Clinical trial NCT06810557: Brief Behavioral Sleep Intervention for Obesity Prevention in Primary Care
Official title: Feasibility and Preliminary Efficacy of a Brief Behavioral Sleep Intervention for Excessive Weight Gain Prevention in Primary Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Childhood
Short Sleep
Obesity Prevention
Keywords: sleep
behavioral intervention
primary care
obesity prevention
child
pediatric
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2025-02-05
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: The present study is assessing the feasibility and preliminary effectiveness of a brief behavioral intervention to enhance children's sleep and prevent development of obesity. Fifty short sleeping (\< 9 hours/night) children 6-11 years old who are primarily AA/Black and from lower socioeconomic backgrounds will be enrolled into a 6-month study. Children will be randomly assigned to 1 of 2 conditions: 1) optimize sleep primary care (OSPC; behavioral intervention to enhance sleep duration delivered by a nurse in primary care) or 2) enhanced usual care (EUC; usual care plus sleep education). All children will receive standard pediatric care. Families randomized to OSPC will receive a four-session intervention (two zoom-delivered sessions and two brief phone follow-ups) over the first two months with two additional phone follow-ups during maintenance (months 2-6). Families randomized to EUC will receive sleep education that is delivered at the same points of contact as OSPC sessions. At baseline, end of treatment (2 months), and 6 months, the following will be measured from a Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) perspective: reach (e.g., enrollment), adoption (e.g., pediatric provider engagement), implementation (e.g., session attendance, treatment fidelity), maintenance (e.g., retention), and preliminary effectiveness (e.g., changes in sleep duration (actigraphy), eating behaviors (24-hour dietary recalls), physical activity (accelerometry), and anthropometrics (measured height and weight).

Eligibility criteria: 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

Primary outcomes:
measure: Achievement of enrollment goal
timeFrame: baseline
measure: The number of providers who participate and refer to the intervention
timeFrame: baseline
measure: Average family attendance at intervention sessions
timeFrame: baseline to 6 months
measure: Nurse percent fidelity/accuracy in delivering the intervention
timeFrame: baseline to 6 months
measure: Percent of families who are retained in the study at both follow-up time points
timeFrame: baseline to 6 months
measure: Family assessment of the intervention's acceptability
timeFrame: baseline to 6 months
Secondary outcomes:
measure: Preliminary Effectiveness: Sleep
timeFrame: baseline to 6 months
measure: Preliminary Effectiveness: Weight Status
timeFrame: baseline to 6 months
measure: Preliminary Effectiveness: Diet - Caloric Intake
timeFrame: baseline to 6 months
measure: Preliminary Effectiveness: Diet - Percent Calories from Fat
timeFrame: baseline to 6 months
measure: Preliminary Effectiveness: Physical Activity
timeFrame: baseline to 6 months
measure: Preliminary Effectiveness: Sedentary Activity
timeFrame: baseline to 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple Pediatrics
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Chantelle N Hart, PhD
role: PRINCIPAL_INVESTIGATOR
References: