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

October 24, 2024 updated by: Temple University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
149

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19122-6091
        • Temple University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Optimize Sleep (OS)
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)
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.
Active Comparator: Optimize Sleep-Plus (OS-Plus)
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)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in BMIz
Time Frame: Change from baseline BMIz at 6 months
change in body mass index z-score (accounting for child age and sex)
Change from baseline BMIz at 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Body Composition
Time Frame: Change from baseline percent body fat at 6 months
change in body composition (% body fat) will be estimated by air displacement plethysmography (BOD POD®; Life Measurement Instruments, Concord, CA)
Change from baseline percent body fat at 6 months
Change in Waist Circumference
Time Frame: Change from baseline waist circumference at 6 months
Change in measured waist circumference
Change from baseline waist circumference at 6 months
Change in Insulin Resistance
Time Frame: Change from baseline HOMA-IR at 6 months
Change in the homeostatic model assessment of insulin resistance (HOMA-IR)
Change from baseline HOMA-IR at 6 months
Change in Blood Glucose Levels
Time Frame: Change from baseline blood glucose levels at 6 months
2-hour blood glucose levels measured within the context of an oral glucose tolerance test
Change from baseline blood glucose levels at 6 months
Change in Non-HDL cholesterol (non-HDL-C)
Time Frame: Change from baseline in Non-HDL-C at 6 months
Total cholesterol (TC) minus HDL-C, includes LDL-C, VLDL-C, and atherogenic apo-B containing lipoproteins
Change from baseline in Non-HDL-C at 6 months
Change in Insulin Sensitivity Index (ISI)
Time Frame: Change from baseline ISI at 6 months
Insulin Sensitivity Index measured within the context of an oral glucose tolerance test
Change from baseline ISI at 6 months
Change in Sleep Period
Time Frame: Change from baseline in the sleep period at 6 months
Wrist-worn actigraphy
Change from baseline in the sleep period at 6 months
Change in Caloric Intake
Time Frame: Change from baseline in caloric intake at 6 months
24-hr dietary recalls on two days used to estimate caloric intake
Change from baseline in caloric intake at 6 months
Change in Food Reinforcement
Time Frame: Change from baseline in food reinforcement at 6 months
Measured using a validated computer activity (Behavioral Choice Task), which assesses motivation for a food reward
Change from baseline in food reinforcement at 6 months
Change in Eating in the Absence of Hunger (EAH)
Time Frame: Change from baseline in EAH at 6 months
Food consumed within the context of the eating in the absence of hunger paradigm
Change from baseline in EAH at 6 months
Change in Percent Time spent in Moderate to Vigorous Physical Activity (MVPA)
Time Frame: Change from baseline in MVPA at 6 months
Waist-worn accelerometer
Change from baseline in MVPA at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Temple University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chantelle N Hart, PhD, Temple University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 19, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01HL092910 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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