Mobile Health App for Sleep Promotion and Obesity Prevention in Children

Overseen By Abby Salem

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Must not be taking: Steroids, Hormones, others

Disqualifiers: Chronic disease, Behavioral health, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

5000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile health app designed to improve children's sleep and prevent obesity. It evaluates various strategies, such as setting sleep goals and sending digital health messages, to determine their effectiveness. Children who sleep less than 8.5 hours a night and have a BMI between the 50th and 95th percentile are ideal candidates. The goal is to discover how better sleep can aid in managing weight and overall health in kids. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance children's health and well-being.

Do I have to stop taking my current medications to join the trial?

The trial requires that children not be regularly taking medications to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that specific safety information for the mobile health app used in this study, which aims to improve sleep and prevent obesity in children, is not available. The trial's treatments are digital, focusing on setting sleep goals and providing health messages. These methods are generally considered non-invasive, meaning they don't involve surgery or injections, and are likely well-tolerated.

Previous studies on similar mobile health tools have not identified major safety issues. The digital approach is designed to help increase sleep time, a common goal in many sleep studies. This suggests that the methods could be safe, as they focus on changing behaviors rather than using medications or physical treatments.

This trial is labeled as "Not Applicable" for phase, indicating it is not an FDA-regulated drug or device trial. This suggests that the interventions are less likely to have serious safety concerns. As always, discussing any concerns with the trial coordinators or a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to promote better sleep and prevent obesity in children using a mobile health app. Unlike traditional treatments like medication or behavioral therapy, this approach leverages digital sleep health messaging and personalized sleep goals, making it more accessible and interactive for families. By incorporating parent-directed incentives and supportive feedback, the trial aims to actively engage caregivers in their child's sleep improvement journey. This method could offer a more engaging and adaptable solution, leading to healthier sleep patterns and reduced obesity risks in children.

What evidence suggests that this trial's treatments could be effective for promoting longer sleep duration and preventing childhood obesity?

This trial will evaluate various strategies to improve sleep in children, which links to a lower risk of obesity. Participants in different arms of this trial will receive different interventions. Some will encounter loss-framed incentives, where participants lose a reward if they don't meet their sleep goals. Studies have shown this method can be more effective than others in changing sleep habits. Others will use mobile health platforms with digital messages, which research indicates can help improve sleep duration in children. Some arms will focus on setting a fixed sleep goal to establish regular sleep patterns, potentially preventing obesity. Meanwhile, other arms might use personalized sleep goals to boost confidence in getting more sleep by tailoring goals to individual needs. ^{1 2 6 7 8}

Who Is on the Research Team?

Jonathan Mitchell, PhD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for children aged 8-12 with sleep issues (less than 8.5 hours of sleep per night) and a BMI between the 50th and 95th percentile. It's open to one child per family, but not for those with cancer, chronic diseases, behavioral health problems, conditions affecting sleep or growth, or kids taking steroids/hormones.

Inclusion Criteria

Insufficient sleep duration (<8.5 hours per night)

My BMI is between the 50th and 95th percentile for my age and sex.

One child per family

Exclusion Criteria

My child has a history of cancer or issues with kidneys, digestion, bones, or sleep.

I have been diagnosed with a long-term illness.

Diagnosed with a behavioral health problem

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

Participants undergo a 2-week run-in period to establish baseline sleep patterns

2 weeks

Intervention

Participants receive the mobile health platform intervention to promote longer sleep duration

6 months

Remote monitoring and virtual consultations as needed

Follow-up

Participants are monitored for changes in sleep duration and obesity-related measures

5.5 months

What Are the Treatments Tested in This Trial?

Interventions

• Active Parent-Directed Loss-Framed Incentive
• Active Supportive Feedback
• Digital sleep health messaging without virtual study visit
• Digital sleep health messaging with virtual study visit
• Fixed sleep goal
• Inactive Parent-Directed Loss-Framed Incentive
• Inactive Supportive Feedback
• Personalized sleep goal

Trial Overview The study aims to develop a mobile app that helps kids sleep longer as a way to prevent obesity. It tests different features like setting fixed or personalized sleep goals, providing feedback on progress, and whether digital messages about sleep health are more effective with or without virtual visits.

How Is the Trial Designed?

Group I: Condition 16 Experimental Treatment 4 Interventions

Core intervention, Sleep goal, Sleep guidance messaging, Caregiver-directed loss-framed incentive, Supportive feedback.

Group II: Condition 4 Active Control 4 Interventions

Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.

