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Ethics approval and consent to participate | This study was approved by the China Ethics Committee of Registering Clinical Trials (Registration number: ChiECRCT20200200) and registered at Clinicaltrials.gov (NCT04477733). The study protocol followed the CONSORT guidelines. The study protocol was performed according to the relevant guidelines. Written informed con... | PMC10044711 | ||
Consent for publication | Not Applicable. | PMC10044711 | ||
Competing interests | The authors declare no competing interests. | PMC10044711 | ||
References | PMC10044711 | |||
1. Introduction | cardiometabolic disease, weight loss, cardiovascular dysfunction | INSULIN RESISTANCE, CARDIOVASCULAR DISEASE, TYPE 2 DIABETES | Timing of nutrient intake for athletes may affect exercise performance and cardiometabolic factors. Our objective was to examine the effect of time-restricted eating (TRE) on cardiometabolic health. Using a cross-over study design, 15 endurance-trained male runners were randomized to either a normal dietary pattern (ND... | PMC9961388 |
2. Materials and Methods | PMC9961388 | |||
2.1. Experimental Design | In this cross-over intervention, subjects were randomly assigned to start the study with either a traditional 12-h eating window (12/12) (ND) or a time-restricted 8-h eating window (16/8) (TRE). Diets were self-selected, and subjects were instructed to consume isocaloric diets of the similar macronutrient composition b... | PMC9961388 | ||
2.2. Subjects | To be included, subjects were required to be born male, have been actively training for the past 3 years, run ≥ 32 km/wk, have competed in a race ≥ 5 km within the last 12 mo, have a maximal oxygen consumption (VO | PMC9961388 | ||
2.3. Familiarization Visit | RECRUITMENT | Following recruitment, subjects visited the USDA, ARS, Western Human Nutrition Research Center (WHNRC) at the University of California at Davis campus to learn the study parameters and receive instruction using in-house equipment. After signing the informed consent, subjects then completed a health history questionnair... | PMC9961388 | |
2.4. Test Day Protocol | Four research test days were scheduled with one at the beginning and end of each of the 4-week periods. Subjects arrived following an overnight fast and were asked to only drink water. They had been instructed to refrain from exercise for 24 h, follow a consistent hydration pattern, and consume the same meal the night ... | PMC9961388 | ||
2.5. Resting Energy Expenditure | Subjects rested for 10 min in a supine position in a dark, quiet room. Respiratory gases were then collected for 20 min. Data from the first 5 min were excluded from analysis to account for subject adjustment to the protocol. The Weir equation was used to determine rate of kcal/day (Equation (1)). Because nitrogen excr... | PMC9961388 | ||
2.6. Blood Pressure | orthostatic tolerance | Immediately after the REE determination and before standing, resting blood pressure (BP) was measured manually with a single-hosed sphygmomanometer and stethoscope by the same investigator for all trials. After supine blood pressure was measured, subjects were asked to stand for 5 min before collecting standing blood p... | PMC9961388 | |
2.7. Body Composition | A whole-body dual-energy X-ray absorptiometry (DXA) (Hologic Discovery QDR Series 94994; Hologic, Inc.) scan was performed for determination of body composition. The DXA scanner was calibrated prior to each use by the same trained and licensed technician. The scan provided values for total fat mass, total lean mass, bo... | PMC9961388 | ||
2.8. Blood Analyses | STERILE, BLOOD | Fasting blood samples were collected using sterile, disposable materials by a licensed phlebotomist. Blood was drawn directly into SST vacutainers. SST tubes sat at room temperature for 30 min and were then centrifuged in a refrigerated Centra CL3R (International Equipment Co.) for 10 min at 100× Insulin was measured i... | PMC9961388 | |
2.9. Statistical Analysis | Johnson transformation | All analyses were done using JMP Pro 14 (SAS Institute Inc, Cary, NC, USA). For each variable, the change from pre- to post-intervention was calculated, and the effects of diet intervention, sequence and interaction were analyzed using a mixed linear model. All variables that were not considered normally distributed we... | PMC9961388 | |
3. Results | PMC9961388 | |||
3.2. Resting Energy Expenditure | After 4 weeks, there was no significant difference between the TRE and ND interventions for resting energy expenditure, resting respiratory exchange ratio, resting energy expenditure by body mass and resting energy expenditure by fat-free mass ( | PMC9961388 | ||
3.3. Body Mass and Composition | We have previously reported [ | PMC9961388 | ||
3.4. Bone Mineral Density | DXA results for bone mineral density and bone mineral density z-score can be found in | PMC9961388 | ||
3.5. Insulin Resistance and Sensitivity | Fasting blood glucose and insulin concentrations were not different between interventions and are shown in | PMC9961388 | ||
3.6. Blood Pressure | No significant differences were observed for systolic or diastolic blood pressure in the supine position or after 5 min of standing between diet interventions ( | PMC9961388 | ||
3.7. Circulating Lipids and Lipoproteins | No differences in total cholesterol and triglycerides, as well as VLDL-, LDL-, HDL- or non-HDL-cholesterol (nHDLc), were detected between diet interventions ( | PMC9961388 | ||
4. Discussion | overweight, cardiovascular disease | OBESE, INSULIN RESISTANCE, CARDIOVASCULAR DISEASE | This report extends the original findings from our TRE study in endurance-trained athletes [The present study is one of just a few studies to investigate the effects of the 16/8 time-restricted eating diet in trained athletes. To our knowledge, there is only one other study conducted in endurance-trained athletes. Brad... | PMC9961388 |
5. Conclusions | caloric deficit diet | EVENT | These results suggest that endurance athletes adhering to an isocaloric 16/8 TRE dietary pattern for 4 weeks experienced no identifiable adverse changes in the cardiometabolic risk factors. Athletes who are trying to reduce fat mass before an event should consider adopting a TRE dietary pattern as opposed to a caloric ... | PMC9961388 |
Author Contributions | Conceptualization: C.E.R., A.P.T., N.L.K., M.D.V.L. and G.A.C.; Methodology: A.P.T., C.E.R., N.L.K., M.D.V.L., B.A.D. and G.A.C.; Formal analysis: A.P.T. and C.E.R.; Investigation: A.P.T., C.E.R., N.L.K., B.A.D. and G.A.C.; Writing—initial draft: C.E.R.; Reviewing and editing: A.P.T., C.E.R., N.L.K., M.D.V.L., B.A.D. a... | PMC9961388 | ||
Institutional Review Board Statement | MAY | The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of the University of California Davis, IRB protocol number 1223350 (24 May 2018). Informed consent was obtained from all participants prior to enrolling in the study. | PMC9961388 | |
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC9961388 | ||
Data Availability Statement | The data presented in this study are available on request from the corresponding author. The data are not publicly available due to privacy concerns. | PMC9961388 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC9961388 | ||
Objective | Evidence shows that dialogic book-sharing improves language development in young children in low-middle income countries (LMICs), particularly receptive and expressive language. It is unclear whether this intervention also boosts development of other neurocognitive and socio-emotional domains in children. Using a rando... | PMC10728827 | ||
Methods | 122 Caregivers and their children (mean age 3.5 years) were randomly assigned to an intervention group ( | PMC10728827 | ||
Results | No differences were observed between intervention and control groups on receptive and expressive language, or any of the neurocognitive or socio-emotional measures from baseline (3.5 years) to 4 months post-intervention administration (4 years). | PMC10728827 | ||
Keywords | PMC10728827 | |||
Introduction | EVENTS | Dialogic book-sharing (DBS) is a parenting reading method used to stimulate reciprocal interactions between young children and their caregivers [As book-sharing can draw focus to various themes and explore the meaning of events [The aim of the present study was to examine the neurocognitive and socio-emotional effects ... | PMC10728827 | |
Methods | PMC10728827 | |||
Study design | We conducted a randomized controlled trial (RCT) to evaluate a dialogic book-sharing intervention for parents or caregivers of children aged 3.5 years. This RCT was retrospectively registered with the Pan African Clinical Trials Registry on 03/04/2022 (PACTR202204697674974). This RCT was nested in the Drakenstein Child... | PMC10728827 | ||
Study setting | trauma | HIV INFECTION | The DCHS recruited participants from two peri-urban relatively stable, low socioeconomic communities (Mbekweni and Paarl East). The former is predominantly an isiXhosa speaking community, and the latter, an Afrikaans speaking community. These communities experience a high prevalence of substance use, exposure to trauma... | PMC10728827 |
Sample selection and size | miscarriage | MISCARRIAGE, RECRUITMENT | Pregnant women were recruited from two primary health care clinics for the main DCHS study. Mothers were enrolled at 20 to 28 weeks' gestation while attending routine antenatal care and were prospectively followed. Women were eligible for the study if they were 18 years or older, between 20 and 28 weeks gestation, plan... | PMC10728827 |
Measures | All measures were administered in the child's home language as all measures were translated into Afrikaans and isiXhosa. | PMC10728827 | ||
Language | Receptive and expressive language was measured using the Peabody Picture Vocabulary Test, fourth edition (PPVT-4) [ | PMC10728827 | ||
Selective attention | visual inattention | The Balloon Hunt Task is a paper-and-pencil task from TEA-Ch2 J (5–7 years) designed to evaluate visual inattention [ | PMC10728827 | |
Executive function | CARD | Working memory was assessed using the Picture Memory task from the Wechsler Preschool and Primary Scale of Intelligence, fourth edition (WPPSI-IV) [The Dimensional Change Card Sort (DCCS) [The adapted Stroop-like day-night task assesses the child's ability to inhibit an automatic response. In the control trials, the ch... | PMC10728827 | |
Social cognition | Theory of Mind was examined using Diverse Desires and Diverse Beliefs tasks from the early and basic modules of the UCT Theory of Mind battery [ | PMC10728827 | ||
Internalizing and externalizing behavior | The Child Behavior Checklist (CBCL for children aged 1.5–5 years) [ | PMC10728827 | ||
Procedures | PMC10728827 | |||
Study procedures | Consecutive children attending the standard 3.5-year psychosocial assessment of the DCHS were recruited by DCHS fieldworkers for the book-sharing intervention. After enrolment, block randomization to an intervention or control group which was completed off-site. Post-randomization confirmation was obtained that the gen... | PMC10728827 | ||
Randomization and blinding | This parallel intervention used permuted block randomization. Group allocation was determined by the holder of the sequence who was situated off-site. Participants were allocated to the intervention group ( | PMC10728827 | ||
Intervention program | The intervention commenced in April 2018 and ran to completion in December 2019. The book-sharing program is a group-based parenting intervention based on previous programs implemented and investigated in similar settings in South Africa [Weekly themes of intervention sessions with accompanying books.Denotes books with... | PMC10728827 | ||
Data analysis | REGRESSION | Intervention and control groups were first compared on social, maternal and child factors at baseline to assess efficacy of the randomization method in producing equivalent groups, using means and standard deviations for continuous variables and frequencies with corresponding percentages for categorical variables. Chi-... | PMC10728827 | |
Results | PMC10728827 | |||
Discussion | non-language neurocognitive | Book-sharing was no more effective than normal development in the waiting list control on receptive and expressive language, as well as neurocognitive and socio-emotional measures, at post-intervention. Both groups improved, as expected, with age when comparing test scores 6 months later.Contrary to individual studies ... | PMC10728827 | |
Conclusions | neurocognitive and socio-emotional differences | In children aged 3.5 years in a LMIC country setting, dialogic book-sharing did not improve language proficiency (receptive and expressive language), or neurocognitive and socio-emotional gains at 4 months post-intervention. Possible reasons for these findings include that there may be a critical period in which to imp... | PMC10728827 | |
Trial registration | This trial was retrospectively registered on the Pan African Clinical Trial Registry on 03/04/2022; PACTR202204697674974. | PMC10728827 | ||
Ethics approval and consent to participate | Specific approval was obtained for the Book-sharing RCT protocol (543/2017) from the Faculty of Health Sciences, Human Research Ethics Committee, University of Cape Town. Mothers provided informed consent at enrolment and yearly after that. Informed consent was obtained for all participants in their preferred language:... | PMC10728827 | ||
Competing interests | The intervention was conceptualized by PC and DJS, with guidance from LM and HJZ. All other authors declare no conflicts of interest. | PMC10728827 | ||
Declaration of interest | DJS and HJZ are funded by the South African Medical Research Council (SAMRC). | PMC10728827 | ||
Funding | The RCT was conducted with no additional funding beyond what the DCHS already received. Support for the DCHS was provided by the | PMC10728827 | ||
References | PMC10728827 | |||
Data availability | The Drakenstein Child Health Study is committed to the principle of data sharing. De-identified data will be made available to requesting researchers as appropriate. Requests for collaborations to undertake data analysis are welcome. More information can be found on our website [ | PMC10728827 | ||
Acknowledgements | We thank the mothers and their children for participating in the study and the study staff, the clinical and administrative staff of the Western Cape Government Health Department at Paarl Hospital and at the clinics for support of the study. The Mikhulu Trust ( | PMC10728827 | ||
Key Points | PMC10690460 | |||
Question | Is skin-to-skin contact (SSC) between parents and their very preterm infants immediately after birth more effective than standard incubator care in enhancing mother-infant interaction at 4 months? | PMC10690460 | ||
Findings | SECONDARY | In this secondary analysis of a randomized clinical trial including video recordings of 71 mother–very preterm infant dyads in interaction during free play, SSC provided by a parent during the first 6 hours after birth significantly enhanced child interactive behaviors and positive affect at 4 months. | PMC10690460 | |
Meaning | SECONDARY | These findings suggest that alongside necessary nursing and medical care, clinical practices should support the mother-infant relationship by promoting immediate SSC with a parent after birth.This secondary analysis of the IPISTOSS randomized clinical trial examines the effect of immediate skin-to-skin contact at birth... | PMC10690460 | |
Importance | Good-quality parent-infant interactions have protective effects on infant socio-emotional and behavioral development. These interactions are especially critical for very preterm infants at risk of vulnerabilities related to immaturity. Skin-to-skin contact (SSC) has been found to improve mother–preterm infant interacti... | PMC10690460 | ||
Objective | To determine the effect of immediate SSC at birth for very preterm infants on mother-infant interaction quality at 4 months of corrected age. | PMC10690460 | ||
Design, Setting, and Participants | SECONDARY | This secondary analysis used data from the Immediate Parent-Infant Skin-to-Skin Study (IPISTOSS), a randomized clinical trial conducted between April 1, 2018, and June 30, 2021, at 3 neonatal units in Sweden and Norway. Participants included very preterm infants (28-33 gestational weeks of age) and their parents. Four-... | PMC10690460 | |
Intervention | Infants were allocated to standard incubator care or SSC with either parent initiated at birth and continued throughout the first 6 hours after birth. | PMC10690460 | ||
Main Outcomes and Measures | REGRESSION | The primary outcome was mother-infant interaction quality as measured with the Parent–Child Early Relational Assessment (PCERA), based on video recordings of a 5-minute free-play situation with mother-infant dyads at 4 months of corrected age. A multilevel regression analysis was performed. | PMC10690460 | |
