Brief Behavioral Sleep Intervention for Obesity Prevention in Primary Care
Purpose
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
Eligibility
- Eligible Ages
- Between 6 Years and 11 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Behavioral Sleep Intervention |
Behavioral intervention to enhance school-aged children's sleep |
|
|
Other Sleep Education |
Sleep Education |
|
Recruiting Locations
Philadelphia 4560349, Pennsylvania 6254927 19140
More Details
- Status
- Recruiting
- Sponsor
- Temple University
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).