Group III: Condition 1 Active Control 4 Interventions

Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.

Group IV: Condition 3 Active Control 4 Interventions

Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.

Group V: Condition 2 Active Control 4 Interventions

Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.

Group VI: Condition 5 Active Control 4 Interventions

Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.

Group VII: Condition 6 Active Control 4 Interventions

Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.

Group VIII: Condition 7 Active Control 4 Interventions

Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.

Group IX: Condition 8 Active Control 4 Interventions

Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.

Group X: Condition 9 Active Control 4 Interventions

Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.

Group XI: Condition 10 Active Control 4 Interventions

Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.

Group XII: Condition 11 Active Control 4 Interventions

Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.

Group XIII: Condition 12 Active Control 4 Interventions

Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.

Group XIV: Condition 13 Active Control 4 Interventions

Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.

Group XV: Condition 14 Active Control 4 Interventions

Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.

Group XVI: Condition 15 Active Control 4 Interventions

Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A mobile health platform was successfully developed to promote better sleep in children aged 10-12, capturing sleep data from 1,514 nights in Study #1 and 2,689 nights in Study #2, demonstrating its feasibility for remote family support.

In Study #1, children receiving loss-framed incentives showed an increase in sleep duration by an average of 34 minutes per night compared to controls, indicating that incentive-based strategies may effectively improve sleep habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engineering a Mobile Platform to Promote Sleep in the Pediatric Primary Care Setting. Mitchell, JA., Morales, KH., Williamson, AA., et al.[2023]

A review of 17 studies on nudging interventions for children aged 2-12 revealed that most efforts focused on increasing physical activity, with very few targeting sedentary behavior or sleep, indicating a significant gap in research.

Most studies reported positive effects and utilized multicomponent interventions, but there is a need for more research specifically on nudges alone to effectively improve children's lifestyle behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nudging interventions to improve children's sleep, physical activity and sedentary behavior: A scoping review. Diamant, É., Perez, T., Drouin, O.[2023]

A 12-week mobile health program combining text-based coaching, goal setting, and incentives was well-accepted by adolescents with overweight or obesity, with high adherence rates (91.1% of days wearing a Fitbit) and positive feedback on the program.

Participants showed significant improvements in physical activity, with increased daily active minutes and steps, as well as a reduction in body fat percentage, indicating the program's efficacy in promoting healthier behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Digital Health Program Targeting Physical Activity Among Adolescents With Overweight or Obesity: Open Trial. Cummings, C., Crochiere, R., Lansing, AH., et al.[2023]

In a 22-week study involving 225 short-sleeping adults, a digitally delivered incentive program showed short-term improvements in sleep duration and reduced morning sleepiness, particularly in the Goal-Setting group who received health vouchers for meeting sleep goals.

While the Goal-Setting group experienced a slight increase in time-in-bed and earlier bedtimes during the initial weeks, the overall sleep outcomes did not differ significantly from the Control group, suggesting that more structural changes may be needed to achieve lasting improvements in sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized-controlled trial of a digital, small incentive-based intervention for working adults with short sleep. Ong, JL., Massar, SAA., Lau, T., et al.[2023]

A mobile health platform was developed to promote better sleep in children aged 10-12 years, showing feasibility in capturing sleep data and communicating with families.

In the first study with 30 participants, children receiving gain-framed and loss-framed incentives increased their sleep duration by an average of 21 and 34 minutes per night, respectively, compared to controls, indicating potential effectiveness of incentive-based interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engineering a mobile platform to promote sleep in the pediatric primary care setting. Mitchell, JA., Morales, KH., Williamson, AA., et al.[2023]

A study involving 176 participants (9 in focus groups and 167 in an online survey) identified that users with poor sleep prefer personalized features in a sleep app, such as sleep diaries and alarms, to enhance engagement and effectiveness.

Most participants (93%) expressed willingness to try an evidence-based sleep app, highlighting the importance of tailoring app functionalities to user needs, especially for those with severe insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring User Needs and Preferences for Mobile Apps for Sleep Disturbance: Mixed Methods Study. Aji, M., Gordon, C., Peters, D., et al.[2020]

Out of 119 family-based interventions aimed at preventing childhood obesity, only 24 (20%) included strategies to promote child sleep, indicating that sleep promotion is currently underrepresented in these programs.

Most sleep-promoting interventions focused on educating parents about sleep hygiene and establishing bedtime routines, but only two studies examined sleep promotion independently, suggesting a need for more targeted research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inclusion of Sleep Promotion in Family-Based Interventions To Prevent Childhood Obesity. Agaronov, A., Ash, T., Sepulveda, M., et al.[2020]

A new healthy eating app for parents was developed using a systematic approach that combined behavior change theory and user-centered design, informed by focus groups with 46 participants, including parents and experts in childhood weight management.

