Behavioral sleep intervention for preventing obesity in children
Feasibility and Preliminary Efficacy of a Brief Behavioral Sleep Intervention for Excessive Weight Gain Prevention in Primary Care
This study is testing whether helping children aged 6-11 from lower-income families improve their sleep with personal coaching or educational materials can prevent obesity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 6 Years to 11 Years |
| Sex | All |
| Sponsor | Temple University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06810557 on ClinicalTrials.gov |
What this trial studies
This study aims to compare two approaches to improve nighttime sleep in children aged 6-11 years who sleep less than 9 hours per night. Families will either work one-on-one with a nurse to learn behavioral strategies to enhance sleep or receive educational materials about the benefits of good sleep. The study will involve six sessions over six months, with assessments at the start, 2 months, and 6 months to evaluate sleep duration, physical activity, and dietary habits. The focus is on children from lower socioeconomic backgrounds, primarily African American or Black, to assess the feasibility and effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates are children aged 6-11 years who sleep less than 9 hours per night and have a BMI between the 10th and 95th percentiles.
Not a fit: Patients with diagnosed sleep disorders or those currently undergoing treatment for weight control may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could help improve sleep duration in children, potentially reducing the risk of obesity.
How similar studies have performed: Other studies have shown promise in using behavioral interventions to improve sleep and prevent obesity, indicating this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient at Temple Pediatrics * Child age 6-11 years * Child time in bed of less than 9 hours per night on most days per week * Body Mass Index (BMI) for age and biological sex great than the 10th percentile but less than the 95th percentile * Understanding of and ability to complete the protocol * Parent age at least 18 years and primary caregiver * Willingness to be randomized to either condition Exclusion Criteria: * Diagnosed sleep disorder * Medication use or diagnosis of medical or psychiatric condition that may impact sleep or weight status * Current or planned treatment for weight control
Where this trial is running
Philadelphia, Pennsylvania
- Temple Pediatrics — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Chantelle N Hart, PhD — Temple University
- Study coordinator: Ashley Ogoe, MPH, CCRP
- Email: ashley.greer@temple.edu
- Phone: 215-707-5782
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.