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Condition 16 for Obesity

N/A
Recruiting
Led By Jonathan Mitchell, PhD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body mass index (BMI) between the 50th and 95th percentile for age and sex
Aged 8-12 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study Summary

This trial aims to create a mobile health app for pediatric care that helps children sleep longer to prevent obesity.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves non-medical interventions such as digital messaging and goal-setting via an app platform rather than medication or invasive procedures, there are no direct physical side effects expected from participating in this study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My BMI is between the 50th and 95th percentile for my age and sex.
Select...
I am between 8 and 12 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in fat mass index Z-score
Change in sleep duration
Secondary outcome measures
Change in Body Mass Index (BMI)
Change in sleep disturbance and impairment
Change in sleep efficiency
+8 more

Trial Design

16Treatment groups
Experimental Treatment
Active Control
Group I: Condition 16Experimental Treatment4 Interventions
Core intervention, Sleep goal, Sleep guidance messaging, Caregiver-directed loss-framed incentive, Supportive feedback.
Group II: Condition 4Active Control4 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 1Active Control4 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 3Active Control4 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 2Active Control4 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 5Active Control4 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 6Active Control4 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 7Active Control4 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 8Active Control4 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 9Active Control4 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 10Active Control4 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 11Active Control4 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 12Active Control4 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 13Active Control4 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 14Active Control4 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 15Active Control4 Interventions
Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaOTHER
2,015 Previous Clinical Trials
42,869,026 Total Patients Enrolled
88 Trials studying Obesity
72,467 Patients Enrolled for Obesity
Children's Hospital of PhiladelphiaLead Sponsor
710 Previous Clinical Trials
8,583,908 Total Patients Enrolled
10 Trials studying Obesity
1,260 Patients Enrolled for Obesity
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,977 Previous Clinical Trials
2,675,797 Total Patients Enrolled
105 Trials studying Obesity
97,323 Patients Enrolled for Obesity
~3333 spots leftby Jun 2027
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