Effects of Interrupting Sedentary Time on Glycemic Control in Older Overweight and Obese Adults
B-WELL
1 other identifier
interventional
25
1 country
1
Brief Summary
Increasing physical activity in older adults has important implications for treating obesity related metabolic conditions, however the interaction of aging- and obesity-related declines in physical function may make adding structured exercise particularly challenging for this group. Given these challenges, an alternative prescription to traditional structured exercise, may be short bouts of intermittent walking scattered throughout the day - this may be an effective strategy to increase physical activity, reduce sedentary behavior, and improve glycemic control in overweight/obese older adults. The purpose of this project is to determine how interrupting sedentary time with short bouts of moderate intensity walking affects important metabolic outcomes in older, overweight adults. It would also be of interest to compare the effects of short, frequent interruptions in sedentary behavior to a traditional exercise prescription (continuous 30 min walking bout) on metabolic outcomes (e.g., glycemic control, insulin sensitivity, and 24 h fat oxidation). Thus, the overall aims of the proposed research are to 1) Determine the effect of performing short bouts of moderate-intensity intermittent walking (IW) on glucose and insulin metabolism compared to uninterrupted sitting (US) in older overweight and obese adults. 2) To compare the effects of interrupting sedentary time (IW) vs. a traditional exercise prescription (continuous 30 m walk (CW)) on metabolism. The investigators hypothesize that interrupting sedentary time with intermittent walking will improve glucose and insulin metabolism compared to uninterrupted sitting and it will be as effective at improving metabolism as a single continuous 30 min walk.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 21, 2013
CompletedFirst Posted
Study publicly available on registry
November 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2014
CompletedAugust 24, 2021
August 1, 2021
1.2 years
November 21, 2013
August 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incremental area under the glucose curve in response to meal tolerance test (MTT)
Meal tolerance test is performed during uninterrupted sitting condition and during intermittent walking condition. Glucose area under the curve (AUC) is compared between conditions.
Hourly for 5 hours after meal is consumed
Area under the insulin curve in response to meal tolerance test
Meal tolerance test is performed during uninterrupted sitting condition and during intermittent walking condition. Insulin AUC is compared between conditions.
Hourly for 5 hours after meal is consumed
Secondary Outcomes (4)
Postprandial glycemia in response to meal tolerance test
Continuously for 5 hours after meal is consumed
Insulin sensitivity
Immediately post 24 hr intermittent walking and continuous walking conditions
24-hr Fat Oxidation
Continuously during 24 hr intermittent walking and continuous walking conditions
24-hour Glycemic variability
Continuously during 24 hr intermittent walking and continuous walking conditions
Study Arms (6)
US/IW/CW
EXPERIMENTALThis is a 3 arm crossover design. Arm US/IW/CW corresponds to the group of participants randomized to uninterrupted sitting (US) first, then Intermittent Walking (IW) and then continuous walk (CW).
IW/US/CW
EXPERIMENTALThis is a 3 arm crossover design. Arm IW/US/CW corresponds to the group of participants randomized to Intermittent Walking (IW) first, then uninterrupted sitting (US), and then continuous walk (CW).
IW/CW/US
EXPERIMENTALThis is a 3 arm crossover design. Arm IW/CW/US corresponds to the group of participants randomized to Intermittent Walking (IW) first, then Continuous Walk (CW) and then Uninterrupted Sitting (US).
CW/IW/US
EXPERIMENTALThis is a 3 arm crossover design. Arm CW/IW/US corresponds to the group of participants randomized to Continuous Walk (CW) first, then Intermittent Walking (IW) and then Uninterrupted Sitting (US).
CW/US/IW
EXPERIMENTALThis is a 3 arm crossover design. Arm CW/IW/US corresponds to the group of participants randomized to Continuous Walk (CW) first, then Uninterrupted Sitting (US), and then Intermittent Walking (IW).
US/CW/IW
EXPERIMENTALThis is a 3 arm crossover design. Arm US/CW/IW corresponds to the group of participants randomized to Uninterrupted Sitting (US) first, then Continuous Walk (CW), and then Intermittent Walking (IW).
Interventions
US is a 5-hour intervention/condition where participants will be required to sit quietly for 5 consecutive hours.
IW is a 24-hour intervention/condition where participants interrupt sedentary time with short 1.5 minute walking bout.
CW is a 24-hour intervention/condition where participants perform a 36 minute continuous walking bout and are seated the remainder of the time.
Eligibility Criteria
You may qualify if:
- Aged 60-85 yr • BMI 25-35 kg.m-2
- Non-exercisers (\<150 m/wk of moderate intensity exercise)
- Sedentary (\>60% of waking day sedentary)
- Able to walk on a treadmill for 36 continuous minutes at a pace of at least 2.0 mph
You may not qualify if:
- Self-reported acute or chronic disease (e.g. diabetes, heart disease, thyroid disease)
- Fasting plasma glucose ≥ 126 mg/dl - participants will not be excluded if they an abnormal post prandial glucose levels (e.g. glucose ≥ 200 mg/dl) following the MTT's.
- Tobacco use (cigarettes, cigars, or chewing tobacco) within the past 6 months
- Females who previously used (\> 6 months) or are currently using any formulation of estrogen-based hormone therapy (e.g., oral Premarin, transdermal 17-estradiol, selective estrogen receptor modulators).
- Resting diastolic blood pressure \> 100 mm mercury or resting systolic blood pressure \> 160 mm mercury
- Contra-indications to exercise (e.g. orthopedic limitations)
- Unable to walk on a treadmill for 36 continuous minutes at a pace of at least 2.0 mph
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kate Lyden, PhD
University of Colorado, Denver
- PRINCIPAL INVESTIGATOR
Ed Melanson, PhD
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2013
First Posted
November 27, 2013
Study Start
November 1, 2013
Primary Completion
December 31, 2014
Study Completion
December 31, 2014
Last Updated
August 24, 2021
Record last verified: 2021-08