Brief Behavioral Sleep Intervention for Childhood Obesity Prevention
This study is looking at two ways to help children aged 6-11 improve their sleep and prevent obesity. One group will receive "Optimize Sleep Primary Care (OSPC)", which involves working with a nurse through Zoom and phone calls to learn sleep strategies. The other group will receive "Enhanced Usual Care," which provides educational materials about children's sleep. The study aims to see if these approaches help children sleep better and how many families and providers participate. We don't know the current status of recruitment, but the study plans to enroll 50 children. To join, children must be patients at Temple Pediatrics, aged 6-11, sleep less than 9 hours per night, and have a BMI between the 10th and 95th percentile. Parents must be at least 18 and willing to participate.
- Study design
- This interventional study plans to enroll 50 children who will be randomly assigned to one of two groups. It is not specified if the study is blinded.
- What's involved
- Participating families will have 6 contacts with a nurse or receive 6 educational handouts over 6 months. They will also complete three assessments, including questionnaires, wearing sleep/activity devices, reporting food intake, and having height and weight measured.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 6 months after the start of the study.
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Brief Behavioral Sleep Intervention for Obesity Prevention in Primary Care
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Chantelle N Hart, PhD · PRINCIPAL_INVESTIGATOR · Temple University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Achievement of enrollment goalbaseline
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.
- The number of providers who participate and refer to the interventionbaseline
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.
- Average family attendance at intervention sessionsbaseline to 6 months
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.
- Nurse percent fidelity/accuracy in delivering the interventionbaseline to 6 months
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.
- Percent of families who are retained in the study at both follow-up time pointsbaseline to 6 months
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.
- Family assessment of the intervention's acceptabilitybaseline to 6 months
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.