Temple University
Philadelphia, Pennsylvania, 19122-6091, United States
NCT Number: NCT03186508
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.
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Notify Me6 year–11 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19122-6091, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Change from baseline BMIz at 6 months
change in body mass index z-score (accounting for child age and sex)
Time frame: 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)
Time frame: Change from baseline waist circumference at 6 months
Change in measured waist circumference
Time frame: Change from baseline HOMA-IR at 6 months
Change in the homeostatic model assessment of insulin resistance (HOMA-IR)
Time frame: Change from baseline blood glucose levels at 6 months
2-hour blood glucose levels measured within the context of an oral glucose tolerance test
Time frame: 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
Time frame: Change from baseline ISI at 6 months
Insulin Sensitivity Index measured within the context of an oral glucose tolerance test
Time frame: Change from baseline in the sleep period at 6 months
Wrist-worn actigraphy
Time frame: Change from baseline in caloric intake at 6 months
24-hr dietary recalls on two days used to estimate caloric intake
Time frame: 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
Time frame: Change from baseline in EAH at 6 months
Food consumed within the context of the eating in the absence of hunger paradigm
Time frame: Change from baseline in MVPA at 6 months
Waist-worn accelerometer
Temple University
Other
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