Experimental Changes in Children's Sleep Duration and Timing: Effect on Obesity and Type 2 Diabetes Risk

NCT02979860 | Completed

• 1 other identifier: 24131
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Enhancing children's sleep duration and/or timing may represent a novel approach for weight regulation and prevention of T2DM. The proposed study will assess how experimental changes in children's sleep duration and timing affect weight regulation and T2DM risk. Sixty African American children ages 8-11 years old who sleep approximately 9.5 hours or less each night will be enrolled into a 4-arm randomized controlled pilot to compare three experimental manipulations in children's sleep to a "typical sleep" (TYP) control. Experimental arms will include: 1) increase in time in bed (TIB) by 90 minutes/night; 2) increase in TIB by 45 minutes/night; or 3) consistent (CON) sleep schedule (but no change in TIB). At baseline, 2- and 4-week follow-up, participants be weighed and measured for height, have body fat assessed (bod pod), and their blood drawn (following an overnight fast). The pilot will provide important data on the potential role of sleep in combating disparities in cardiometabolic risk. Primary aims are: 1) to determine the effects of changes in sleep on changes in glucose regulation and 2) to determine the effect of changes in sleep on additional measures of glucose regulation and adiposity.

Conditions

Type2 Diabetes; Sleep

Outcome Measures

Primary Outcomes (1)

• Insulin Resistance

  Fasting plasma insulin and glucose will be used to compute the homeostatic model assessment of insulin resistance (HOMA-IR).

  4 weeks

Secondary Outcomes (1)

• Metabolic Measures

  3 3-hour assessment visits

Other Outcomes (3)

• Anthropometrics

  3 3-hour assessment visits

• Body Composition

  3 3-hour assessment visits

• Acceptability/Feasibility

  2 3-hour assesment Visit

Study Arms (4)

Typical sleep schedule

NO INTERVENTION

Children in this arm will be asked to maintain their current sleep schedule. No prescription will be provided other than to sleep how they "typically" would sleep.

Enhance time in bed by 90 min/night

EXPERIMENTAL

Sleep duration - 90 minutes: Children in this arm will be asked to get into bed and to turn their lights out 90 minutes earlier than their typical bedtime. Bedtimes and wake times will remain consistent across the 4-week experimental phase of the study.

Behavioral: Sleep duration 90 min

Enhance time in bed by 45 min/night

EXPERIMENTAL

Sleep duration - 45 minutes:Children in this arm will be asked to get into bed and to turn their lights out 45 minutes earlier than their typical bedtime. Bedtimes and wake times will remain consistent across the 4-week experimental phase of the study.

Behavioral: Sleep duration 45 min

Regularize sleep schedule

EXPERIMENTAL

Sleep timing: Children in this arm will be asked to get into bed at a consistent bedtime each night and wake at a consistent time each morning such that time in bed achieved during baseline is maintained during the 4-week experimental phase; only timing of bedtimes/wake times will be manipulated in this arm.

Behavioral: Sleep timing

Interventions

Sleep duration 90 min BEHAVIORAL

Sleep duration: time in bed increased by 90 minutes

Enhance time in bed by 90 min/night

Sleep duration 45 min BEHAVIORAL

Sleep duration: time in bed increased by 45 minutes

Enhance time in bed by 45 min/night

Sleep timing BEHAVIORAL

Sleep timing: bed time kept consistent

Regularize sleep schedule

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parent-reported child race African American/Black.
• Parent-reported child age of 8-11 years
• Less than or equal to approximately 9.5 hours time in bed (TIB; based on actigraphy and sleep diaries)
• Variability in Sleep Patterns (based on actigraphy and sleep diaries)
• BMI for age and gender \> 85th percentile (but no greater than 100% overweight)
• Self-reported parent age of 18 years, primary caretaker, and at home throughout the study (i.e., at bedtimes and wake times)
• Reported willingness to complete all study tasks, including blood draws

You may not qualify if:

• Diagnosable Sleep Disorder
• Parent-reported diagnosis of medical or psychiatric condition that may impact sleep/weight status
• Actively trying to lose weight
• Inability to Understand or Complete Protocol
• Sibling of enrolled subjects

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Center for Obesity Research and Education, Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Interventions

Sleep Duration

Intervention Hierarchy (Ancestors)

Sleep; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Chantelle 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: November 29, 2016
• First Posted: December 2, 2016
• Study Start: July 1, 2017
• Primary Completion: April 8, 2021
• Study Completion: June 30, 2021
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)