Actively Recruiting

Phase Not Applicable
Age: 6Years - 11Years
All Genders
ID06810557

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

Led by Temple University · Updated on 2026-02-12

50

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

Sponsors

T

Temple University

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating two approaches to help families with children aged 6 to 11 years improve nighttime sleep and prevent obesity. The study focuses on children who typically sleep less than 9 hours per night and aims to assess the feasibility and preliminary effectiveness of a brief behavioral intervention compared to sleep education. The trial is conducted with children primarily from African American/Black backgrounds and lower socioeconomic groups. Participants will be randomly assigned to one of two groups: the Optimize Sleep Primary Care (OSPC) behavioral intervention or Enhanced Usual Care (EUC). The OSPC group receives a nurse-delivered program including two video sessions and four phone follow-ups focusing on behavioral strategies to increase sleep by about one hour per night. The EUC group receives six educational contacts about sleep benefits and needs. Both groups continue with standard pediatric care throughout the six-month study. Families will complete three assessments at the start, 2 months, and 6 months, including questionnaires, sleep and physical activity monitoring using devices, dietary recalls on two days, and height and weight measurements. Researchers will track enrollment, provider engagement, session attendance, intervention delivery accuracy, family retention, and acceptability. They will also measure changes in sleep duration, diet, physical activity, sedentary behavior, and weight status over six months.

CONDITIONS

Brief Title

Brief Behavioral Sleep Intervention for Obesity Prevention in Primary Care

Who Can Participate

Age: 6Years - 11Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 greater 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 6 months

Participants receive either a brief behavioral sleep intervention or sleep education delivered through a combination of zoom sessions and phone follow-ups over six months to help improve children's sleep duration and prevent excessive weight gain.

4 intervention contacts (2 zoom sessions and 2 phone follow-ups) during the first 2 months, plus 2 additional phone follow-ups during months 2 to 6

Follow-up

Duration - 6 months

Participants are assessed at baseline, 2 months, and 6 months for sleep duration, eating behaviors, physical activity, and anthropometric measures to evaluate intervention effectiveness and maintenance.

3 assessment visits (baseline, 2 months, and 6 months)

Trial Site Locations

Total: 1 location

1

Temple Pediatrics

Philadelphia, Pennsylvania, United States, 19140

Actively Recruiting

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Research Team

A

Ashley Ogoe, MPH, CCRP

C

Chantelle N Hart, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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