The app targets the key behavior of helping parents provide appropriate food portion sizes for their children, incorporating features that enhance user engagement, such as gamification elements like points and quizzes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting Parents for Childhood Weight Management: Development of a Theory-Driven and User-Centered Healthy Eating App. Curtis, KE., Lahiri, S., Brown, KE.[2022]

A study involving 27 young participants (ages 14-18) from diverse backgrounds revealed that while they were interested in using smartphone apps to improve sleep, they faced barriers such as reluctance to change sleep routines on weekends and concerns about using electronics at bedtime.

Feedback on two commercially available sleep apps was generally positive, indicating good adherence and perceived health benefits, suggesting that app-based interventions could be effective if tailored to the specific needs and preferences of young people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Qualitative Assessment of the Acceptability of Smartphone Applications for Improving Sleep Behaviors in Low-Income and Minority Adolescents. Quante, M., Khandpur, N., Kontos, EZ., et al.[2023]

A study involving 86 adult participants identified that users prefer mobile app features that provide information on health consequences, behavioral feedback, and tips for healthy lifestyles, particularly for physical activity (PA) compared to sleep and sedentary behavior (SB).

To enhance user engagement in digital interventions, apps should focus on self-monitoring, health outcome information, and feedback, while also considering the inclusion of a virtual coach and video modeling, especially for users less active in PA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adults' Preferences for Behavior Change Techniques and Engagement Features in a Mobile App to Promote 24-Hour Movement Behaviors: Cross-Sectional Survey Study. DeSmet, A., De Bourdeaudhuij, I., Chastin, S., et al.[2020]

A survey of 90 participants (caregivers and children) indicated that loss-framed incentives for weight management may be more cost-effective than gain-framed incentives, suggesting a potential strategy for improving engagement in pediatric weight management programs.

Despite the economic advantages of loss-framed incentives, most youth and caregivers preferred gain incentives and emphasized 'improving health' as a primary motivation for participating in weight management programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Loss and Gain Incentives on Adherence in Pediatric Weight Management: Preliminary Studies and Economic Evaluation of a Theoretical Trial. Siegel, R., McGrady, ME., Dynan, L., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-sleep-deprivation-2-2023-76aaf

Mobile Health App for Sleep Promotion and Obesity ... Research suggests that loss-framed incentives (where participants lose a reward if they don't meet goals) are more effective than gain-based incentives in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6450425/

Assessment of Parents' Preferences for Incentives to ... This survey study assesses preferences of parents of children with obesity for incentive attributes and levels in family-based treatment programs for childhood ...

3. reporter.nih.gov reporter.nih.gov/search/VEW-LrKwXkGW9GG4QyfE3g/project-details/10850565

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

4. medrxiv.org medrxiv.org/content/10.1101/2023.01.04.23284151v1.full.pdf

Promoting Sleep Duration in the Pediatric Setting Using a ... Specifically, we discovered that sleep tracking, performance feedback, a sleep goal, a caregiver- directed loss-framed incentive, and messaging ...

5. researchgate.net researchgate.net/publication/366911482_Promoting_Sleep_Duration_in_the_Pediatric_Setting_Using_a_Mobile_Health_Platform_A_Randomized_Optimization_Trial

Promoting Sleep Duration in the Pediatric Setting Using a ... ... directed loss-framed financial incentive (inactive or active). The primary outcome was weeknight sleep duration (hours per night). The ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9819945/

Effects of Loss and Gain Incentives on Adherence in ... Incentives based on loss have been shown to be more effective than gain-based incentives in improving outcomes among children with health conditions other than ...

7. news-medical.net news-medical.net/news/20250910/Early-parent-focused-programs-fail-to-reduce-childhood-obesity-by-age-two.aspx

Early parent-focused programs fail to reduce childhood ... With a high level of certainty, the meta-analysis found that the early childhood obesity prevention programs had no effect on BMI of the ...

8. researchgate.net researchgate.net/publication/49793413_Obesity_prevention_in_the_family_day_care_setting_Impact_of_the_Romp_Chomp_intervention_on_opportunities_for_children's_physical_activity_and_healthy_eating

Obesity prevention in the family day care setting Abstract. The Romp & Chomp intervention reduced the prevalence of overweight/obesity in pre-school children in Geelong, Victoria, Australia ...