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

Temple University149 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

149

Interventions

Optimize Sleep (OS)BEHAVIORAL

All children will receive 8 sessions during active treatment: two in-person weekly, three in-person biweekly, and 3 monthly sessions conducted by phone. All families will be asked to complete 3 "sleep challenges" (at weeks 8, 16, and 20). During maintenance, families will continue with monthly phone contact.

Optimize Sleep-Plus (OS-Plus)BEHAVIORAL

Eligibility

Sex: ALLMin age: 6 YearsMax age: 11 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in BMIz

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

Time frame: Change from baseline BMIz at 6 months

Secondary Outcomes

Change in Body Composition

change in body composition (% body fat) will be estimated by air displacement plethysmography (BOD POD®; Life Measurement Instruments, Concord, CA)

Time frame: Change from baseline percent body fat at 6 months

Change in Waist Circumference

Change in measured waist circumference

Time frame: Change from baseline waist circumference at 6 months

Change in Insulin Resistance

Change in the homeostatic model assessment of insulin resistance (HOMA-IR)

Time frame: Change from baseline HOMA-IR at 6 months

Change in Blood Glucose Levels

2-hour blood glucose levels measured within the context of an oral glucose tolerance test

Time frame: Change from baseline blood glucose levels at 6 months

Change in Non-HDL cholesterol (non-HDL-C)

Total cholesterol (TC) minus HDL-C, includes LDL-C, VLDL-C, and atherogenic apo-B containing lipoproteins

Time frame: Change from baseline in Non-HDL-C at 6 months

Change in Insulin Sensitivity Index (ISI)

Insulin Sensitivity Index measured within the context of an oral glucose tolerance test

Time frame: Change from baseline ISI at 6 months

Change in Sleep Period

Wrist-worn actigraphy

Time frame: Change from baseline in the sleep period at 6 months

Change in Caloric Intake

24-hr dietary recalls on two days used to estimate caloric intake

Time frame: Change from baseline in caloric intake at 6 months

Change in Food Reinforcement

Measured using a validated computer activity (Behavioral Choice Task), which assesses motivation for a food reward

Time frame: Change from baseline in food reinforcement at 6 months

Change in Eating in the Absence of Hunger (EAH)

Food consumed within the context of the eating in the absence of hunger paradigm

Time frame: Change from baseline in EAH at 6 months

Change in Percent Time spent in Moderate to Vigorous Physical Activity (MVPA)

Waist-worn accelerometer

Time frame: Change from baseline in MVPA at 6 months