Results | This analysis included 71 infants (31 twins [44%]) and 56 mothers. Infants had a mean (SD) gestational age of 31 weeks 3 (1.3) days, and more than half were male (42 [59%]); mothers had a mean (SD) age of 32 (4.9) years. There were 37 infants allocated to standard care and 34 to SSC with either parent after birth. Duri... | PMC10690460 | ||
Conclusions and Relevance | PRETERM BIRTH | In this study of the effect of immediate parent-infant SSC after very preterm birth, SSC was beneficial for the mother-infant relationship. These findings suggest that immediate SSC should be supported in the clinical setting. | PMC10690460 | |
Trial Registration | ClinicalTrials.gov Identifier: | PMC10690460 | ||
Introduction | SECONDARY | Skin-to-skin contact (SSC) is an evidence-based method of care that involves placing the naked infant on the parent’s bare chest. The SSC method is routinely practiced intermittently for preterm infants in the neonatal unit. Because of its multiple benefits, SSC between newborn infants and mothers provided in the immed... | PMC10690460 | |
Methods | PMC10690460 | |||
Study Design | SECONDARY | This secondary analysis reports on a secondary outcome from the Immediate Parent-Infant Skin-to-Skin Study (IPISTOSS), a randomized clinical trial with 2 parallel, nonblinded groups conducted between April 1, 2018, and June 30, 2021. | PMC10690460 | |
Setting and Population | major malformations | CONGENITAL INFECTION, PRETERM LABOR | The IPISTOSS study was conducted at 2 neonatal units at Karolinska University Hospital in Stockholm, Sweden, and at the neonatal unit at Stavanger University Hospital in Stavanger, Norway. Screening was performed for women admitted to obstetric units with threatening preterm labor. This study included inborn infants (s... | PMC10690460 |
Intervention and Procedure | cot | The intervention consisted of SSC between either parent and their very preterm infant (or infants) initiated immediately after birth (SSC group) and continued throughout the first 6 hours after birth and was compared with conventional care in an incubator or cot (control group). Electronic randomization was performed b... | PMC10690460 | |
Intervention | After vaginal birth, SSC was initiated immediately, or as soon as possible, on the mother’s chest, with positioning assisted by the neonatal team. The infant was cared for initially in the birth unit and later transferred to the neonatal unit while maintaining SSC with either parent. After cesarean delivery, SSC was in... | PMC10690460 | ||
Conventional Care | cot | Infants allocated to the control group were stabilized in a warmer (Resuscitaire; GE Healthcare) or in an incubator and then transported to the neonatal unit in an incubator. Intermittent SSC was initiated after the first 6 hours. Parents in the control group were allowed to stay at their infant’s bedside and were able... | PMC10690460 | |
Follow-Up Visit at 4 Months | Depression, ±2 | A follow-up visit was conducted at 4 months (±2 weeks) of corrected infant age in the clinic or at participant homes (in Sweden, 20 visits [57%] were conducted at participant homes due to hospital restriction policies during the COVID-19 pandemic). The visit was made in the morning at a time when the infant preferably ... | PMC10690460 | |
Outcome Assessment | PMC10690460 | |||
Duration of SSC | Duration of SSC (in hours per day) was recorded with the Parent-Infant Closeness Diary | PMC10690460 | ||
Mother-Infant Interaction Quality | Mother-infant interaction quality was assessed with the Parent–Child Early Relational Assessment (PCERA) | PMC10690460 | ||
Statistical Analysis | The IPISTOSS sample size was calculated for the main outcome variable of infant cardiorespiratory stability. | PMC10690460 | ||
Results | PMC10690460 | |||
Study Participants | depression, anxiety | This study included 71 infants (31 twins [44%]) and 56 mothers in the PCERA analysis at 4 months. Infants had a mean (SD) gestational age of 31 weeks 3 (1.3) days and a mean (SD) birthweight of 1535 (408) g; 42 (59%) were boys and 29 (41%) were girls. Mothers had a mean (SD) age of 32 (4.9) years; 32 (57%) were primipa... | PMC10690460 | |
Mother and Infant Characteristics | Depression, Anxiety | Abbreviation: SSC, skin-to-skin contact.Unless indicated otherwise, values are presented as No. (%) of participants.Measured with the Edinburgh Postnatal Depression Scale (score, 0-30).Measured with the Spielberger State-Trait Anxiety Inventory (score, 20-80).Measured with the Swedish Parenthood Stress Questionnaire (s... | PMC10690460 | |
Initiation and Duration of SSC During the Intervention and First 8 Days After Birth | For infants in the SSC group, SSC was initiated at a median (IQR) time of 15 (0-62) minutes after birth. During the intervention period of 0 to 6 hours, the median (IQR) SSC duration was 5.25 (4.5-5.5) hours, and fathers provided more SSC than mothers during this period (3.25 [2.25-4.5] vs 0.75 [0-2.5] hours, respectiv... | PMC10690460 | ||
Duration of SSC During Intervention 0 to 6 Hours After Birth and Accumulated Within First 72 Hours and First 8 Days | Abbreviation: SSC, skin-to-skin contact.In the SSC group, data were missing for 2 mothers, fathers, and infants 7 to 72 hours after birth and for 4 mothers, fathers, and infants 7 hours to 8 days after birth. | PMC10690460 | ||
Mother-Infant Interaction at 4 Months for the SSC and Control Groups, by PCERA Subscale | Abbreviations: PCERA, Parent–Child Early Relational Assessment; SSC, skin-to-skin contact.Unadjusted and adjusted | PMC10690460 | ||
Differences Between the Skin-to-Skin Contact and Control Groups on Parent–Child Early Relational Assessment (PCERA) Subscale 3 (Infant Positive Affect, Communicative and Social Skills) | For each group, the beanplot figure displays the mean (bold horizontal lines), the spread of individual observations (small horizontal lines), and the shape of the distributions. | PMC10690460 | ||
Exploratory Analysis: Accumulated SSC Duration Within 8 Days After Birth and Mother-Infant Interaction at 4 Months | After the intervention, infants’ accumulated time of SSC was higher in the SSC group during the first 72 hours, with a median (IQR) of 17 (10.5-25) vs 10 (5.25-13.5) hours in the control group (Cohen | PMC10690460 | ||
Discussion | immature nervous system, ’ | SECONDARY | This protocol-based secondary analysis of a multicenter randomized clinical trial investigated the effect of immediate SSC with a parent after birth on interaction between very preterm infants and their mother. Our findings support the existence of an early sensitive period for very preterm infants after birth. Infant ... | PMC10690460 |
Strengths and Limitations | This study had several strengths, including its randomized design, which ensured substantially decreased selection bias. The study was well controlled, since only the place of care differed during the intervention. At the 4-month follow-up, 20 (22%) of the originally randomized infants were lost to the PCERA analysis; ... | PMC10690460 | ||
Conclusions | PRETERM BIRTH, SECONDARY | In this secondary analysis of the IPISTOSS randomized clinical trial, SSC practiced between a parent and a very preterm infant in the immediate postpartum period after birth enhanced child interactive behaviors and positive affect at 4 months of corrected infant age. Skin-to-skin contact may also benefit the dyadic asp... | PMC10690460 | |
Methods | In a randomized, cross-over design, 16 (8 females) individuals underwent two sessions of a-tDCS and two sham tDCS (s-tDCS) sessions targeting the left M1 (all participants were right limb dominant), with testing of either the left (ipsilateral) or right (contralateral) quadriceps. Knee extensor (KE) MVC force was recor... | PMC9821721 | ||
Results | There was a significant interaction effect for stimulation condition x leg tested x time [ | PMC9821721 | ||
Conclusion | a-tDCS may be ineffective at increasing maximal force or endurance and instead may be detrimental to quadriceps force production. | PMC9821721 | ||
Data Availability | The datasets generated during and/or analyzed during the current study are publicly available from the Dryad database ( | PMC9821721 | ||
Introduction | fatigue, fatiguability | CORTEX | Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that can induce both excitatory and inhibitory cortical effects depending on the polarity of the stimulation administered [There is conflict in the literature as to whether tDCS can augment muscle strength and endurance perform... | PMC9821721 |
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