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Clinical Trials/NCT03186508
NCT03186508
Completed
Not Applicable

Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors-Renewal

Temple University1 site in 1 country149 target enrollmentFebruary 28, 2018
ConditionsObesitySleep

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Temple University
Enrollment
149
Locations
1
Primary Endpoint
Change in BMIz
Status
Completed
Last Updated
last year

Overview

Brief Summary

Enhancing children's sleep may be a novel approach for prevention of obesity and cardiovascular (CV) disturbance. Observational studies with children demonstrate that short sleep increases risk of obesity and other CV risk factors. Randomized controlled trials with children 8-11 years old demonstrate that enhancing sleep duration leads to positive changes in eating and activity behaviors and weight status, particularly for children who enhance their sleep the most. Enhancing sleep may be particularly important for racial minority children and those from lower socioeconomic backgrounds given their increased risk for short sleep, obesity and CV risk factors. In this study two active obesity preventive interventions will be evaluated: a) enhancing sleep alone (Optimize Sleep [OS]), and b) enhancing sleep along with eating and activity behaviors that have demonstrated efficacy for obesity prevention and are implicated in self-regulatory pathways related to sleep (i.e., energy dense snack foods and beverages, TV viewing, and physical activity) (OS-Plus). Two hundred four children 6-11 years old who are primarily African American/black, primarily from low socioeconomic backgrounds, and who sleep < 9.5 hours/night into a 12-month study will be enrolled. Children will be randomly assigned to either OS or OS-Plus. Over the 6-month treatment phase, all children will attend an 8-session treatment; monthly phone contacts will occur during maintenance (6-12 months). Primary aim is to determine the efficacy of OS-Plus relative to OS on change in body mass index z-score (BMIz) at end of treatment. Secondary aims will assess efficacy of OS-Plus relative to OS on additional cardiometabolic risk factors, eating and activity behaviors. Exploratory aims will assess maintenance of effects at 12 months.

Registry
clinicaltrials.gov
Start Date
February 28, 2018
End Date
September 19, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Caregiver-reported child age of 6-11 years
  • \< 9.5 Hours time-in-bed for sleep most days/week
  • BMI for age and gender \> 25th percentile (but no greater than 100% overweight)
  • Understanding of and ability to complete protocol
  • Self-reported caregiver age of 18 years and primary caregiver at bedtimes/wake times
  • Likes food used in the eating regulation paradigms
  • Willingness to be randomized to either treatment condition.

Exclusion Criteria

  • Diagnosable sleep disorder
  • Medication use or diagnosis of medical or psychiatric condition that may impact sleep/weight status
  • Current or planned treatment for weight control
  • Allergies or dietary restrictions that would prevent consumption of foods used in the study

Outcomes

Primary Outcomes

Change in BMIz

Time Frame: Change from baseline BMIz at 6 months

change in body mass index z-score (accounting for child age and sex)

Secondary Outcomes

  • Change in Sleep Period(Change from baseline in the sleep period at 6 months)
  • Change in Body Composition(Change from baseline percent body fat at 6 months)
  • Change in Caloric Intake(Change from baseline in caloric intake at 6 months)
  • Change in Eating in the Absence of Hunger (EAH)(Change from baseline in EAH at 6 months)
  • Change in Percent Time spent in Moderate to Vigorous Physical Activity (MVPA)(Change from baseline in MVPA at 6 months)
  • Change in Waist Circumference(Change from baseline waist circumference at 6 months)
  • Change in Insulin Resistance(Change from baseline HOMA-IR at 6 months)
  • Change in Blood Glucose Levels(Change from baseline blood glucose levels at 6 months)
  • Change in Non-HDL cholesterol (non-HDL-C)(Change from baseline in Non-HDL-C at 6 months)
  • Change in Insulin Sensitivity Index (ISI)(Change from baseline ISI at 6 months)
  • Change in Food Reinforcement(Change from baseline in food reinforcement at 6 months)

Study Sites (1)

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