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

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ClinicalTrials.gov Identifier: NCT03186508
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : June 19, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Temple University

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 8-11 years old who are 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.

Condition or disease Intervention/treatment Phase
Obesity Sleep Behavioral: Optimize Sleep (OS) Behavioral: Optimize Sleep-Plus (OS-Plus) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors-Renewal
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. Change in Waist Circumference [ Time Frame: Change from baseline waist circumference at 6 months ]
    Change in measured waist circumference

  3. 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)

  4. 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

  5. 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

  6. 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

  7. Change in Sleep Period [ Time Frame: Change from baseline in the sleep period at 6 months ]
    Wrist-worn actigraphy

  8. 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

  9. 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

  10. 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

  11. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Caregiver-reported child age of 8-11 years
  2. < 9.5 Hours time-in-bed for sleep most days/week
  3. Self-reported race as African-American/Black
  4. BMI for age and gender > 10th percentile (but no greater than 100% overweight)
  5. Understanding of and ability to complete protocol
  6. Self-reported caregiver age of 18 years and primary caregiver at bedtimes/wake times
  7. Likes food used in the eating regulation paradigms
  8. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03186508


Contacts
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Contact: Ashley Greer, MPH 215-707-8998 ashley.greer@temple.edu
Contact: Chantelle N Hart, PhD 215-707-8639 chantelle.hart@temple.edu

Locations
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United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19122-6091
Contact: Ashley Greer, MPH    215-707-5782    ashley.greer@temple.edu   
Contact: Chantelle Hart    2157078998    chantelle.hart@temple.edu   
Sponsors and Collaborators
Temple University
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Chantelle N Hart, PhD Temple University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT03186508     History of Changes
Other Study ID Numbers: R01HL092910 ( U.S. NIH Grant/Contract )
R01HL092910 ( U.S. NIH Grant/Contract )
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Temple University:
obesity prevention
sleep
behavioral intervention
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms