RECRUITING

Brief Behavioral Sleep Intervention for Obesity Prevention in Primary Care

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-01
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06810557

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 11 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Patient at Temple Pediatrics
  2. * Child age 6-11 years
  3. * Child time in bed of less than 9 hours per night on most days per week
  4. * Body Mass Index (BMI) for age and biological sex great than the 10th percentile but less than the 95th percentile
  5. * Understanding of and ability to complete the protocol
  6. * Parent age at least 18 years and primary caregiver
  7. * Willingness to be randomized to either condition
  1. * Diagnosed sleep disorder
  2. * Medication use or diagnosis of medical or psychiatric condition that may impact sleep or weight status
  3. * Current or planned treatment for weight control

Contacts and Locations

Study Contact

Ashley Ogoe, MPH, CCRP
CONTACT
215-707-5782
ashley.greer@temple.edu
Chantelle N Hart, PhD
CONTACT
215-707-8639
chantelle.hart@temple.edu

Principal Investigator

Chantelle N Hart, PhD
PRINCIPAL_INVESTIGATOR
Temple University

Study Locations (Sites)

Temple Pediatrics
Philadelphia, Pennsylvania, 19140
United States

Collaborators and Investigators

Sponsor: Temple University

  • Chantelle N Hart, PhD, PRINCIPAL_INVESTIGATOR, Temple University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-01
Study Completion Date2026-10

Study Record Updates

Study Start Date2025-02-01
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

  • sleep
  • behavioral intervention
  • primary care
  • obesity prevention
  • child
  • pediatric

Additional Relevant MeSH Terms

  • Obesity, Childhood
  • Short Sleep
  • Obesity Prevention