Obesity, Sleep
Conditions
Keywords
obesity prevention, sleep, behavioral intervention
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.
Interventions
BEHAVIORALOptimize Sleep (OS)
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.
BEHAVIORALOptimize Sleep-Plus (OS-Plus)
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Temple University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in BMIz | Change from baseline BMIz at 6 months | change in body mass index z-score (accounting for child age and sex) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Waist Circumference | Change from baseline waist circumference at 6 months | Change in measured waist circumference |
| Change in Insulin Resistance | Change from baseline HOMA-IR at 6 months | Change in the homeostatic model assessment of insulin resistance (HOMA-IR) |
| Change in Blood Glucose Levels | Change from baseline blood glucose levels at 6 months | 2-hour blood glucose levels measured within the context of an oral glucose tolerance test |
| Change in Non-HDL cholesterol (non-HDL-C) | Change from baseline in Non-HDL-C at 6 months | Total cholesterol (TC) minus HDL-C, includes LDL-C, VLDL-C, and atherogenic apo-B containing lipoproteins |
| Change in Insulin Sensitivity Index (ISI) | Change from baseline ISI at 6 months | Insulin Sensitivity Index measured within the context of an oral glucose tolerance test |
| Change in Body Composition | Change from baseline percent body fat at 6 months | change in body composition (% body fat) will be estimated by air displacement plethysmography (BOD POD®; Life Measurement Instruments, Concord, CA) |
| Change in Caloric Intake | Change from baseline in caloric intake at 6 months | 24-hr dietary recalls on two days used to estimate caloric intake |
| Change in Food Reinforcement | Change from baseline in food reinforcement at 6 months | Measured using a validated computer activity (Behavioral Choice Task), which assesses motivation for a food reward |
| Change in Eating in the Absence of Hunger (EAH) | Change from baseline in EAH at 6 months | Food consumed within the context of the eating in the absence of hunger paradigm |
| Change in Percent Time spent in Moderate to Vigorous Physical Activity (MVPA) | Change from baseline in MVPA at 6 months | Waist-worn accelerometer |
| Change in Sleep Period | Change from baseline in the sleep period at 6 months | Wrist-worn actigraphy |
Countries
United States
Outcome results
None listed