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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 11
Healthy Volunteers: f
View:

• 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

Locations
United States
Pennsylvania
Temple Pediatrics
RECRUITING
Philadelphia
Contact Information
Primary
Ashley Ogoe, MPH, CCRP
ashley.greer@temple.edu
215-707-5782
Backup
Chantelle N Hart, PhD
chantelle.hart@temple.edu
215-707-8639
Time Frame
Start Date: 2025-03-31
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 50
Treatments
Experimental: Behavioral Sleep Intervention
Behavioral intervention to enhance school-aged children's sleep
Other: Sleep Education
Sleep Education
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Temple University

This content was sourced from clinicaltrials.gov

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