Clinical trial Recruiting at 1 site Interventional Ages 6 to 11

Behavioral sleep intervention for preventing obesity in children

Official title: Feasibility and Preliminary Efficacy of a Brief Behavioral Sleep Intervention for Excessive Weight Gain Prevention in Primary Care

Run by Temple University · NCT06810557 · Data updated 2026-11-12

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

Study typeInterventional
Ages6 Years to 11 Years
SexAll
Enrollment50 (estimated)
SponsorTemple University
Academic / other
Locations1 site (Philadelphia, Pennsylvania)
StatusRecruiting
StartedMay 15, 2025
Main results expectedNovember 30, 2026
Study endsMarch 31, 2027
Registry record updatedFebruary 12, 2026
Trial IDNCT06810557 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients with diagnosed sleep disorders or those currently undergoing treatment for weight control may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies have shown promise in using behavioral interventions to improve sleep and prevent obesity, indicating this approach may be effective.

Who can join: the full rules

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 it's running

  • Temple Pediatrics
    Philadelphia, Pennsylvania, United States
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.