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

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 Overview

• Status: Completed
• Conditions: Obesity; Sleep
• Intervention / Treatment: Behavioral: Optimize Sleep (OS); Behavioral: Optimize Sleep-Plus (OS-Plus)

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashley Greer, MPH; Phone Number: 215-707-8998; Email: ashley.greer@temple.edu
• Study Contact Backup: Name: Chantelle N Hart, PhD; Phone Number: 215-707-8639; Email: chantelle.hart@temple.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19122-6091
      • Temple University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Optimize Sleep (OS); 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); 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.
Active Comparator: Optimize Sleep-Plus (OS-Plus); 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); 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Temple University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Chantelle N Hart, PhD, Temple University

Publications and helpful links

General Publications

• Spaeth AM, Hawley NL, Raynor HA, Jelalian E, Greer A, Crouter SE, Coffman DL, Carskadon MA, Owens JA, Wing RR, Hart CN. Sleep, energy balance, and meal timing in school-aged children. Sleep Med. 2019 Aug;60:139-144. doi: 10.1016/j.sleep.2019.02.003. Epub 2019 Feb 16.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: June 12, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: sleep; behavioral intervention; obesity prevention
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: R01HL092910 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No