Clinical trial NCT03186508: Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors-Renewal
Official title: Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors-Renewal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Sleep
Keywords: obesity prevention
sleep
behavioral intervention
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-06-14
Enrollment: 149
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. Caregiver-reported child age of 6-11 years
2. \< 9.5 Hours time-in-bed for sleep most days/week
3. BMI for age and gender \> 25th percentile (but no greater than 100% overweight)
4. Understanding of and ability to complete protocol
5. Self-reported caregiver age of 18 years and primary caregiver at bedtimes/wake times
6. Likes food used in the eating regulation paradigms
7. Willingness to be randomized to either treatment condition.

Exclusion Criteria:

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

Primary outcomes:
measure: Change in BMIz
timeFrame: Change from baseline BMIz at 6 months
Secondary outcomes:
measure: Change in Body Composition
timeFrame: Change from baseline percent body fat at 6 months
measure: Change in Waist Circumference
timeFrame: Change from baseline waist circumference at 6 months
measure: Change in Insulin Resistance
timeFrame: Change from baseline HOMA-IR at 6 months
measure: Change in Blood Glucose Levels
timeFrame: Change from baseline blood glucose levels at 6 months
measure: Change in Non-HDL cholesterol (non-HDL-C)
timeFrame: Change from baseline in Non-HDL-C at 6 months
measure: Change in Insulin Sensitivity Index (ISI)
timeFrame: Change from baseline ISI at 6 months
measure: Change in Sleep Period
timeFrame: Change from baseline in the sleep period at 6 months
measure: Change in Caloric Intake
timeFrame: Change from baseline in caloric intake at 6 months
measure: Change in Food Reinforcement
timeFrame: Change from baseline in food reinforcement at 6 months
measure: Change in Eating in the Absence of Hunger (EAH)
timeFrame: Change from baseline in EAH at 6 months
measure: Change in Percent Time spent in Moderate to Vigorous Physical Activity (MVPA)
timeFrame: Change from baseline in MVPA at 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Chantelle N Hart, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spaeth AM, Hawley NL, Raynor HA, Jelalian E, Greer A, Crouter SE, Coffman DL, Carskadon MA, Owens JA, Wing RR, Hart CN. Sleep, energy balance, and meal timing in school-aged children. Sleep Med. 2019 Aug;60:139-144. doi: 10.1016/j.sleep.2019.02.003. Epub 2019 Feb 16.