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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 : May 4, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Temple University

Tracking Information
First Submitted Date  ICMJE March 31, 2017
First Posted Date  ICMJE June 14, 2017
Last Update Posted Date May 4, 2021
Actual Study Start Date  ICMJE March 1, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2017)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2017)
  • 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 in Waist Circumference [ Time Frame: Change from baseline waist circumference at 6 months ]
    Change in measured waist circumference
  • 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 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 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 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 in Sleep Period [ Time Frame: Change from baseline in the sleep period at 6 months ]
    Wrist-worn actigraphy
  • 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 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 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 in Percent Time spent in Moderate to Vigorous Physical Activity (MVPA) [ Time Frame: Change from baseline in MVPA at 6 months ]
    Waist-worn accelerometer
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors-Renewal
Official Title  ICMJE Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors-Renewal
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Obesity
  • Sleep
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Optimize Sleep (OS)
  • 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.
    Intervention: Behavioral: Optimize Sleep-Plus (OS-Plus)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 12, 2017)
204
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ashley Greer, MPH 215-707-8998 ashley.greer@temple.edu
Contact: Chantelle N Hart, PhD 215-707-8639 chantelle.hart@temple.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03186508
Other Study ID Numbers  ICMJE R01HL092910( U.S. NIH Grant/Contract )
R01HL092910 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Temple University
Study Sponsor  ICMJE Temple University
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Chantelle N Hart, PhD Temple University
PRS Account Temple University
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP