NCT03186508

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

Completed NA Last updated 28 October 2024

What this trial tests

NA trial testing Optimize Sleep (OS) in Obesity in 149 participants. Completed in 19 September 2023.

Timeline

28 February 2018

Primary endpoint
1 March 2023

19 September 2023

Quick facts

Lead sponsor	Temple University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	149
Start date	28 February 2018
Primary completion	1 March 2023
Estimated completion	19 September 2023
Sites	1 location across United States

Drugs / interventions tested

• Optimize Sleep (OS)
• Optimize Sleep-Plus (OS-Plus)

Conditions studied

• Obesity — all drugs for Obesity →
• Sleep — all drugs for Sleep →

Sponsor

Temple University

Who can join

Adults 6 to 11, any sex, with Obesity or Sleep. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions to prevent obesity in children aged 5 to 11 years old.
   Spiga F, Davies AL, Tomlinson E, Moore TH, et al · · 2024 · cited 40× · PMID 38763517 · DOI 10.1002/14651858.cd015328.pub2
2. Sleep, energy balance, and meal timing in school-aged children.
   Spaeth AM, Hawley NL, Raynor HA, Jelalian E, et al · · 2019 · cited 33× · PMID 30905623 · DOI 10.1016/j.sleep.2019.02.003