Brief Behavioral Sleep Intervention for Obesity Prevention in Primary Care

NCT06810557 | Recruiting DMC

• 1 other identifier: R01DK139665
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Achievement of enrollment goal

  Primary variable of interest is achievement of a priori goals for study enrollment (i.e., whether 50 families enroll in the study). We will also explore: of children referred, the number who enroll; and of children who are referred and eligible, the number who enroll.

  baseline

• The number of providers who participate and refer to the intervention

  Of all pediatric providers in the clinic, the number who attend the initial in-service training and the number of referrals each provider makes to the program. Attendance and the number of referrals will be tracked by study staff.

  baseline

• Average family attendance at intervention sessions

  Whether or not families attend each treatment sessions will be captured by the study nurse. Primary variable of interest is whether families, on average, achieve \> 75% attendance at all intervention sessions.

  baseline to 6 months

• Nurse percent fidelity/accuracy in delivering the intervention

  All intervention sessions are recorded to determine the accuracy with which nurses deliver the intervention. Specifically, trained staff review recordings and use a checklist to mark whether or not each intervention component is delivered during each session. Primary variable of interest is whether the nurse delivers the intervention with at least 80% fidelity/accuracy.

  baseline to 6 months

• Percent of families who are retained in the study at both follow-up time points

  Retention at both 2- and 6-months will be tracked by study staff and compared across study arms with a goal of at least 80% retention at two months.

  baseline to 6 months

• Family assessment of the intervention's acceptability

  Acceptability will be measured by families' responses to the overall acceptability question on the Theoretical Framework for Acceptability (TFA) Acceptability Scale. Specifically, families use a 5-point, likert-type scale ranging from 'completely unacceptable' to 'completely acceptable' to rate the intervention. The percent of families who rate the intervention as 'acceptable' or 'completely acceptable' will be assessed with a goal of at least 80% of families rating it as such.

  baseline to 6 months

Secondary Outcomes (6)

• Preliminary Effectiveness: Sleep

  baseline to 6 months

• Preliminary Effectiveness: Weight Status

  baseline to 6 months

• Preliminary Effectiveness: Diet - Caloric Intake

  baseline to 6 months

• Preliminary Effectiveness: Diet - Percent Calories from Fat

  baseline to 6 months

• Preliminary Effectiveness: Physical Activity

  baseline to 6 months

Study Arms (2)

Behavioral Sleep Intervention

EXPERIMENTAL

Behavioral intervention to enhance school-aged children's sleep

Behavioral: Optimize Sleep Primary Care (OSPC)

Sleep Education

OTHER

Sleep Education

Other: Enhanced Usual Care

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.

Behavioral Sleep Intervention

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.

Sleep Education

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Temple University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Temple Pediatrics

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chantelle N Hart, PhD

  Temple University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Ogoe, MPH, CCRP

CONTACT

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

Chantelle N Hart, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: February 5, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be made available by the end of the award and will remain available for at least 5 years.

Locations

US (1)