RecruitingNot ApplicableNCT06810557

Brief Behavioral Sleep Intervention for Obesity Prevention in Primary Care

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


Sponsor

Temple University

Enrollment

50 participants

Start Date

May 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 6 YearsMax Age: 11 Years

Inclusion Criteria7

  • 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 Criteria3

  • 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

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Interventions

BEHAVIORALOptimize Sleep Primary Care (OSPC)

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.

OTHEREnhanced Usual Care

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.


Locations(1)

Temple Pediatrics

Philadelphia, Pennsylvania, United States

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NCT06810557


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