Brief Behavioral Sleep Intervention for Obesity Prevention in Primary Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-11
SponsorTemple University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Optimize Sleep Primary Care (OSPC)
BehavioralIn 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
Other interventionIn 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Behavioral Sleep InterventionExperimental treatment 1 intervention
Group B: Sleep EducationOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
baseline2
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.
Time frame
baseline3
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.
Time frame
baseline to 6 months4
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.
Time frame
baseline to 6 monthsSecondary outcomes
1
Preliminary Effectiveness: Sleep
Measured with actigraphy over 7 days at each assessment and scored with the assistance of sleep diaries and call-ins to time-stamped voicemail. Primary variable of interest is change in the actigraph-estimated sleep period, which is the time between actigraph-estimated bedtime and wake time.
Time frame
baseline to 6 months2
Preliminary Effectiveness: Weight Status
Child height and weight will be measured by staff to calculate body mass index (BMI). Change in BMI (controlling for child age and biological sex) is of primary interest.
Time frame
baseline to 6 months3
Preliminary Effectiveness: Diet - Caloric Intake
Measured with 24-hour dietary recalls on two days (one weekday and one weekend day). Mean reported caloric intake will be computed.
Time frame
baseline to 6 months4
Preliminary Effectiveness: Diet - Percent Calories from Fat
Measured with 24-hour dietary recalls on two days (one weekday and one weekend day). Mean reported percent calories from fat will be computed.
Time frame
baseline to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Temple University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov