Brief Behavioral Sleep Intervention for Obesity Prevention in Primary Care

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Temple University
Study ID
NCT06810557
Status
Recruiting
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Conditions

  • Obesity Prevention
  • Obesity, Childhood
  • Short Sleep

Eligibility Criteria

Sex
ALL
Age
6 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • Optimize Sleep Primary Care (OSPC) — BEHAVIORAL
    In addition to standard care within Temple University Primary Care (TUPC), two face-to-face zoom sessions and four brief phone follow-ups (two during active treatment and two during maintenance) that focus on using effective behavioral strategies (e.g., goal setting, self-monitoring, positive reinforcement, stimulus control, problem-solving) to enhance children's sleep by approximately one hour/night.
  • Enhanced Usual Care — OTHER
    In addition to standard care within Temple University Primary Care (TUPC), the provision of six education contacts regarding children's sleep needs and the benefits of getting a good night's sleep.

Study Details

The goal of this study is to compare two different approaches to help families with children 6-11 years enhance nighttime sleep: 1) working one-on-one with a nurse to learn effective behavioral strategies to try to improve children's sleep or 2) receiving education on a good night's sleep and its benefits. Participating families will meet with a nurse 6 times or receive 6 educational handouts. Participating families will also complete three assessments (start of the study, 2 months and 6 months) during which study questionnaires will be completed, participating children will wear devices that assess sleep and physical activity, participating families will report on what the child ate on two separate days and will be measured for height and weight.

Key Dates

Start date
May 15, 2025
Status verified
Feb 2026
Primary completion
Nov 30, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Behavioral Sleep Intervention
    Behavioral intervention to enhance school-aged children's sleep
  • Other: Sleep Education
    Sleep Education

Primary Outcome Measure

Achievement of enrollment goal [ Time Frame: baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Temple PediatricsPhiladelphiaPennsylvania19140
Ashley Ogoe, MPH
[email protected]
215-707-5782

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By research site
Temple Pediatrics· Philadelphia, PA

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