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Qualitative phase
We designed a new label which is a combination of the traffic light, warning (The PACE label was first designed by Swartz et al. (In one study, a warning label was assessed for certain products that were high in sugar, sodium, and saturated fats (The findings of our study were concordant with the studies in which envir...
PMC10683755
Quantitative phase
TLL
The PACE label failed to influence food choices in terms of caloric content. The lowest calories of the foods selected were seen in the TLL + brochure group in the pairwise comparison of the intervention vs. control group. The calories of the selected foods in the TLL+ brochure were 76 kcal less than the control; howev...
PMC10683755
Policy implications
Based on our findings, it seems that traffic light labels, when accompanied by a brochure, can lead consumers toward food choices with fewer calories.
PMC10683755
Limitations
TLL, ’d
BLIND
Certain inevitable limitations always exist in qualitative studies, and must be considered when interpreting the findings. Usually, mothers are responsible for the purchase of foodstuff in Iranian households. Therefore, we chose to only interview the schoolchildren’s mothers, and not their fathers, who may have held en...
PMC10683755
Conclusion
The new label presented in this study is a combination of the physical activity, traffic light symbols, and warning labels. According to the mothers in the qualitative phase, the new label helped them make lower caloric choices, even in those with the lowest level of nutritional knowledge. In the quantitative phase, we...
PMC10683755
Data availability statement
The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.
PMC10683755
Ethics statement
The studies involving humans were approved by Research Ethics Committee of Tehran University of Medical Sciences (96-03-161-37037). The studies were conducted in accordance with the local legislation and institutional requirements. The participants provided their written informed consent to participate in this study.
PMC10683755
Author contributions
AD
SS: Conceptualization, Formal analysis, Investigation, Methodology, Project administration, Writing – original draft, Writing – review & editing. SN: Data curation, Formal analysis, Writing – review & editing. ES: Project administration, Writing – review & editing. AD: Project administration, Writing – review & editing...
PMC10683755
Abbreviations
DISEASES
ANOVA, analysis of variance; BMI, body mass index; COREQ, consolidated criteria for reporting research; CONSORT, consolidated standards of reporting trials flow diagram; FGDs, focus group discussions; Kcal, kilo calorie; PhD, doctor of philosophy; PACE, physical activity calorie equivalent; NCD, non-communicable diseas...
PMC10683755
Conflict of interest
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
PMC10683755
Publisher’s note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ...
PMC10683755
Supplementary material
The Supplementary material for this article can be found online at: Click here for additional data file.Click here for additional data file.Click here for additional data file.Click here for additional data file.
PMC10683755
References
PMC10683755
Introduction
deaths
COMPLICATIONS
The Sustainable Development Goal-3 aimed to scale down the maternal mortality ratio to below 70 deaths per one hundred thousand live births by 2030 [Institutional delivery is one of the key tools to ensure safe delivery under trained medical practitioners and tackle any delivery-related complications efficiently reduci...
PMC10529544
Objectives of the study
SECONDARY
The primary objective of this study is to determine the effect of e-registration and mHealth on institutional deliveries in the hazard-prone areas of Southern Bangladesh. The secondary objectives are to determine the prevalence of institutional deliveries, different modes of institutional deliveries, and the birth outc...
PMC10529544
Hypothesis
We hypothesize that e-registration and mHealth will increase institutional deliveries in the hazard-prone areas of Southern Bangladesh.
PMC10529544
Materials and methods
We used the SPIRIT checklist when writing this manuscript and the standard protocol items are shown in
PMC10529544
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist.
PMC10529544
Study design and setting
The study will be an open-label two-arm non-randomized controlled cluster trial for six months where Chandpur Sadar, Kachua, and Faridganj sub-districts will be the intervention arm as MIS unit; DGFP will initiate the eMIS registration system in these three sub-districts of Chandpur district. Chandpur is a district und...
PMC10529544
Registration
This experiment is also registered in the open science framework (registration number: DOI
PMC10529544
Recruitment of the participants
The FWAs register all the pregnant mothers of their respective unions in the traditional paper-based system. We will digitalize an e-registration system in the intervention areas and in the control areas we will continue the paper-based register. The Family Planning Inspectors (FPI) then collate the data and a complete...
PMC10529544
Flow diagram of pregnant mothers enrolment from FWA register.
The inclusion and exclusion criteria of the participants are given in the following:
PMC10529544
Inclusion criteria
Pregnant mothers registered in the paper-based FWA register,Age group 19–45 years,Residence of—Intervention group: Chandpur Sadar, Faridganj, or Kachua sub-districts of Chandpur District, and Control group: Bhola Sadar, Charfesson, or Lalmohan sub-districts of Bhola District,Gestational period of 28–36 weeks,Have acces...
PMC10529544
Exclusion criteria
COMPLICATIONS
Pregnant mothers with severe pregnancy-related complications at the baseline,Pregnant mothers who will develop severe pregnancy-related complications, migrate out, lost to follow-up, or die during the study period,Mothers who will deliver beyond 42 weeks of their gestational period,Pregnant mothers who will refuse to p...
PMC10529544
Sample size
We have planned to recruit and then follow up a minimum of 268 pregnant mothers in the intervention areas and 268 pregnant mothers in the control areas. According to a study conducted in Ethiopia, the implementation of mHealth services using both voice calls and text messages increased facility delivery by 14.7% in the...
PMC10529544
Conceptual framework of data collection process.
sepsis, eclampsia
ECLAMPSIA, COVID-19 INFECTION, ANTEPARTUM HEMORRHAGE, SEPSIS, COMPLICATIONS
The questionnaire is subdivided into three main sections–screening measure, baseline survey, and end-line survey. During the baseline period, we will screen pregnant mothers using the screening tools. The screening tools will include mothers who will give consent and exclude pregnant mothers with severe pregnancy-relat...
PMC10529544
Intervention
PMC10529544
e-registration and mHealth
In the intervention areas, the pregnant mothers will be registered in the FWA e-Register database so that they can be tracked and their schedules can be maintained electronically. The FWAs will visit the pregnant mothers’ homes of their designated unions and register them in the eMIS database using an android tablet co...
PMC10529544
Outcome measures
PMC10529544
Primary outcome
Institutional deliveryNormal vaginal deliveries, cesarean sections and assisted vaginal deliveries (forceps and vacuum deliveries) conducted at any healthcare facility by a medically trained provider/ skilled birth attendant situated at the study sites will be considered as institutional delivery.Indicator: Proportion ...
PMC10529544
Secondary outcome
Mode of deliveryIndicator: Proportion of normal vaginal deliveries  Proportion of cesarean sections  Proportion of forceps and vacuum deliveriesDenominator: Total deliveries2. Birth outcomeIndicator: Proportion of live births  Proportion of stillbirthsDenominator: Total births
PMC10529544
Data management and analysis plan
REGRESSION
We will analyze the data in R 4.1.2. We will do a frequency distribution and proportion analysis for categorical variables, and for continuous variables, we will perform a mean and standard deviation analysis. We will use chi-square test to make comparison between the groups. Finally, a random-intercept mixed-effect lo...
PMC10529544
Quality control and quality assurance
MINOR
We do not anticipate any major deviation from the protocol such as any harm to the participant, or enrollment of participants not eligible for the study. Minor deviations like lost to follow-up will be addressed by enrolling an adequate sample size taking into consideration at an attrition level of 5%. We will communic...
PMC10529544
Ethics approval
Ethical approval has been taken from the Ethical Review Board of North South University (Ref: 2022/0R-NSU/IRB/0205) (
PMC10529544
Patient and public involvement statement
We will not involve patients and the public during the study design development phase.
PMC10529544
Discussion
COMPLICATIONS
This two-arm non-randomized controlled cluster trial of six months will determine the effect of e-registration tracking and mHealth counseling as a complete package on institutional deliveries in the hazard-prone areas of Southern Bangladesh. A minimum of 268 pregnant mothers of 28–36 weeks will be enrolled and followe...
PMC10529544
Supporting information
PMC10529544
Ethical approval.
(PDF)Click here for additional data file.
PMC10529544
Complete protocol submitted to the ethical approval board.
(PDF)Click here for additional data file.
PMC10529544
SPIRIT checklist.
(PDF)Click here for additional data file.
PMC10529544
List of abbreviations
CORONAVIRUS
Antenatal care19: Coronavirus Disease-2019Directorate General of Family PlanningFamily Welfare AssistantMillennium Development GoalMaternal Mortality RatioSustainable Development Goal
PMC10529544
References
PMC10529544
Key Points
PMC10080376
Question
T2D, type 2 diabetes, MCI, cognitive impairment
TYPE 2 DIABETES
Is tai chi chuan as a mind-body exercise intervention more effective than fitness walking for improving cognitive function for older adults with type 2 diabetes (T2D) and mild cognitive impairment (MCI)?
PMC10080376
Findings
T2D, MCI
In this randomized clinical trial including 328 adults 60 years or older with T2D and MCI, tai chi chuan showed significantly more benefit on global cognitive function at 36 weeks compared with fitness walking. There was no significant difference between the 2 exercise groups at 24 weeks.
PMC10080376
Meaning
T2D, MCI, cognitive impairment
TYPE 2 DIABETES
These findings suggest that mindfulness tai chi chuan may be an effective cognitive treatment option for older adults with T2D and MCI.This randomized clinical trial explores the effectiveness of tai chi chuan in improving cognitive function of older adults with type 2 diabetes and mild cognitive impairment (MCI) compa...
PMC10080376
Importance
Type 2 diabetes, T2D, cognitive impairment, MCI, cognitive dysfunction
TYPE 2 DIABETES
Type 2 diabetes (T2D) is associated with the progression of cognitive dysfunction. Physical activity benefits cognition, but no evidence from randomized clinical trials has shown whether tai chi chuan has better long-term benefits than fitness walking in cognitive function for patients with T2D and mild cognitive impai...
PMC10080376
Objective
T2D, MCI
To compare the effectiveness of tai chi chuan, a mind-body exercise, for improving cognitive function in older adults with T2D and MCI, with fitness walking.
PMC10080376
Design, Setting, and Participants
T2D, MCI
This randomized clinical trial was conducted between June 1, 2020, and February 28, 2022, at 4 sites in China. Participants included 328 adults (aged ≥60 years) with a clinical diagnosis of T2D and MCI.
PMC10080376
Interventions
diabetes
DIABETES
Participants were randomized in a 1:1:1 ratio to a tai chi chuan group, a fitness walking group, or a control group. The tai chi chuan group received 24-form simplified tai chi chuan. The fitness walking group received fitness walking training. Both exercise groups took the training for 60 min/session, 3 times/wk, for ...
PMC10080376
Main Outcomes and Measures
The primary outcome was the global cognitive function measured at 36 weeks by the Montreal Cognitive Assessment (MoCA). Secondary outcomes included MoCA at 24 weeks and other cognitive subdomain measures and blood metabolic indices at 24 and 36 weeks.
PMC10080376
Results
T2D
A total of 328 participants (mean [SD] age, 67.55 [5.02] years; mean [SD] T2D duration, 10.48 [6.81] years; 167 [50.9%] women) were randomized to the tai chi chuan group (n = 107), fitness walking group (n = 110), or control group (n = 111) and included in the intention-to-treat analysis. At 36 weeks, the tai chi chuan...
PMC10080376
Conclusions and Relevance
T2D, MCI
In this randomized clinical trial including older adults with T2D and MCI, tai chi chuan was more effective than fitness walking in improving global cognitive function. The findings support a long-term benefit, suggesting the potential clinical use of tai chi chuan as an exercise intervention to improve cognitive funct...
PMC10080376
Trial Registration
ClinicalTrials.gov Identifier:
PMC10080376
Introduction
Type 2 diabetes, T2D, MCI, cognitive dysfunction
TYPE 2 DIABETES
Type 2 diabetes (T2D) and cognitive dysfunction are highly prevalent and frequently coexist in older adults.Exercise is an essential component of the management programs advised for patients with T2D.Therefore, we designed a randomized clinical trial to explore the effectiveness of tai chi chuan in improving cognitive ...
PMC10080376
Methods
PMC10080376
Study Design
This multicenter randomized clinical trial had 3 parallel groups and was conducted at 4 sites in China (Fuzhou, Harbin, Shenzhen, and Beijing). The trial protocol and statistical analysis plan are available in
PMC10080376
Participants
dementia, T2D, MCI, cognitive impairment
The study included community-dwelling adults from 4 sites. Enrollment began June 1, 2020, and ended February 28, 2022. Inclusion criteria were (1) a clinical diagnosis of T2D, (2) the presence of MCI without dementia, (3) 60 years or older, (4) no engagement in regular exercise in the last 3 months, and (5) informed co...
PMC10080376
Randomization and Masking
Research Electronic Data Capture (REDCap) data set system was used to randomly assign participants to the tai chi chuan, fitness walking, or control groups in a 1:1:1 ratio (
PMC10080376
Study Flowchart
ITT indicates intention to treat; MITT, modified ITT; and PP, per-protocol.
PMC10080376
Interventions
T2D, musculoskeletal, sensory, and cognitive systems
COMPLICATIONS
All groups participated in education seminars related to T2D management, including proper diet, blood glucose level monitoring, and prevention of complications, given by clinical endocrinologists for 0.5 hours each time, once every 4 weeks for 24 weeks. Participants who were assigned to the control group did not receiv...
PMC10080376
Measurements and Outcomes
All participants were assessed at baseline and at 24 and 36 weeks. Assessments were conducted in accordance with a uniform implementation plan and standard operating procedures.
PMC10080376
Primary Outcomes
The primary outcome was global cognition assessed at 36 weeks. The Montreal Cognitive Assessment (MoCA)
PMC10080376
Secondary Outcomes
Secondary outcomes included MoCA assessment at 24 weeks and other cognitive subdomain tests and blood metabolic indices measured at 24 and 36 weeks. Cognitive subdomain tests included the Wechsler Memory Quotient (MQ), Digit Symbol Substitution Test (DSST), Trail-Making Test, part B (TMT-B), Boston Naming Test (BNT), a...
PMC10080376
Statistical Analysis
Based on a previous studyAll the participants were included in the intention-to-treat (ITT) analysis. Modified ITT analysis included all randomized participants who completed at least 12 weeks of the intervention. Per-protocol analysis included participants who adhered to the treatment protocol. Safety set included the...
PMC10080376
Results
PMC10080376
Participant Characteristics
T2D
RECRUITMENT
A total of 328 participants (mean [SD] age, 67.55 [5.02] years; T2D duration, 10.48 [6.81] years; 161 [49.1%] men and 167 [50.9%] women; all Chinese) were randomized to the tai chi chuan group (n = 107), fitness walking group (n = 110), and control group (n = 111) and included in the ITT analysis. Participant recruitme...
PMC10080376
Baseline Characteristics of Participants
hypertension
CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HYPERTENSION, CORONARY ARTERY DISEASE, DYSLIPIDEMIA
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); DPP-4, dipeptidyl peptidase 4; HbASI conversion factor: To convert fasting glucose to millimoles per liter, multiply by 0.0555. To convert HbAUnless otherwise indicated, data are expressed as No. (%) of particip...
PMC10080376
Primary Outcomes
In the ITT analysis, at 36 weeks, the increase of mean MoCA scores in the tai chi chuan group was significantly more noticeable than in the fitness walking group (24.67 [2.72] vs 23.84 [3.17]; between-group mean difference, 0.84 [95% CI, 0.02-1.66];
PMC10080376
Secondary Outcomes
PMC10080376
Tai Chi Chuan vs Fitness Walking Groups
At 24 weeks, there was no statistical difference in MoCA score improvement between the tai chi chuan and fitness walking groups (
PMC10080376
Tai Chi Chuan vs Control Groups
At 24 weeks, the tai chi chuan group was significantly more effective in improving mean MoCA scores compared with the control group (23.99 [3.10] vs 22.54 [3.29]; between-group mean difference, 1.45 [95% CI, 0.59-2.32]) in ITT analysis (At 36 weeks, compared with the control group, the tai chi chuan group was significa...
PMC10080376
Fitness Walking vs Control Groups
At 24 weeks, the fitness walking group was significantly more effective in improving mean MoCA scores compared with the control group (23.55 [3.34] vs 22.54 [3.29], between-group mean difference, 1.01 [95% CI, 0.15-1.86]) (
PMC10080376
Subgroup Analysis
T2D
Subgroup analysis at 36 weeks showed that tai chi chuan group was significantly more effective in improving MoCA scores compared with fitness walking group in subgroups of women (mean difference, 1.41 [95% CI,0.21-2.61]), body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 24...
PMC10080376
Subgroup Analysis of Montreal Cognitive Assessment (MoCA) at 36 Weeks by Intention-to-Treat (ITT) Analysis
BMI indicates body mass index (calculated as weight in kilograms divided by height in meters squared); HbA
PMC10080376
Adverse Events
Hypoglycemia
ADVERSE EVENTS, EVENTS, HYPOGLYCEMIA
Hypoglycemia events occurred in 1 participant (0.9%) in the tai chi chuan group and in 2 participants (1.8%) in the fitness walking group. Falls were reported in 5 participants (4.7%) in the tai chi chuan group, 10 (9.1%) in the fitness walking group, and 15 (13.5%) in the control group. One participant (0.9%) reported...
PMC10080376
Discussion
T2D, cognitive impairment, cognitive and memory functions, MCI, dementia, diabetes
DIABETES
To our knowledge, this randomized clinical trial is the first to show that tai chi chuan, a mind-body exercise, improved cognitive function for older adults with T2D and MCI compared with fitness walking. Among the participants, the MoCA and MQ scores in the tai chi chuan group were significantly higher than in the fit...
PMC10080376
Strengths and Limitations
This study has important strengths. Compared with the previous study,This study has several limitations. First, the study population was limited by the eligibility criteria used. Second, compared with the control group, participants who were assigned to exercise intervention groups might have anticipated the benefits o...
PMC10080376
Conclusions
T2D, MCI
In this randomized clinical trial including older adults with T2D and MCI, tai chi chuan was found to be more effective than fitness walking at improving global cognitive function. The findings support a long-term benefit of tai chi chuan in strengthening cognitive function, supporting the clinical application of tai c...
PMC10080376
Abstract
colorectal cancer, CKD, chronic kidney disease, CKD‐, lung cancer, prostate, breast, lung, or colorectal cancer, prostate cancer
COLORECTAL CANCER, BREAST CANCER, METASTATIC DISEASE, LUNG CANCER, CHRONIC KIDNEY DISEASE (CKD), CHRONIC KIDNEY DISEASE, PROSTATE CANCER
The objective of this study was to determine the proportion of phase 3 clinical trials investigating a systemic therapy for patients with prostate, breast, lung, or colorectal cancer that excluded patients with Chronic Kidney Disease (CKD) and the exclusion criteria chosen, if any. A search was conducted using the The ...
PMC9939176
AUTHOR CONTRIBUTIONS
PMC9939176
FUNDING INFORMATION
This research did not receive any specific grant from funding agencies in the public, commercial, or not‐for‐profit sectors.
PMC9939176
CONFLICT OF INTEREST
None declared.
PMC9939176
ETHICS APPROVAL
No patient consent was required because the study did not involve patient data. Ethics advice was not required because the data analyzed were public data.
PMC9939176
Supporting information
Table S1 Click here for additional data file. Figure S1 Click here for additional data file.
PMC9939176
REFERENCES
PMC9939176
1. Introduction
Weight loss, overweight or obese PCOS-affected, PCOS, overweight, weight loss
OBESE, POLYCYSTIC OVARY SYNDROME (PCOS), MAY, METABOLIC DISORDERS, POLYCYSTIC OVARY SYNDROME, INSULIN SENSITIVITY
These authors contributed equally to this work.The effects of dulaglutide and a calorie-restricted diet (CRD) on visceral adipose tissue (VAT) and metabolic profiles in polycystic ovary syndrome (PCOS) have not been extensively investigated. In this study, we investigated whether dulaglutide combined with CRD could fur...
PMC9920202
2. Materials and Methods
PMC9920202
2.1. Trial Design and Ethics Statements
MAY
This trial was a randomized, controlled, open-label study conducted in Shanghai Tenth People’s Hospital between May 2021 and May 2022. The study protocol was approved by the Ethics Committee of Shanghai Tenth People’s Hospital (approval number SHSY-IEC-4.1/21-119/01), and the clinical trial registration number was NCT0...
PMC9920202
2.2. Eligibility Criteria
Participants were eligible if they were 18–45 years, had a body mass index (BMI) ≥24 kg/m
PMC9920202
2.3. Randomization and Intervention Programs
weight loss
After a baseline evaluation, participants were randomized to receive dulaglutide combined with CRD or CRD alone, hinged on the predetermined number generated by a computer with a 1:1 allocation, which was concealed using opaque, sealed, and serially numbered envelopes. Participants remained on their prescribed treatmen...
PMC9920202
2.4. Trial Outcomes
weight loss
SECONDARY
The primary outcome was the between-group difference in the change from baseline in the VAT area at the time of achieving 7% weight loss goal. The secondary outcomes included changes in menstrual frequency, blood pressure, metabolic risk factors, reproductive hormones, liver fat content, percentage of total body fat, p...
PMC9920202
2.5. Sample Size Estimation and Statistical Analysis
EVENT, SECONDARY
Based on a previous study [The intention-to-treat principle was applied to all data analysis. Baseline data are presented as means with 95% confidence intervals (CIs) for continuous variables. The median time to event and associated 95% CIs were calculated after the Kaplan–Meier method was applied to analyze time-to-ev...
PMC9920202
3. Results
PMC9920202
3.1. Trial Participants
overweight, weight loss
ADVERSE EVENTS, MAY, OBESE
From May 2021 to May 2022, 243 women were assessed for eligibility. Among them, 175 were excluded considering inclusion/exclusion criteria or other reasons (106 women did not match the criteria for inclusion, 16 women declined to participate, and 53 women were excluded for other reasons). A total of 68 overweight or ob...
PMC9920202
3.2. Baseline Characteristics and Adherence
At baseline, clinical characteristics of subjects were similar between two the groups (
PMC9920202
3.3. Weight Loss
According to the prespecified protocol, participants in both groups lost the same amount of weight. In terms of the absolute amount, the mean weight losses were −5.42 kg (95% CI from −5.79 to −5.05) in the dulaglutide + CRD group and −5.44 kg (95% CI from −5.84 to −5.04) in the CRD group (
PMC9920202
3.4. Body Composition and Fat Distribution
weight loss
After comparable loss in body weight, VAT area at the time of accomplishing the weight loss target was comparably reduced by 18.44 cm
PMC9920202
3.5. Metabolic Risk Factors
weight loss, TG
Although there were significant improvements in glycemic control in both groups, dulaglutide + CRD provided additional benefits with regard to HbA1c and PPG levels as compared with CRD after equivalent weight loss. The groups both showed similar decreases in SBP, DBP, FINS, HOMA-IR, ALT, AST, TC, TG, and LDL-c values. ...
PMC9920202
3.6. Menstrual Frequency and Reproductive Hormones
FAI, weight loss
Although both groups showed an improvement in menstrual frequency, no between-group difference was observed in menstrual frequency from baseline to the time of achieving a 7% weight loss goal. In terms of reproductive hormones, the CRD group showed significant decreases in TT and AD levels, and both groups showed a sim...
PMC9920202