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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03186508
• Other study ID #: R01HL092910
• Secondary ID: R01HL092910
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: September 30, 2023

Study information

• Verified date: January 2024
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: September 30, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Sleep

Intervention

Behavioral:
• Optimize 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.
• Optimize 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.

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Temple University	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BMIz	change in body mass index z-score (accounting for child age and sex)	Change from baseline BMIz at 6 months
Secondary	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
Secondary	Change in Waist Circumference	Change in measured waist circumference	Change from baseline waist circumference at 6 months
Secondary	Change in Insulin Resistance	Change in the homeostatic model assessment of insulin resistance (HOMA-IR)	Change from baseline HOMA-IR at 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Sleep Period	Wrist-worn actigraphy	Change from baseline in the sleep period at 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Percent Time spent in Moderate to Vigorous Physical Activity (MVPA)	Waist-worn accelerometer	Change from baseline in MVPA at 6 months