, and reinforcing the participants’ commitment to change their behavior. In the following coaching sessions, the coach and participant will have a brief (5–10 min weekly) follow-up call to review the progress, boost self-efficacy, problem-solve barriers to progress, and set goals for the following week. During the maintenance period (months 2–6), the calls will be scheduled monthly. In between sessions, the coaches will be available, mostly over email, to troubleshoot any problems with the educational material or sleep tracker. The coaching protocol is based on the principles of Supportive Accountability and uses techniques drawn from cognitive behavioral therapy and motivational interviewing, such as goal setting and developing discrepancies between current and desired behaviors. A list of the intervention and coaching session content is listed in Table Educational contentIntervention content and coaching | PMC10566182 | |
Control group description | Participants assigned to the health education control group will be provided with weekly health education emails with content written at < 4th grade level. Participants in this group will also receive brief weekly scripted telephone calls from the coach (< 5 min) to determine if they received the health information and if they had any questions about the materials. Coaches will not provide sleep counseling or goal setting but may clarify terms or concepts. Participants in the control group will be instructed to maintain their current sleep schedule and will not be monitored with sleep diaries, a technique previously reported to produce little change in sleep timing over 4 weeks. | PMC10566182 | ||
Measures of intervention fidelity | All coaching sessions will be recorded for training and fidelity monitoring. All coaches will be trained until they reach a criterion of adherence to the treatment protocol before being assigned study participants. In each quarter, Dr. Duffecy (co-PI) will review approximately 10 sessions quarterly in year 1 and 10 sessions yearly in subsequent years and code them for adherence using previously developed rating scales [ | PMC10566182 | ||
Criteria for discontinuing or modifying allocated interventions {11b} | injury or major change | Participants may be removed from the study if the participant requests withdrawal or the principal investigators consider it necessary to stop the intervention (e.g., significant change that would significantly affect study participations such as pregnancy or a critical injury or major change in health, beginning a shift work job). In this case, the participant would be discontinued from the study, including stopping receiving their emails and coaching sessions. They would receive compensation for study tasks completed up to that point and would not be invited to complete further follow-up assessments. Any information and data collected will be analyzed with the rest of the data. | PMC10566182 | |
Strategies to improve adherence to interventions {11c} | HOLIDAY | Retention during the intervention and maintenance periods will be handled by the coaches (e.g., coach will attempt to contact participants via their preferred contact method and reschedule missed sessions when possible). The study staff will also send quarterly study newsletters and birthday and holiday cards to participants throughout the study. | PMC10566182 | |
Relevant concomitant care permitted or prohibited during the trial {11d) | hypertension | HYPERTENSION | For the intervention period (weeks 1–8), we will use a constrained usual care model (requesting participants to keep antihypertensive medications constant if possible) to reduce non-study-related variability in the acute intervention phase. For the maintenance and no intervention periods (months 2–12), we will track the medication changes at study assessments but will not require participants to remain at a consistent dose. This plan is based upon current hypertension guidelines that allow for lifestyle interventions for 3–6 months in elevated/stage I hypertension. Both groups will receive written instructions reminding them to follow up as recommended with primary care. | PMC10566182 |
Provisions for post-trial care {30} | This trial does not include provisions for post-trial care. If participants inquire about additional sleep interventions after the trial, they will be provided with information about local sleep centers. | PMC10566182 | ||
Outcomes {12} | sleepiness, sleep disturbance, sleep-related impairment | SECONDARY | Study outcomes and assessment time points are listed in Fig. Primary outcome: The primary outcome is a change in sleep duration from baseline to 8 weeks. Sleep duration at baseline and 8 weeks will each be calculated as averages over 10-day periods. Sleep duration will be measured by 8–10 days of actigraphy at baseline/screening, week 8, and 6 and 12 months with the Actiwatch Spectrum device (Philips Respironics Inc.). Devices will be configured using default settings and scored using the Acitware Software (Philips Respironics, Inc.). Actigraphy will be manually scored using a standardized procedure [Main secondary outcome: The main secondary outcome will be change in 24-h SBP from baseline to 8 weeks. This measure will be calculated as an average for the 24-h period at baseline and 8 weeks. BP will be assessed by 24-h ABPM at home using the Spacelabs ambulatory BP