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Sedentary Behavior and Health Outcomes Study (SBHO)

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ClinicalTrials.gov Identifier: NCT03153930
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : June 7, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Britni Ryan Belcher, University of Southern California

Brief Summary:
This study is a randomized crossover trial to compare the effectiveness of interrupting SB on glucose homeostasis in the lab and free-living settings. All participants (N=56) will complete one screening visit to determine eligibility, complete at fitness test, and body composition analysis by bioelectrical impedance. After 7-21 days, all participants will complete two 3-hour in-lab oral glucose tolerance tests (spaced 7-21 days apart). Prior to the in-lab OGTT visits, participants will wear an activity monitor for 7 days on the right thigh. The experimental conditions for the OGTTs will be: 1) 3-hour OGTT of continuous sitting; and 2) 3-hour OGTT with sitting interrupted every 30 minutes with 3-minutes of moderate intensity walking on a treadmill. There will be a 7-21 day washout period between the OGTT visits. In addition, a subset of participants (N=12) who meet inclusion criteria and who successfully complete both OGTT visits will complete a second randomized crossover trial in the free-living environment. The experimental conditions for the free-living components will be: 1) 4 days of habitual sedentary behaviors; and 2) 4 days of prompted short exercise breaks during times in which sedentary behaviors have exceeded 30 minutes. Participants in the free-living trial will wear an activity monitor and a continuous glucose monitor.

Condition or disease Intervention/treatment Phase
Sedentary Lifestyle Metabolic Disturbance Pediatric Obesity Physical Activity Behavioral: Walking breaks Behavioral: Sitting only Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will complete a randomized crossover study with 2 conditions: sitting continuously for 3 hours vs. interrupting sitting with 3-minute moderate intensity walking breaks every 30 minutes for 3 hours. A subset will then complete a free-living component wearing a continuous glucose monitor that will consist of habitual activity vs. interrupting periods of 30+ sedentary minutes with short activity breaks.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Metabolic Effects of Interrupting Sedentary Time in Youth In-lab and in Free-living Settings
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Sitting Only (SIT)
In-Lab (full sample): children will sit continuously for 3 hours during an OGTT Free-living (sub-sample; N=12): children will complete their habitual sedentary behaviors over 4 days; they will also wear a continuous glucose monitor
Behavioral: Sitting only
In-Lab (full sample): participants will remain seated for 3 hours during an OGTT Free-living (sub-sample; N=12): participants will perform their habitual sedentary behaviors
Other Name: Continuous sedentary time

Experimental: Walking Breaks (WALK)
In-Lab (full sample): children will be asked to walk on a treadmill every 30 minutes for 3 minute bouts during a 3 hour OGTT Free-living (sub-sample; N=12): children will be prompted with an ActivPAL vtap monitor on the right thigh to perform 3-minute walking bouts whenever sedentary time has lasted longer than 30 minutes over 4 days; they will also wear a continuous glucose monitor
Behavioral: Walking breaks
In-Lab (full sample): participants will be asked to walk on a treadmill for 3 minutes every 30 minutes at a moderate pace during a 3-hour OGTT Free-living (sub-sample; N=12): participants will be prompted via an ActivPAL vtap monitor to walk for 3 minutes every time sedentary behavior lasts longer than 30 continuous minutes
Other Name: Interrupting sedentary time




Primary Outcome Measures :
  1. In-Lab: Metabolic responses [ Time Frame: 3 hours ]
    glucose, insulin, and c-peptide area under the curve

  2. Free-living: Glucose responses [ Time Frame: 4 days ]
    glucose area under the curve

  3. Predictors of in-lab glucose responses [ Time Frame: 3 years ]
    Independent-sample t-tests will assess if mean in-lab glucose AUC differs within experimental condition by weight status (normal weight or overweight/obese). Independent-sample t-tests will assess if mean AUC values between conditions (delta AUC) differ by weight status. Structural equation models of latent growth curves will be used to assess the relationship between BMI z-score trajectories in the preceding 3 years, in-lab glucose AUC responses by experimental condition. Specifically, models will test if a) the higher the initial BMI z score (year 1), the higher the initial serum value (-10 min); b) the higher the initial BMI z score (year 1), the greater the change in serum AUC between experimental conditions; and c) the greater slope of the BMI z score change, the greater the change in serum AUC between experimental conditions.

  4. Individual variations in glucose responses in-lab [ Time Frame: 3 years ]
    Mixed-effects location scale models (MIXREGLS) will test how between-subject (BS) and within-subject (WS) variation in SB in the preceding 3 years are associated with glucose responses to in-lab SB interruptions. The predictors are average 3-year SB level and SB level at each year (variation in SB). The Stage 1 mixed-effects location scale model will examine random effects of between-subject variance (i.e., location) and of within-subject variance (i.e., scale), sex, baseline percent body fat, and baseline age. The Stage 2 model will assess how these variance sources from Stage 1 affect the delta AUC between in-lab prolonged SB and SB interruptions with regards to glucose (the WS effects).


Secondary Outcome Measures :
  1. Relationship between in-lab and free-living glucose AUC [ Time Frame: 5 days ]
    We will assess bivariate correlations between the in-lab glucose AUC and the first day of in-field glucose AUC. Linear regression will be used to estimate associations between in-lab glucose AUC responses and the first day of free-living cumulative glucose AUC. Because we will have repeated measures (4 days) of cumulative glucose AUC values in the field, mixed models will be used to assess the effects of in-lab glucose AUC on glucose responses to SB interruptions over 4 time points (day 1, 2, 3, and 4).



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Ages Eligible for Study:   11 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. current/past participant in the MATCH Study
  2. good general health
  3. fasting plasma glucose <100 mg/dL
  4. BMI greater than the 5th percentile

Exclusion Criteria:

  1. significant cardiac or pulmonary disease likely to or resulting in hypoxia or decreased perfusion
  2. evidence of impaired glucose tolerance or type 2 diabetes
  3. presence of other endocrinologic disorders leading to obesity (e.g.: Cushing Syndrome)
  4. current or past anti-psychotic drugs use that would affect metabolism
  5. non-diet treatment for hypertension or dyslipidemia
  6. precocious puberty and/or receiving androgen and estrogen therapy
  7. medication use known to affect body composition/weight

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): NCT03153930


Contacts
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Contact: Britni R Belcher, PhD, MPH 3234428225 bbelcher@usc.edu

Locations
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United States, California
University of Southern California Keck School of Medicine Recruiting
Los Angeles, California, United States, 90032
Contact: Britni R Belcher, PhD, MPH    323-442-8225    bbelcher@usc.edu   
Contact: Lissette Ramirez, MPH    323 442 7357    lissettr@usc.edu   
Sub-Investigator: Genevieve F Dunton, PhD, MPH         
Sub-Investigator: Michael Goran, PhD         
Sub-Investigator: Jimi Huh, PhD         
Sub-Investigator: Kathleen A Page, MD         
Sub-Investigator: Christina Dieli-Conwright, PhD         
Sub-Investigator: Megan Herting, PhD         
Sponsors and Collaborators
University of Southern California
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Britni R Belcher, PhD, MPH University of Southern California

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Responsible Party: Britni Ryan Belcher, Assistant Professor of Preventive Medicine, University of Southern California
ClinicalTrials.gov Identifier: NCT03153930     History of Changes
Other Study ID Numbers: 1K01DK113062 ( U.S. NIH Grant/Contract )
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not intend to share IPD with other researchers outside of our study.

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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 Britni Ryan Belcher, University of Southern California:
sedentary behavior
youth
moderating factors
metabolic outcomes
Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms