Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05703347
Other study ID # 22-019805
Secondary ID 1R01HD108243-01
Status Recruiting
Phase N/A
First received
Last updated
Start date September 21, 2023
Est. completion date June 2027

Study information

Verified date May 2024
Source Children's Hospital of Philadelphia
Contact Jonathan Mitchell, PhD
Phone 2674261473
Email mitchellj2@chop.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The overall objective of this application is to develop a mobile health platform for the pediatric care setting to promote longer sleep duration for childhood obesity prevention.


Description:

Insufficient sleep duration is highly prevalent in childhood and is associated with incident obesity, especially among middle school-aged children. Investigators therefore need to identify strategies to increase sleep duration among children for obesity prevention. The overall objective of this application is to develop a mobile health platform for the pediatric care setting to promote longer sleep duration for childhood obesity prevention. This is a single-site study being conducted at the Children's Hospital of Philadelphia (CHOP). Investigators will randomize 325 children, aged 8-12y, with a body mass index (BMI) between the 50th-95th percentile, and who sleep <8.5 hours per night. Clinical measurements will be acquired at CHOP and sleep will be measured in the home setting. The Way to Health mobile platform will facilitate remote communication and data collection. A validated multi-channel sleep tracker will estimate sleep for 12-months (2-week run-in; 6-month intervention; ≈5.5-month follow-up). A randomized 24 factorial design will assess four components: sleep goal (fixed or modifiable), digital guidance (active or active with virtual study visit), parent incentive (inactive or active), and personalized feedback (inactive or active). The optimal component settings will have to meet the following criteria: increase average baseline sleep duration by ≥30 minutes for ≥75% of intervention weeks and for ≥50% of follow-up weeks. Fat mass will be measured at baseline, 6-, and 12-months using dual energy X-ray absorptiometry (DXA). Total energy intake and the timing and composition of meals will be measured using 24-hour dietary recalls at baseline, 6-, and 12-months. Sociodemographic data will be measured using self-report approaches (e.g., sex, race/ethnicity) and home addresses will be geocoded for geo-spatial analyses.


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date June 2027
Est. primary completion date June 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 12 Years
Eligibility Inclusion Criteria: 1. Aged 8-12 years olds. 2. Insufficient sleep duration (<8.5 hours per night). 3. Body mass index (BMI) between the 50th and 95th percentile for age and sex. 4. One child per family. Exclusion Criteria: 1. Diagnosed with a chronic disease. 2. Diagnosed with a behavioral health problem. 3. Diagnosed with a condition that can impact sleep or growth. 4. Diagnosed with a condition affecting physical growth and maturation or dietary intake. 5. Children with a history of cancer, kidney, GI, musculoskeletal, or sleep disorders. 6. Children who will transition to high-school during the study. 7. Children using steroids/hormones. 8. Children regularly taking medications

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Fixed sleep goal
Investigators will determine if a fixed guideline-based goal (=9 hours per night) is more efficacious for increasing sleep duration.
Personalized sleep goal
Investigators will determine if a personalized goal (=9 hours per night, but can be lowered to a personalized level, capped at +30 minutes per night above baseline) is more efficacious for increasing sleep duration.
Digital sleep health messaging without virtual study visit
All participants will receive digital sleep health messaging. Messaging will focus on evidence-based sleep health recommendations, such as regulating evening electronics use, managing extracurricular activities, and setting consistent bedtime routines and sleep-wake schedules. This group will NOT have virtual psychological visits.
Digital sleep health messaging with virtual study visit
All participants will receive digital sleep health messaging. Messaging will focus on evidence-based sleep health recommendations, such as regulating evening electronics use, managing extracurricular activities, and setting consistent bedtime routines and sleep-wake schedules. The participants will be randomized to additionally receive virtual study visits where doctoral-level psychology trainees will be trained to implement evidence-based behavioral sleep health guidance.
Inactive Parent-Directed Loss-Framed Incentive
No parental incentive
Active Parent-Directed Loss-Framed Incentive
Parents will receive a financial incentive when their child achieves their sleep goal. The incentive will be loss-framed; parents will receive an endowment of $10 at the start of each intervention week, in a virtual bank account; Investigators will deduct $2 each weeknight the sleep duration goal is not met; the funds remaining in the virtual account will be dispensed each Sunday. The weekly endowment-payment approach allows for fresh starts each week. The incentive will be directed at parents as a method to enhance engagement. Investigators will ask parents at baseline and at the end of each month to rate their perceived support in helping their child to meet their sleep duration goal.
Inactive Supportive Feedback
No supportive feedback
Active Supportive Feedback
Participants will receive a weekly performance summary message each Sunday during the intervention period, with supportive feedback included to motivate children to maintain their good performance in the week ahead, or to try and improve upon a weak or moderate performance in the week ahead. Investigators will ask children will complete an online survey each Sunday to measure how motivated they are to achieve their sleep goal in the week ahead.

Locations

Country Name City State
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
Children's Hospital of Philadelphia Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (26)

Allen SL, Howlett MD, Coulombe JA, Corkum PV. ABCs of SLEEPING: A review of the evidence behind pediatric sleep practice recommendations. Sleep Med Rev. 2016 Oct;29:1-14. doi: 10.1016/j.smrv.2015.08.006. Epub 2015 Sep 1. — View Citation

Cespedes Feliciano EM, Rifas-Shiman SL, Quante M, Redline S, Oken E, Taveras EM. Chronotype, Social Jet Lag, and Cardiometabolic Risk Factors in Early Adolescence. JAMA Pediatr. 2019 Nov 1;173(11):1049-1057. doi: 10.1001/jamapediatrics.2019.3089. — View Citation

Chinoy ED, Cuellar JA, Huwa KE, Jameson JT, Watson CH, Bessman SC, Hirsch DA, Cooper AD, Drummond SPA, Markwald RR. Performance of seven consumer sleep-tracking devices compared with polysomnography. Sleep. 2021 May 14;44(5):zsaa291. doi: 10.1093/sleep/zsaa291. — View Citation

Corkum P, Lingley-Pottie P, Davidson F, McGrath P, Chambers CT, Mullane J, Laredo S, Woodford K, Weiss SK. Better Nights/Better Days-Distance Intervention for Insomnia in School-Aged Children With/Without ADHD: A Randomized Controlled Trial. J Pediatr Psychol. 2016 Jul;41(6):701-13. doi: 10.1093/jpepsy/jsw031. Epub 2016 May 16. — View Citation

Daniels SR, Hassink SG; COMMITTEE ON NUTRITION. The Role of the Pediatrician in Primary Prevention of Obesity. Pediatrics. 2015 Jul;136(1):e275-92. doi: 10.1542/peds.2015-1558. Epub 2015 Jun 29. — View Citation

de Zambotti M, Baker FC, Willoughby AR, Godino JG, Wing D, Patrick K, Colrain IM. Measures of sleep and cardiac functioning during sleep using a multi-sensory commercially-available wristband in adolescents. Physiol Behav. 2016 May 1;158:143-9. doi: 10.1016/j.physbeh.2016.03.006. Epub 2016 Mar 9. — View Citation

Forrest CB, Meltzer LJ, Marcus CL, de la Motte A, Kratchman A, Buysse DJ, Pilkonis PA, Becker BD, Bevans KB. Development and validation of the PROMIS Pediatric Sleep Disturbance and Sleep-Related Impairment item banks. Sleep. 2018 Jun 1;41(6). doi: 10.1093/sleep/zsy054. — View Citation

Godino JG, Wing D, de Zambotti M, Baker FC, Bagot K, Inkelis S, Pautz C, Higgins M, Nichols J, Brumback T, Chevance G, Colrain IM, Patrick K, Tapert SF. Performance of a commercial multi-sensor wearable (Fitbit Charge HR) in measuring physical activity and sleep in healthy children. PLoS One. 2020 Sep 4;15(9):e0237719. doi: 10.1371/journal.pone.0237719. eCollection 2020. — View Citation

Hatori M, Vollmers C, Zarrinpar A, DiTacchio L, Bushong EA, Gill S, Leblanc M, Chaix A, Joens M, Fitzpatrick JA, Ellisman MH, Panda S. Time-restricted feeding without reducing caloric intake prevents metabolic diseases in mice fed a high-fat diet. Cell Metab. 2012 Jun 6;15(6):848-60. doi: 10.1016/j.cmet.2012.04.019. Epub 2012 May 17. — View Citation

Honaker SM, Meltzer LJ. Sleep in pediatric primary care: A review of the literature. Sleep Med Rev. 2016 Feb;25:31-9. doi: 10.1016/j.smrv.2015.01.004. Epub 2015 Jan 24. — View Citation

Mathew GM, Hale L, Chang AM. Social jetlag, eating behaviours and BMI among adolescents in the USA. Br J Nutr. 2020 Nov 14;124(9):979-987. doi: 10.1017/S0007114520001804. Epub 2020 May 28. — View Citation

Mayne SL, Morales KH, Williamson AA, Grant SFA, Fiks AG, Basner M, Dinges DF, Zemel BS, Mitchell JA. Associations of the residential built environment with adolescent sleep outcomes. Sleep. 2021 Jun 11;44(6):zsaa276. doi: 10.1093/sleep/zsaa276. — View Citation

Meltzer LJ, Williamson AA, Mindell JA. Pediatric sleep health: It matters, and so does how we define it. Sleep Med Rev. 2021 Jun;57:101425. doi: 10.1016/j.smrv.2021.101425. Epub 2021 Jan 19. — View Citation

Miller MA, Kruisbrink M, Wallace J, Ji C, Cappuccio FP. Sleep duration and incidence of obesity in infants, children, and adolescents: a systematic review and meta-analysis of prospective studies. Sleep. 2018 Apr 1;41(4). doi: 10.1093/sleep/zsy018. — View Citation

Mindell JA, Sedmak R, Boyle JT, Butler R, Williamson AA. Sleep Well!: A Pilot Study of an Education Campaign to Improve Sleep of Socioeconomically Disadvantaged Children. J Clin Sleep Med. 2016 Dec 15;12(12):1593-1599. doi: 10.5664/jcsm.6338. — View Citation

Mitchell JA, Morales KH, Williamson AA, Huffnagle N, Eck C, Jawahar A, Juste L, Fiks AG, Zemel BS, Dinges DF. Engineering a mobile platform to promote sleep in the pediatric primary care setting. Sleep Adv. 2021 Apr 15;2(1):zpab006. doi: 10.1093/sleepadvances/zpab006. eCollection 2021. — View Citation

Mitchell JA, Morales KH, Williamson AA, Huffnagle N, Ludwick A, Grant SFA, Dinges DF, Zemel BA. Changes in Sleep Duration and Timing During the Middle-to-High School Transition. J Adolesc Health. 2020 Dec;67(6):829-836. doi: 10.1016/j.jadohealth.2020.04.024. Epub 2020 Jun 20. — View Citation

Mitchell JA, Rodriguez D, Schmitz KH, Audrain-McGovern J. Sleep duration and adolescent obesity. Pediatrics. 2013 May;131(5):e1428-34. doi: 10.1542/peds.2012-2368. Epub 2013 Apr 8. — View Citation

Njoroge WFM, Williamson AA, Mautone JA, Robins PM, Benton TD. Competencies and Training Guidelines for Behavioral Health Providers in Pediatric Primary Care. Child Adolesc Psychiatr Clin N Am. 2017 Oct;26(4):717-731. doi: 10.1016/j.chc.2017.06.002. — View Citation

Paruthi S, Brooks LJ, D'Ambrosio C, Hall WA, Kotagal S, Lloyd RM, Malow BA, Maski K, Nichols C, Quan SF, Rosen CL, Troester MM, Wise MS. Consensus Statement of the American Academy of Sleep Medicine on the Recommended Amount of Sleep for Healthy Children: Methodology and Discussion. J Clin Sleep Med. 2016 Nov 15;12(11):1549-1561. doi: 10.5664/jcsm.6288. — View Citation

Quach J, Hiscock H, Ukoumunne OC, Wake M. A brief sleep intervention improves outcomes in the school entry year: a randomized controlled trial. Pediatrics. 2011 Oct;128(4):692-701. doi: 10.1542/peds.2011-0409. Epub 2011 Sep 2. — View Citation

Spaeth AM, Hawley NL, Raynor HA, Jelalian E, Greer A, Crouter SE, Coffman DL, Carskadon MA, Owens JA, Wing RR, Hart CN. Sleep, energy balance, and meal timing in school-aged children. Sleep Med. 2019 Aug;60:139-144. doi: 10.1016/j.sleep.2019.02.003. Epub 2019 Feb 16. — View Citation

Steinberger J, Daniels SR, Hagberg N, Isasi CR, Kelly AS, Lloyd-Jones D, Pate RR, Pratt C, Shay CM, Towbin JA, Urbina E, Van Horn LV, Zachariah JP; American Heart Association Atherosclerosis, Hypertension, and Obesity in the Young Committee of the Council on Cardiovascular Disease in the Young; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Functional Genomics and Translational Biology; and Stroke Council. Cardiovascular Health Promotion in Children: Challenges and Opportunities for 2020 and Beyond: A Scientific Statement From the American Heart Association. Circulation. 2016 Sep 20;134(12):e236-55. doi: 10.1161/CIR.0000000000000441. Epub 2016 Aug 11. — View Citation

Weber DR, Moore RH, Leonard MB, Zemel BS. Fat and lean BMI reference curves in children and adolescents and their utility in identifying excess adiposity compared with BMI and percentage body fat. Am J Clin Nutr. 2013 Jul;98(1):49-56. doi: 10.3945/ajcn.112.053611. Epub 2013 May 22. — View Citation

Wheaton AG, Jones SE, Cooper AC, Croft JB. Short Sleep Duration Among Middle School and High School Students - United States, 2015. MMWR Morb Mortal Wkly Rep. 2018 Jan 26;67(3):85-90. doi: 10.15585/mmwr.mm6703a1. — View Citation

Wong CA, Miller VA, Murphy K, Small D, Ford CA, Willi SM, Feingold J, Morris A, Ha YP, Zhu J, Wang W, Patel MS. Effect of Financial Incentives on Glucose Monitoring Adherence and Glycemic Control Among Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA Pediatr. 2017 Dec 1;171(12):1176-1183. doi: 10.1001/jamapediatrics.2017.3233. — View Citation

* Note: There are 26 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Change in sleep duration The primary outcome for aims 1 and 3 is change in nighttime sleep duration (hours per night) on weeknights measured by a sleep tracker with high sensitivity and moderate specificity for measuring sleep. baseline to 12 months
Primary Change in fat mass index Z-score Aim 2 primary outcome. Total body fat mass will be measured by DXA. Fat mass index (FMI, kg of fat divided by height in meters squared) will be calculated, and age and gender specific FMI Z-scores will be determined using U.S. specific FMI growth charts. Baseline to 12 months
Secondary Change in sleep onset Change in sleep onset (time subject falls asleep). Weeknights and weekends will be measured separately. Baseline to 12 months
Secondary Change in sleep offset Change in sleep offset (time subject wakes up). Weeknights and weekends will be measured separately. Baseline to 12 months
Secondary Change in sleep midpoint Change in sleep midpoint. Weeknights and weekends will be measured separately. Baseline to 12 months
Secondary Change in social jetlag Investigators will calculate "social jetlag" by subtracting the weekend night sleep midpoint from the weeknight sleep midpoint. Social jetlag provides an indication of the discrepancy between internal biological clocks and social requirements and has been linked to cardiometabolic risk. up to 12 months
Secondary Change in sleep efficiency Change in sleep efficiency (percentage of time spent asleep during overnight sleep periods). Weeknights and weekends will be measured separately. Baseline to 12 months
Secondary Change in sleep onset latency Change in sleep onset latency (time to fall asleep). Weeknights and weekends will be measured separately. Baseline to 12 months
Secondary Change in wake after sleep onset Change in wake after sleep onset (time awake during overnight sleep periods). Weeknights and weekends will be measured separately. Baseline to 12 months
Secondary Change in sleep disturbance and impairment Measured using the the Patient-Reported Outcomes Measurement Information System (PROMIS) item bank for pediatric sleep. This validated survey generates a sleep disturbance T-score based on items related to sleep onset, sleep continuity and sleep quality in the past week. The survey also generates a sleep-related impairment T-score based on items related to daytime sleepiness, cognition, affect and behavior, and daytime activities in the past week. Higher T-scores indicates poorer sleep quality. Participants will complete this survey at baseline and at the end of each month during the intervention and follow-up periods. Baseline to 12 months
Secondary Change in visceral adipose tissue Visceral adipose tissue area will be measured by DXA. Baseline to 12 months
Secondary Change in Body Mass Index (BMI) Trained Nutrition Core staff will measure heights and weights of participants. These data will be used to calculate body mass index (kg/m2). Baseline to 12 months
Secondary Change in waist circumference Investigators will measure waist circumferences at baseline, 6-months, and 12-months. Baseline to 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2