Mobile Health App for Sleep Promotion and Obesity Prevention in Children

Recruiting in Palo Alto (17 mi)

Overseen by Jonathan Mitchell, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Children's Hospital of Philadelphia

Must not be taking: Steroids, Hormones, others

Disqualifiers: Chronic disease, Behavioral health, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of this treatment for sleep promotion and obesity prevention in children?

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 improving outcomes for children with health conditions other than obesity. Additionally, mobile health platforms have shown promise in promoting sleep in children, although specific data on their effectiveness for obesity prevention is still being developed. ^{1 2 3 4 5}

Is the mobile health app for sleep promotion and obesity prevention in children safe?

The research articles reviewed do not provide specific safety data for the mobile health app for sleep promotion and obesity prevention in children. However, they suggest that mobile health apps for sleep improvement are generally well-received and perceived to have health benefits, indicating a positive safety profile. ^{4 6 7 8 9}

How is the Mobile Health App for Sleep Promotion and Obesity Prevention in Children different from other treatments?

This treatment is unique because it combines sleep promotion with obesity prevention using a mobile health app, which is not commonly done in existing interventions. It focuses on engaging both children and parents through digital tools, aiming to improve sleep and prevent obesity by integrating health coaching, feedback, and possibly incentives, which are innovative compared to traditional methods that often focus separately on diet or physical activity. ^{2 4 9 10 11}

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Children's Hospital of Philadelphia Philadelphia, PA

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia Lead Sponsor

University of Pennsylvania Collaborator

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Engineering a mobile platform to promote sleep in the pediatric primary care setting. [2023] Pediatricians lack tools to support families at home for the promotion of childhood sleep. We are using the Multiphase Optimization Strategy (MOST) framework to guide the development of a mobile health platform for childhood sleep promotion. The objective of this study is to demonstrate feasibility of a mobile health platform towards treating children with insufficient sleep.

2. Canada pubmed.ncbi.nlm.nih.gov

A Digital Health Program Targeting Physical Activity Among Adolescents With Overweight or Obesity: Open Trial. [2023] Prior studies suggest that mobile health physical activity programs that provide only weekly or daily text-based health coaching evidence limit the efficacy in improving physical activity in adolescents with overweight or obesity. It is possible that incentives, combined with health coaching and daily feedback on goal success, may increase program efficacy; however, such programs have not yet been tested with adolescents with overweight and obesity.

3. Switzerland 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. [2023] Pediatric weight management is often hampered by poor engagement and adherence. 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 obesity. In preparation for a clinical trial comparing loss-framed to gain-framed incentives, a survey of youth and caregiver attitudes on weight management incentives, reasons for program attendance, and an economic evaluation of a theoretical trial were conducted. Ninety of 835 (11%) surveys were completed by caregiver and child. The economic evaluation showed that loss-framed incentives had a preferable incremental cost-effectiveness ratio (a lower value is considered preferable) than gain-based incentives. Most youth and caregivers felt a gain incentive would be superior, agreed that the full incentive should go to the youth (vs. the caregiver), and identified "improving health" as a top reason for pursuing weight management.

4. United States pubmed.ncbi.nlm.nih.gov

Engineering a Mobile Platform to Promote Sleep in the Pediatric Primary Care Setting. [2023] Pediatricians lack tools to support families at home for the promotion of childhood sleep. We are using the Multiphase Optimization Strategy (MOST) framework to guide the development of a mobile health platform for childhood sleep promotion.

5. United States pubmed.ncbi.nlm.nih.gov

A randomized-controlled trial of a digital, small incentive-based intervention for working adults with short sleep. [2023] We evaluated the efficacy of a digitally delivered, small and scalable incentive-based intervention program on sleep and wellbeing in short-sleeping, working adults.

6. Canada 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. [2020] There is a limited understanding of components that should be included in digital interventions for 24-hour movement behaviors (physical activity [PA], sleep, and sedentary behavior [SB]). For intervention effectiveness, user engagement is important. This can be enhanced by a user-centered design to, for example, explore and integrate user preferences for intervention techniques and features.

7. England pubmed.ncbi.nlm.nih.gov

A Qualitative Assessment of the Acceptability of Smartphone Applications for Improving Sleep Behaviors in Low-Income and Minority Adolescents. [2023] Background: Daily behaviors such as sleep can be targeted by smartphone app-based interventions, with potential utility among young people of minority ethnic backgrounds who commonly access smartphone devices and are short sleepers. There is a need to understand the acceptability and youth's readiness to use apps to improve sleep, and to identify desired app components that would motivate engagement. Participants and Methods: We conducted three focus group discussions (N&#160;=&#160;27 total, age 14-18&#160;years) within low- and middle-income ethnically diverse Boston neighborhoods. We also interviewed 10 participants who provided specific feedback on two commercially available sleep-promoting apps, one of which they had used on their smartphone preceding the interviews. All focus group discussions and interviews were audio-recorded, transcribed, and thematically analyzed. Results: We identified several barriers to adoption of sleep hygiene interventions, namely reluctance to follow scheduled sleep routines on weekends and concern about "parting" with electronics at bedtime. Participants were intrigued by the idea of adopting an app-based sleep intervention, but were skeptical that they could successfully adopt sleep hygiene practices, and were more interested in making changes on school days than on weekends. Nonetheless, the overall feedback on two commercial sleep apps, neither targeted at youth, was positive, with a good adherence and engagement rate, and perceived health benefits. Conclusions: Our findings highlight the need to adapt sleep hygiene recommendations to targeted populations, considering preferences and social and cultural contextual factors. Our research also underscores the importance of the platform, setting, and messenger when delivering health information to adolescents.

8. United States pubmed.ncbi.nlm.nih.gov

Nudging interventions to improve children's sleep, physical activity and sedentary behavior: A scoping review. [2023] In recent years, nudges to improve health behaviors have generated growing public health interest, as a promising and inexpensive intervention approach. Most nudging intervention reviews have examined nudges targeting adults, with few focusing on children. We aimed to review the literature on nudges designed to improve children's sedentary behaviors, physical activity, and sleep, and to identify existing gaps in scientific knowledge. We screened the literature for experimental and quasi-experimental studies written in French or English reporting on nudging interventions designed to improve physical activity, sedentary or sleep behavior in children aged 2-12. No setting restrictions were applied. Data extracted included setting, population, health behavior and method of measurement (reported vs measured or observed). The search was performed in June 2021 and yielded 3768 results, of which 17 articles met inclusion criteria. Most included studies aimed to improve physical activity, seven targeted sedentary behavior and only one was directed at sleep. Home or school settings were the most common. Most studies were RCTs, reported a positive effect and presented multicomponent interventions, including both nudges and non-nudge aspects. Interventions targeting the decision structure were the least represented type of nudges among our sample. Our results show a paucity of research investigating nudges aimed at improving pediatric physical activity, sedentary behavior, and sleep. Interventions using nudges alone were even fewer, highlighting the need to study this promising type of intervention to improve lifestyle behaviors of children.

9. Canada pubmed.ncbi.nlm.nih.gov

Exploring User Needs and Preferences for Mobile Apps for Sleep Disturbance: Mixed Methods Study. [2020] Mobile health (mHealth) apps demonstrate promise for improving sleep at scale. End-user engagement is a prerequisite for sustained use and effectiveness.

10. United States pubmed.ncbi.nlm.nih.gov

Inclusion of Sleep Promotion in Family-Based Interventions To Prevent Childhood Obesity. [2020] Sleep promotion in childhood may reduce the risk of obesity, but little is known of its inclusion in family-based interventions. This study examines the proportion and context of family-based interventions to prevent childhood obesity that promote child sleep. We drew on data from a recent systematic review and content analysis of family-based interventions for childhood obesity prevention published between 2008 and 2015, coupled with new data on sleep promotion strategies, designs, and measures. Out of 119 eligible family-based interventions to prevent childhood obesity, 24 (20%) promoted child sleep. In contrast, 106 (89%) interventions targeted diet, 97 (82%) targeted physical activity, and 63 (53%) targeted media use in children. Most interventions that promoted sleep were implemented in clinics (50%) and home-based settings (38%), conducted in the United States (57%), and included children 2-5 years of age (75%). While most interventions utilized a randomized controlled design (70%), only two examined the promotion of sleep independent of other energy-balance behaviors in a separate study arm. Sleep was predominately promoted by educating parents on sleep hygiene (e.g., age-appropriate sleep duration), followed by instructing parents on responsive feeding practices and limiting media use. One intervention promoted sleep by way of physical activity. A large number promoted sleep by way of bedtime routines. Most interventions measured children's sleep by parent report. Results demonstrate that sleep promotion is underrepresented and variable in family-based childhood obesity interventions. While opportunities exist for increasing its integration, researchers should consider harmonizing and being more explicit about their approach to sleep promotion.

11. Canada pubmed.ncbi.nlm.nih.gov

Targeting Parents for Childhood Weight Management: Development of a Theory-Driven and User-Centered Healthy Eating App. [2022] The proliferation of health promotion apps along with mobile phones' array of features supporting health behavior change offers a new and innovative approach to childhood weight management. However, despite the critical role parents play in children's weight related behaviors, few industry-led apps aimed at childhood weight management target parents. Furthermore, industry-led apps have been shown to lack a basis in behavior change theory and evidence. Equally important remains the issue of how to maximize users' engagement with mobile health (mHealth) interventions where there is growing consensus that inputs from the commercial app industry and the target population should be an integral part of the development process.