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

Primary Purpose

Type2 Diabetes, Sleep

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep duration 90 min
Sleep duration 45 min
Sleep timing
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type2 Diabetes

Eligibility Criteria

8 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Center for Obesity Research and Education, Temple University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Typical sleep schedule

Enhance time in bed by 90 min/night

Enhance time in bed by 45 min/night

Regularize sleep schedule

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Metabolic Measures
Blood will be drawn before and after the consumption of a glucose solution to compute an Insulin Sensitivity Index (ISI) and glucose tolerance.

Full Information

First Posted
November 29, 2016
Last Updated
October 22, 2021
Sponsor
Temple University
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1. Study Identification

Unique Protocol Identification Number
NCT02979860
Brief Title
Experimental Changes in Children's Sleep Duration and Timing: Effect on Obesity and Type 2 Diabetes Risk
Official Title
Experimental Changes in Children's Sleep Duration and Timing: Effect on Obesity and Type 2 Diabetes Risk
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
April 8, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Eligible families who provide consent/assent will be enrolled into a five week study. All families will complete assessments at baseline, two weeks and four weeks. Each assessment lasts one week and children will be asked to wear an actigraph on their wrist (to measure sleep) and an accelerometer on their hip (to measure physical activity). At the end of the week families will be scheduled for a visit at the research center first thing in the morning approximately one hour after waking and following an overnight fast. During this visit, actigraphs and accelerometers will be downloaded and data will be reviewed with families. Children will be weighed and measured for height and have their body composition assessed. To measure glucose regulation, children will first have 5 ml of blood drawn in a fasted state. They will then ingest a glucose solution (1.75 g/kg; maximum of 75 g) over 2 minutes, and blood will be drawn (1.5 ml) 120 min after the child consumes the solution. At week 4, 5 ml blood will be drawn fasting; OGTT will not be administered (see note below). Research staff will also complete one-day dietary recalls with participants at each center-based assessment to obtain information on all foods consumed over the previous 24-hour period. In addition, at the baseline assessment only, parents will complete questionnaires on basic demographic information and child sleep. It is anticipated that the total time for each assessment will take approximately 2.5-3 hours (1 hour at 4 weeks). Following eligibility confirmation at the baseline assessment, families will be randomized to one of four protocols: 1) Enhance TIB by 90 min/night; 2) Enhance TIB by 45 min/night; 3) Regularize Sleep Schedule; or 4) Typical Sleep Schedule. Continuous glucose monitoring In a voluntary subset of randomly selected children (approximately n = 4/group) 72-hour continuous glucose monitoring (CGM) will be performed. If the child and family agree to participate in CGM, they will come to the Center for an additional visit during which a disposable subcutaneous glucose-sensing device connected to a battery-operated recorder will be inserted subcutaneously (a thin tube under the surface of the skin). This sensor measures glucose every ten seconds and records an average value every five minutes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes, Sleep

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Typical sleep schedule
Arm Type
No Intervention
Arm Description
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.
Arm Title
Enhance time in bed by 90 min/night
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhance time in bed by 45 min/night
Arm Type
Experimental
Arm Description
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.
Arm Title
Regularize sleep schedule
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep duration 90 min
Intervention Description
Sleep duration: time in bed increased by 90 minutes
Intervention Type
Behavioral
Intervention Name(s)
Sleep duration 45 min
Intervention Description
Sleep duration: time in bed increased by 45 minutes
Intervention Type
Behavioral
Intervention Name(s)
Sleep timing
Intervention Description
Sleep timing: bed time kept consistent
Primary Outcome Measure Information:
Title
Insulin Resistance
Description
Fasting plasma insulin and glucose will be used to compute the homeostatic model assessment of insulin resistance (HOMA-IR).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Metabolic Measures
Description
Blood will be drawn before and after the consumption of a glucose solution to compute an Insulin Sensitivity Index (ISI) and glucose tolerance.
Time Frame
3 3-hour assessment visits
Other Pre-specified Outcome Measures:
Title
Anthropometrics
Description
Child weight will be obtained on a digital scale and height on a wall-mounted stadiometer using standard procedures and while in street clothes, without shoes. Measures will be converted to BMI, BMIz, and BMI percentile using age and sex-adjusted normative data from the CDC.
Time Frame
3 3-hour assessment visits
Title
Body Composition
Description
Youth body composition (% body fat) will be estimated by air displacement plethysmography (BOD POD®; Life Measurement Instruments, Concord, CA).
Time Frame
3 3-hour assessment visits
Title
Acceptability/Feasibility
Description
Acceptability and feasibility of each experimental approach for changing sleep will be assessed with semi-structured qualitative interviews.
Time Frame
2 3-hour assesment Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chantelle Hart, PhD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Obesity Research and Education, Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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