Recruiting

Behavioral Sleep Intervention

Sponsor:

Temple University

Code:

NCT06810557

Conditions

Obesity, Childhood

Short Sleep

Obesity Prevention

Eligibility Criteria

Sex: All

Age: 6 - 11

Healthy Volunteers: Not accepted

Interventions

Optimize Sleep Primary Care (OSPC)

Enhanced Usual Care

Study Details

Brief 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.

Conditions

Obesity, Childhood

Short Sleep

Obesity Prevention

Study ID

NCT06810557

Start date

May 15, 2025

Status verified date

Feb, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 11

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Behavioral Sleep Intervention

Behavioral intervention to enhance school-aged children's sleep

other: Sleep Education

Sleep Education

Interventions

Optimize 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.

Enhanced 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.

Primary outcome measure

  • Achievement of enrollment goal [ Time Frame: baseline ]
  • The number of providers who participate and refer to the intervention [ Time Frame: baseline ]
  • Average family attendance at intervention sessions [ Time Frame: baseline to 6 months ]
  • Nurse percent fidelity/accuracy in delivering the intervention [ Time Frame: baseline to 6 months ]
  • Percent of families who are retained in the study at both follow-up time points [ Time Frame: baseline to 6 months ]
  • Family assessment of the intervention's acceptability [ Time Frame: baseline to 6 months ]

Central Contacts and Locations

Central contacts

Ashley Ogoe, MPH, CCRP

215-707-5782ashley.greer@temple.edu

Chantelle N Hart, PhD

215-707-8639chantelle.hart@temple.edu

Locations

Temple Pediatrics

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Ashley Ogoe, MPH

215-707-5782ashley.greer@temple.edu

More Information

Sponsor

Temple University

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Temple University on 2026-02-12.