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

NCT03186508 | Completed DMC

• 1 other identifier: R01HL092910
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Sleep

Keywords

obesity prevention; sleep; behavioral intervention

Outcome Measures

Primary Outcomes (1)

• Change in BMIz

  change in body mass index z-score (accounting for child age and sex)

  Change from baseline BMIz at 6 months

Secondary Outcomes (11)

• Change in Body Composition

  Change from baseline percent body fat at 6 months

• Change in Waist Circumference

  Change from baseline waist circumference at 6 months

• Change in Insulin Resistance

  Change from baseline HOMA-IR at 6 months

• Change in Blood Glucose Levels

  Change from baseline blood glucose levels at 6 months

• Change in Non-HDL cholesterol (non-HDL-C)

  Change from baseline in Non-HDL-C at 6 months

Study Arms (2)

Optimize Sleep (OS)

ACTIVE COMPARATOR

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)

Optimize Sleep-Plus (OS-Plus)

ACTIVE COMPARATOR

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)

Interventions

Optimize Sleep (OS) BEHAVIORAL

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 (OS)

Optimize Sleep-Plus (OS-Plus) BEHAVIORAL

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)

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Temple University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19122-6091, United States

Location

Related Publications (1)

• 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.

  PMID: 30905623 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chantelle N Hart, PhD

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: June 14, 2017
• Study Start: February 28, 2018
• Primary Completion: March 1, 2023
• Study Completion: September 19, 2023
• Last Updated: October 28, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)