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Mobile Health App for Sleep Promotion and Obesity Prevention in Children

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

Must not have

Children with a history of cancer, kidney, GI, musculoskeletal, or sleep disorders

Diagnosed with a condition affecting physical growth and maturation or dietary intake

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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

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

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I am between 8 and 12 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a condition that affects my growth or how I eat.

Select...

My child is currently on steroids or hormones.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in fat mass index Z-score

Change in sleep duration

Secondary study objectives

Change in Body Mass Index (BMI)

Change in sleep disturbance and impairment

Change in sleep efficiency

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met