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

Primary Purpose

Obesity, Sleep

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optimize Sleep (OS)
Optimize Sleep-Plus (OS-Plus)
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring obesity prevention, sleep, behavioral intervention

Eligibility Criteria

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

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

Sites / Locations

  • Temple University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Optimize Sleep (OS)

Optimize Sleep-Plus (OS-Plus)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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 in Waist Circumference
Change in measured waist circumference
Change in Insulin Resistance
Change in the homeostatic model assessment of insulin resistance (HOMA-IR)
Change in Blood Glucose Levels
2-hour blood glucose levels measured within the context of an oral glucose tolerance test
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 in Insulin Sensitivity Index (ISI)
Insulin Sensitivity Index measured within the context of an oral glucose tolerance test
Change in Sleep Period
Wrist-worn actigraphy
Change in Caloric Intake
24-hr dietary recalls on two days used to estimate caloric intake
Change in Food Reinforcement
Measured using a validated computer activity (Behavioral Choice Task), which assesses motivation for a food reward
Change in Eating in the Absence of Hunger (EAH)
Food consumed within the context of the eating in the absence of hunger paradigm
Change in Percent Time spent in Moderate to Vigorous Physical Activity (MVPA)
Waist-worn accelerometer

Full Information

First Posted
March 31, 2017
Last Updated
August 21, 2023
Sponsor
Temple University
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03186508
Brief Title
Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors-Renewal
Official Title
Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors-Renewal
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Sleep
Keywords
obesity prevention, sleep, behavioral intervention

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Optimize Sleep (OS)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Optimize Sleep-Plus (OS-Plus)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Optimize Sleep (OS)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Optimize Sleep-Plus (OS-Plus)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in BMIz
Description
change in body mass index z-score (accounting for child age and sex)
Time Frame
Change from baseline BMIz at 6 months
Secondary Outcome Measure Information:
Title
Change in Body Composition
Description
change in body composition (% body fat) will be estimated by air displacement plethysmography (BOD POD®; Life Measurement Instruments, Concord, CA)
Time Frame
Change from baseline percent body fat at 6 months
Title
Change in Waist Circumference
Description
Change in measured waist circumference
Time Frame
Change from baseline waist circumference at 6 months
Title
Change in Insulin Resistance
Description
Change in the homeostatic model assessment of insulin resistance (HOMA-IR)
Time Frame
Change from baseline HOMA-IR at 6 months
Title
Change in Blood Glucose Levels
Description
2-hour blood glucose levels measured within the context of an oral glucose tolerance test
Time Frame
Change from baseline blood glucose levels at 6 months
Title
Change in Non-HDL cholesterol (non-HDL-C)
Description
Total cholesterol (TC) minus HDL-C, includes LDL-C, VLDL-C, and atherogenic apo-B containing lipoproteins
Time Frame
Change from baseline in Non-HDL-C at 6 months
Title
Change in Insulin Sensitivity Index (ISI)
Description
Insulin Sensitivity Index measured within the context of an oral glucose tolerance test
Time Frame
Change from baseline ISI at 6 months
Title
Change in Sleep Period
Description
Wrist-worn actigraphy
Time Frame
Change from baseline in the sleep period at 6 months
Title
Change in Caloric Intake
Description
24-hr dietary recalls on two days used to estimate caloric intake
Time Frame
Change from baseline in caloric intake at 6 months
Title
Change in Food Reinforcement
Description
Measured using a validated computer activity (Behavioral Choice Task), which assesses motivation for a food reward
Time Frame
Change from baseline in food reinforcement at 6 months
Title
Change in Eating in the Absence of Hunger (EAH)
Description
Food consumed within the context of the eating in the absence of hunger paradigm
Time Frame
Change from baseline in EAH at 6 months
Title
Change in Percent Time spent in Moderate to Vigorous Physical Activity (MVPA)
Description
Waist-worn accelerometer
Time Frame
Change from baseline in MVPA at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chantelle N Hart, PhD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19122-6091
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30905623
Citation
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.
Results Reference
derived

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

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