monitor (Spacelabs Healthcare, Hertford, UK). Participants will wear the BP monitor at baseline/screening, week 8, and 6 and 12 months. Monitors will be programmed to take readings in random 20-min intervals during the day and 30-min intervals at night.Other secondary outcomes: Changes from baseline to 6 months and from baseline to 12 months will be measured to evaluate the maintenance of sleep duration changes. In addition, changes in 24-h SBP from baseline to 6 and 12 months will be measured to evaluate the maintenance. We will also measure the change in 24-h diastolic blood pressure (DBP) from baseline to 8 weeks and 6 and 12 months. We will measure diet quality by administering the Automated Self-Administered 24-h Dietary Assessment Tool and calculating the Healthy Eating Index (HEI-2018) [Objective 24-h physical activity data including sedentary behavior will be collected using the ActivPAL4 activity monitor [Other measures of cardiometabolic risk will be measured at screening, week 8, and months 6 and 12 including BMI and body fat estimation using a bioimpedance scale (Tanita of America), waist and hip circumference, lipids, and HbA1c. We will also evaluate the effects on nocturnal and diurnal BP and on non-dipping BP status defined by ABPM levels as mean nighttime to daytime SBP/DBP ratio of > 0.90.Participants will complete measures of patient-reported outcomes at session baseline, week 8, and months 3, 6, 9, and 12, including the PROMIS sleep disturbance, sleep-related impairment and sleepiness [We will assess the intervention acceptability and user engagement to inform our findings and plan for future studies (Fitbit usage, coaching session attendance and duration, and email lesson engagement and use surveys and open-ended questions at the end of the intervention and follow-up periods). | PMC10566182 |
Participant timeline {13} | A description of the participant timeline is listed in Fig. A description of the participant timeline | PMC10566182 | ||
Sample size {14} | Our power calculations are based on the assumption that the standard deviation (SD) for change in sleep duration from baseline to 8 weeks will not exceed 37.4 min, which is 10% higher than the SD for change in sleep duration of 34 min reported after 40 days in our previous study [If we also assume that (1) the SD for baseline SBP will be | PMC10566182 | ||
Recruitment {15} | EVENTS, RECRUITMENT | The study will use both active and passive recruitment methods. For active recruitment, patients from the University of Utah Health (UU Health) primary care practices who meet the initial criteria (age, BP) will be sent letters explaining the study and providing information for online screening. The study staff will follow-up letters with a phone call and email to potential participants. We will work with local community leaders and community health workers to enhance the recruitment of diverse study participants, such as providing flyers and information about the study to share with their communities. We will attend local health fairs and conduct BP screening and share study information for interested participants. For passive methods, we will post flyers on the University of Utah campus and nearby areas (e.g., grocery stores and coffee houses) and will post ads on social media (e.g., Facebook). If recruitment slowdowns happen, the team could send more letters, expand to a larger number of clinics, post more frequently on social media, consider in-person recruitment in primary care visits, and attend more health fair events. | PMC10566182 | |
Assignment of interventions: allocation | PMC10566182 | |||
Sequence generation {16a} | Randomization will be performed using random permuted blocks with stratification by sex and antihypertensive medication use. | PMC10566182 | ||
Concealment mechanism {16b} | The randomization allocation will be completed by the biostatistician and loaded into the REDCap system, where it will be concealed from the study investigators and staff. | PMC10566182 | ||
Implementation {16c} | After the screening is completed, the study staff will enter data into a REDCap form including the inclusion/exclusion criteria and stratification information. The interventionist only will have access to the randomization module in REDCap and will complete the randomization and notify the participant of his or her assignment. | PMC10566182 | ||
Assignment of interventions: blinding | PMC10566182 | |||
Who will be blinded {17a} | The study staff, the PI, and the co-Is who are not directly responsible for delivering the intervention will be blinded. Participants and the interventionist will be unblinded. The interventionist will not be involved in the collection of outcome measures. The statistician, who creates the randomization table and is completing the analyses will also be unblinded. | PMC10566182 | ||
Procedure for unblinding if needed {17b} | ADVERSE EVENTS | The study has appointed an independent safety monitor, a primary care physician, who is unaffiliated with the study and is available to review the adverse events. He will be unblinded if necessary and will recommend to the study team if a situation arises that unblinding is critical to addressing the situation. | PMC10566182 | |
Data collection and management | PMC10566182 | |||
Plans for assessment and collection of outcomes {18a} | PMC10566182 | |||
Screening measures | sleep disorders, restless legs, insomnia, Insomnia, depressive symptoms | RESTLESS LEGS, RESTLESS LEGS | Participants will complete self-report measures to evaluate for the presence of elevated depressive symptoms and symptoms of common sleep disorders on the web/phone prescreening. Participants who demonstrate elevated depressive symptoms (score ≥ 15) on the PHQ-8, moderate severity of restless legs (score ≥ 11) on the International Restless Legs Working Group Questionnaire, or severe insomnia on the Insomnia Severity Index [ | PMC10566182 |
Outcome measures | inflammation, sleep disturbance, sleep-related impairment | INFLAMMATION, SECONDARY | Primary outcome: Sleep duration at 8 weeks. Sleep will be measured by 8–10 days of actigraphy at baseline/screening, week 8, and 6 and 12 months with the Actiwatch Spectrum device (Philips Respironics Inc.). Devices will be configured using default settings and scored using the Acitware Software (Philips Respironics, Inc.). Actigraphy will be manually scored using a standardized procedure [Main secondary outcome: 24-h SBP at 8 weeks. We will use the validated (AAMI criteria) SpaceLabs 90,207 monitor which is generally considered the “gold standard” for ABPM [Dietary intake will be collected using the ASA-24, an online automated 24-h dietary recall system [Objective 24-h physical activity data including sedentary behavior will be collected using the ActivPAL4 activity monitor [Other measures of cardiometabolic risk will be measured at screening, week 8, and months 6 and 12 including BMI and body fat estimation using a bioimpedance scale (Tanita of America, Arlington Heights, IL), waist and hip circumference, inflammation (IL-6, CRP), lipids, and HbA1c. Training procedures for body measurements include 1:1 training and practice with Dr. Baron and sign off when the staff member can demonstrate following procedures. We will also evaluate the effects on nocturnal and diurnal BP and on non-dipping BP status defined by ABPM levels as mean nighttime to daytime SBP/DBP ratio of > 0.90 [Participants will complete measures of patient-reported outcomes at session baseline, week 8, and months 3, 6, 9, and 12, including the PROMIS sleep disturbance and sleep-related impairment [We will assess intervention acceptability and user engagement to inform our findings and plan for future studies (Fitbit usage, coaching session attendance and duration, and email lesson engagement and use surveys and open-ended questions at the end of the intervention and follow-up periods).Data collection forms are not posted publicly but will be made available upon request. | PMC10566182 |
Plans to promote participant retention and complete follow-up {18b} | Retention for the assessment visits will be handled by the study staff. During informed consent, the staff will discuss with the participants the differences between intervention and assessment as well as the impact of dropout on the validity of study results, while also highlighting voluntary participation. For participants who drop out of the intervention (defined as nonattendance of the coaching or health education calls from that point to the end of the intervention period), we will continue to attempt to obtain outcome assessments. We will respond with empathy and attempt to collect primary outcomes if the full assessment is not feasible. Monetary incentives include payment for each study component and a $40 bonus for the completion of all sleep and ABPM time points. | PMC10566182 | ||
Data management {19} | SLEEP APNEA | This study will use the secure, web-based Research Electronic Data Capture (REDCap) for data input. Case report forms will be designed to flag out-of-range values. When possible, participants will enter data directly into REDCap. For forms that need to be manually entered (e.g., blood test results, sleep apnea screening), data will be double-checked to verify accuracy. Intervention and control sessions will be stored on Box, a HIPAA-compliant file storage platform. Access to the study data will be limited to the investigators and staff with official roles relevant to the study data. | PMC10566182 | |
Confidentiality {27} | All investigators and staff will have up-to-date certification on confidentiality and privacy throughout the Collaborative Institutional Training Initiative (CITI) and will have completed additional HIPAA training through The University of Utah. Physical documents will be kept in folders within locked file cabinets in a locked office. Digital documents will be kept on a HIPAA-compliant Box drive or within REDCap. After the trial, data will be kept for 7 years following the last publication of the data. Names and other identifiable information will not be associated with study data. Participants will be assigned a screening ID number and when enrolled into the study, an individual trial ID number. | PMC10566182 | ||
Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} | Alzheimer’s disease | We will collect and store serum for targeted metabolomics analyses to evaluate whether changes in sleep affect biomarkers related to Alzheimer’s disease risk. | PMC10566182 | |
Statistical methods | PMC10566182 | |||
Statistical methods for primary and secondary outcomes {20a} | REGRESSION, SECONDARY | The primary outcome of the proposed study is the change in the mean sleep duration from baseline to 8 weeks. The study sample size has been determined based on the primary analysis of covariance (ANCOVA) that will compare mean sleep duration at 8 weeks, with statistical adjustment for the baseline sleep duration and the sex and age randomization strata. The proposed ANCOVA approach is recommended for the evaluation of treatment effects on continuous outcomes in randomized trials because it optimally accounts for random imbalances in the outcome at baseline and regression to the mean, thus providing superior statistical power compared to the analyses of change scores or follow-up scores without adjustment for baseline levels [The main secondary outcome for this study is the change in SBP from baseline to 8 weeks. Evaluation of the 24-h SBP outcome at 8 weeks will assure that few patients will have modified their antihypertensive medication regimen over the 8-week interval prior to the primary outcome assessment.Evaluation of the 24-h SBP outcome at 8 weeks will assure that few patients will have modified their antihypertensive medication regimen over the 8-week interval prior to the primary outcome assessment. Similar ANCOVA models as used with sleep duration will also be used to evaluate the acute effects on this and other numeric secondary and tertiary outcomes.We will use linear mixed models [ | PMC10566182 | |
Interim analyses {21b} | There are no interim analyses planned for this study. | PMC10566182 | ||
Methods for additional analyses (e.g., subgroup analyses) {20b} | mild obstructive sleep apnea | OBSTRUCTIVE SLEEP APNEA, EVENTS | In addition to our primary analyses, we plan to analyze the results of participants who completed the intervention per protocol, in that they attended all the coaching or health education sessions. We will also conduct exploratory analyses based on clinically significant improvements in sleep and analyze the results among participants in the intervention group that extended their sleep duration by at least 30 min and for those who met criteria at 8 weeks of having sleep duration over 7 h. Finally, we plan to test the impact of obstructive sleep apnea as a moderator of sleep and cardiometabolic outcomes. We will conduct moderator analyses of participants to test the results of the intervention among participants with mild obstructive sleep apnea (5–15 apneas per hour at screening) compared to those with < 5 events per hour. | PMC10566182 |
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c} | We plan to apply multiple imputation to impute missing outcome data, using comprehensive imputation models that include both non-missing measurements from the variables included in the data analysis as well as additional auxiliary variables that are considered to be predictive either of the risk of missingness or the values of the variables whose missing values are being imputed. The multiple imputation approach has been established as superior to alternatives, including complete case analysis or simplified ad hoc single imputation approaches [ | PMC10566182 | ||
Plans to give access to the full protocol, participant-level data, and statistical code {31c} | De-identified data and a codebook will be provided upon written request to the contact PI (Dr. Baron). | PMC10566182 | ||
Oversight and monitoring | PMC10566182 | |||
Composition of the coordinating centre and trial steering committee {5d} | RECRUITMENT | This study does not have a coordinating centre or trial steering committee. Dr. Baron and Dr. Duffecy (co-PIs) are jointly responsible for the conduct of the study. Dr. Baron is the contact PI and is responsible for the day-to-day study operations, overseeing the local study staff who are conducting recruiting and data collection activities and responsible for communications with NIH. Dr. Duffecy is responsible for the coaching component of the study, including overseeing the training of the study coach and conducting fidelity assessments of the intervention and control groups. The executive team will meet monthly and is led by Dr. Baron and includes Dr. Duffecy and the co-PIs as well as the project coordinator and staff. The study operations team, including Drs. Baron, Duffecy, the biostatistician (Dr. Allen), study coordinator, and research assistant, will meet weekly to review the study progress and proactively address any potential issues or slowdowns. The data management team (led by Randy Madsen) consists of the University of Utah Biomedical Informatics Core (BMIC), the statistician (Dr. Allen), and co-I/senior statistician, Dr. Greene. This team provides administration and technical staff to support the development of case report forms in REDCap, as well as automated prompt, reminders, randomization modules, and overseeing blinding in the study database. The recruitment and data collection will be conducted by the study coordinator and research assistant. Their day-to-day activities will be supervised by Dr. Baron, who is on site at the research office. There is not a formal stakeholder and public involvement group in this trial. | PMC10566182 | |
Composition of the data monitoring committee, its role, and reporting structure {21a} | ADVERSE EVENTS | Due to the low-risk nature of the study, there is no data monitoring committee. The study team has appointed an independent safety monitor to review any potential adverse events during the study. | PMC10566182 | |
Adverse event reporting and harms {22} | ADVERSE EVENTS, ADVERSE EVENT, EVENTS | Given the non-invasive nature of the intervention, no new adverse events are expected. Adverse events will be assessed at each study visit and between visits if reported during the study period. Adverse events will be reported according to the standard procedures. The team will review such events and rate them as | PMC10566182 | |
Frequency and plans for auditing trial conduct {23} | The study investigators will submit an annual report to the study sponsor (National Institute of Nursing) including details of enrollment in the past year, progress on the study aims, and any barriers to completing the study. The study progress will be reviewed by NIH via the yearly progress report. The team will also submit a yearly report to the University of Utah Institutional Review Board (IRB). The team will internally audit the study records yearly throughout the trial period. | PMC10566182 | ||
Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25} | Plans for protocol modifications will first be approved by the sponsor (NIH). Then, any modifications will be approved by the IRB and updated in ClinicalTrials.gov. Participants will be notified of the protocol changes, if applicable, at their next study visit, where they will complete an updated informed consent form if necessary. Any protocol deviations will be documented in the protocol deviation form and reported to the IRB. | PMC10566182 | ||
Dissemination plans {31a} | The study team will share updates to the participants approximately quarterly and will send a result summary at the end of the study. The results of the study will be presented at international conferences and publications in peer-reviewed journals. The team will work with their institutions and use social media to highlight the presentations and publications from this study. | PMC10566182 | ||
Discussion | hypertension, insomnia, cardiometabolic disease | HYPERTENSION | This study aims to test the effects of a real-world behavioral sleep extension intervention on sleep and cardiometabolic health among adults with elevated BP/stage I/II hypertension and short sleep duration. Despite the effectiveness of other behavioral sleep medicine treatments, such as cognitive behavioral therapy for insomnia (CBT-I) [The main feature of our intervention is the use of coaching combined with wearable technology to motivate behavior change. In our previous research, the use of consumer sleep technology was rated as highly desirable to individuals with short sleep duration and, in our intervention development, was rated as the most enjoyable aspect of the study [An important limitation to note is that this intervention focuses on extending sleep among individuals who are able to extend their sleep opportunity. We acknowledge that the causes of short sleep duration are multifactorial, and only some aspects are modifiable. Particularly relevant to communities of color, longstanding structural barriers affect sleep contributing to disparities cardiometabolic disease risk [In summary, the results of this study will demonstrate the short-term (8 weeks) and longer-term (12 months) effects of behavioral sleep extension. Future research is needed to study in other populations, biopsychosocial contributors to individual differences in who can and cannot extend sleep and also to understand interventions geared toward maintenance of behavior change. | PMC10566182 |
Trial status | RECRUITMENT | Protocol ver 1.0 (date 06/28/23).Recruitment began: 3/15/2021.Anticipated recruitment completion date: 1/1/2024. | PMC10566182 | |
Acknowledgements | The authors thank Max Byck for assistance in drafting this manuscript. | PMC10566182 | ||
Authors’ contributions {31b} | TG | All authors have read and approved of this manuscript. KB and JD are co-PI for this study and jointly conceived the study and designed the protocol and study-related processes. KB is the contact PI and is primarily responsible for daily study operations. JD is primarily responsible for the execution of the coaching intervention, coach training, and fidelity monitoring. SS, AB, MC, TG, CA were involved in conception of the study, protocol design and reviewing the manuscript. SV was involved in study design and drafted portions of the initial draft. | PMC10566182 | |
Funding {4} | The research reported in this publication was supported (in part or in full) by the National Institute on Nursing and the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number(s) 1R01HL141706-01A1, 3R01NR018891-01A1S1, UL1TR002538, UM1TR004409, 5R01HL139837-04, 5R01AG074989-02, 5R01AG065805-04 and 1K24AG080168-01. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. | PMC10566182 | ||
Availability of data and materials {29} | De-identified data and a study codebook will be made available at the end of the study upon request to the contact PI (KB). | PMC10566182 | ||
Declarations | PMC10566182 | |||
Ethics approval and consent to participate {24} | This study was approved by the University of Utah Institutional Review Board (IRB_00130332), and written informed consent will be obtained from all participants. | PMC10566182 | ||
Consent for publication {32} | Not applicable, no identifiable images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. Informed consent materials are attached as supplementary materials. | PMC10566182 |
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