Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2018-01-01
2020-06-30
Brief Summary
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Detailed Description
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Intervention: Participants (28 healthy weight and 28 overweight/obese youth; ages 11-15 years) from an ongoing longitudinal observational study (HS-12-00446) will complete: a) an in-lab randomized crossover trial of acute metabolic responses to prolonged vs. SB interruptions; and a subset (N=12) will complete b) two 4-day continuous glucose monitoring (CGM) studies of effects of free-living habitual activity vs. SB interruptions on glucose homeostasis.
Objectives/Purpose: The overall goal is to improve metabolic outcomes by interrupting SB in youth with small bouts of exercise. The aim of this study is to investigate whether the metabolic responses to interrupting sitting are the same in a controlled lab setting and a free-living setting. This study will also try to explain why some children respond better to these short interruptions in sitting than others by using three years of physical activity, body fat, and weight trajectory data from an ongoing study (HS-12-00446).
Study Population: The study population will consist of participants currently enrolled in the Mothers and Their Children's Health (MATCH) Study (PI: Dunton; HS-12-00446; ages 11-15 years).Eligible participants will have completed 3 years of semi-annual assessments of body composition, physical activity, and dietary intake in the MATCH study.
Study Methodology: 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.
Study Arms: Participants will be assigned to receive in random order the continuous sitting test at the first visit and the sitting interruptions test on the second visit, or vice versa. The order of the free-living conditions will be the same as the in-lab condition order.
Endpoints/Outcomes: The primary endpoints are: insulin, C-peptide, and glucose area under the curve (AUC) in the in-lab experiments, and glucose AUC in the free-living experiments.
Follow-up: Study duration for those completing only the in-lab experiments is a minimum of 17 days and a maximum of 45 days to complete. For the subset of participants who are additionally completing the free-living component, the study duration is a minimum of 25 days and a maximum of 53 days.
Statistical Analyses: The populations for analyses include the full analytical dataset which consists of all randomized study participants, with the exception of those participants in the parent MATCH study who are not participating in this research study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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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
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
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
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
Interventions
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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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. good general health
3. fasting plasma glucose \<100 mg/dL
4. BMI greater than the 5th percentile
Exclusion Criteria
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
11 Years
16 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Southern California
OTHER
Responsible Party
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Britni Ryan Belcher, PhD, MPH
Assistant Professor of Preventive Medicine
Principal Investigators
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Britni R Belcher, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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University of Southern California Keck School of Medicine
Los Angeles, California, United States
Countries
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Other Identifiers
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