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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity, Sleep

Intervention / Treatment
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* Behavioral: Optimize Sleep (OS)
* Behavioral: Optimize Sleep-Plus (OS-Plus)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Optimize Sleep (OS)<br>Optimize Sleep will focus exclusively on enhancing sleep by using effective behavioral strategies. Specific strategies to be used include: goal setting and self-monitoring, positive bedtime routines, stimulus control/sleep hygiene strategies, problem-solving regarding challenges, and review of effective strategies for relapse prevention. | Behavioral: Optimize Sleep (OS)<br>* 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.<br>|
| Active Comparator: Optimize Sleep-Plus (OS-Plus)<br>OS-Plus will focus on enhancing sleep and targeted eating (decreasing sugar-sweetened beverages and sweet and salty snack foods) and activity (increasing physical activity and decreasing TV viewing) behaviors. Specific strategies to be used include: goal setting and self-monitoring, positive bedtime routines, stimulus control/sleep hygiene strategies, problem-solving regarding challenges, and review of effective strategies for relapse prevention. | Behavioral: Optimize Sleep-Plus (OS-Plus)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMIz | change in body mass index z-score (accounting for child age and sex) | Change from baseline BMIz at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Composition | change in body composition (% body fat) will be estimated by air displacement plethysmography (BOD POD®; Life Measurement Instruments, Concord, CA) | Change from baseline percent body fat at 6 months | 
| Change in Waist Circumference | Change in measured waist circumference | Change from baseline waist circumference at 6 months | 
| Change in Insulin Resistance | Change in the homeostatic model assessment of insulin resistance (HOMA-IR) | 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 | 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 | 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 | Change from baseline ISI at 6 months | 
| Change in Sleep Period | Wrist-worn actigraphy | 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 | 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 | 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 | Change from baseline in EAH at 6 months | 
| Change in Percent Time spent in Moderate to Vigorous Physical Activity (MVPA) | Waist-worn accelerometer | Change from baseline in MVPA at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity prevention, sleep, behavioral intervention