B-WELL: Effects of Interrupting Sedentary Time on Glycemic Control in Older Overweight and Obese Adults

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT01997021
Collaborator
(none)
25
1
6
14
1.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: US
  • Other: IW
  • Other: CW
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Interrupting Sedentary Time on Glycemic Control in Older Overweight and Obese Adults
Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Dec 31, 2014
Actual Study Completion Date :
Dec 31, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: US/IW/CW

This 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).

Other: US
US is a 5-hour intervention/condition where participants will be required to sit quietly for 5 consecutive hours.
Other Names:
  • Uninterrupted sitting
  • Other: IW
    IW is a 24-hour intervention/condition where participants interrupt sedentary time with short 1.5 minute walking bout.
    Other Names:
  • Intermittent Walking
  • Other: CW
    CW is a 24-hour intervention/condition where participants perform a 36 minute continuous walking bout and are seated the remainder of the time.
    Other Names:
  • Continuous Walking
  • Experimental: IW/US/CW

    This 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).

    Other: US
    US is a 5-hour intervention/condition where participants will be required to sit quietly for 5 consecutive hours.
    Other Names:
  • Uninterrupted sitting
  • Other: IW
    IW is a 24-hour intervention/condition where participants interrupt sedentary time with short 1.5 minute walking bout.
    Other Names:
  • Intermittent Walking
  • Other: CW
    CW is a 24-hour intervention/condition where participants perform a 36 minute continuous walking bout and are seated the remainder of the time.
    Other Names:
  • Continuous Walking
  • Experimental: IW/CW/US

    This 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).

    Other: US
    US is a 5-hour intervention/condition where participants will be required to sit quietly for 5 consecutive hours.
    Other Names:
  • Uninterrupted sitting
  • Other: IW
    IW is a 24-hour intervention/condition where participants interrupt sedentary time with short 1.5 minute walking bout.
    Other Names:
  • Intermittent Walking
  • Other: CW
    CW is a 24-hour intervention/condition where participants perform a 36 minute continuous walking bout and are seated the remainder of the time.
    Other Names:
  • Continuous Walking
  • Experimental: CW/IW/US

    This 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).

    Other: US
    US is a 5-hour intervention/condition where participants will be required to sit quietly for 5 consecutive hours.
    Other Names:
  • Uninterrupted sitting
  • Other: IW
    IW is a 24-hour intervention/condition where participants interrupt sedentary time with short 1.5 minute walking bout.
    Other Names:
  • Intermittent Walking
  • Other: CW
    CW is a 24-hour intervention/condition where participants perform a 36 minute continuous walking bout and are seated the remainder of the time.
    Other Names:
  • Continuous Walking
  • Experimental: CW/US/IW

    This 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).

    Other: US
    US is a 5-hour intervention/condition where participants will be required to sit quietly for 5 consecutive hours.
    Other Names:
  • Uninterrupted sitting
  • Other: IW
    IW is a 24-hour intervention/condition where participants interrupt sedentary time with short 1.5 minute walking bout.
    Other Names:
  • Intermittent Walking
  • Other: CW
    CW is a 24-hour intervention/condition where participants perform a 36 minute continuous walking bout and are seated the remainder of the time.
    Other Names:
  • Continuous Walking
  • Experimental: US/CW/IW

    This 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).

    Other: US
    US is a 5-hour intervention/condition where participants will be required to sit quietly for 5 consecutive hours.
    Other Names:
  • Uninterrupted sitting
  • Other: IW
    IW is a 24-hour intervention/condition where participants interrupt sedentary time with short 1.5 minute walking bout.
    Other Names:
  • Intermittent Walking
  • Other: CW
    CW is a 24-hour intervention/condition where participants perform a 36 minute continuous walking bout and are seated the remainder of the time.
    Other Names:
  • Continuous Walking
  • Outcome Measures

    Primary Outcome Measures

    1. Incremental area under the glucose curve in response to meal tolerance test (MTT) [Hourly for 5 hours after meal is consumed]

      Meal tolerance test is performed during uninterrupted sitting condition and during intermittent walking condition. Glucose area under the curve (AUC) is compared between conditions.

    2. Area under the insulin curve in response to meal tolerance test [Hourly for 5 hours after meal is consumed]

      Meal tolerance test is performed during uninterrupted sitting condition and during intermittent walking condition. Insulin AUC is compared between conditions.

    Secondary Outcome Measures

    1. Postprandial glycemia in response to meal tolerance test [Continuously for 5 hours after meal is consumed]

      Postprandial glycemia (PPG) will be measured using a continuous glucose monitor. Peak PPG, rate of change in peak PPG and duration of hyperglycemia will be calculated. Meal tolerance test will be performed during uninterrupted sitting condition and during intermittent walking condition. PPG will be compared between conditions.

    2. Insulin sensitivity [Immediately post 24 hr intermittent walking and continuous walking conditions]

      Insulin sensitivity will be measured using a hyperinsulinemic euglycemic clamp. IS will be assessed after intermittent walking condition and after continuous walk condition. IS will be compared between conditions.

    3. 24-hr Fat Oxidation [Continuously during 24 hr intermittent walking and continuous walking conditions]

      Fat oxidation will be measured in a whole room indirect calorimeter during the intermittent walking condition and during the continuous walk condition. Fat oxidation will be compared between conditions.

    4. 24-hour Glycemic variability [Continuously during 24 hr intermittent walking and continuous walking conditions]

      Glycemic variability will be measured using a continuous glucose monitor during the intermittent walking condition and during the continuous walk condition. Glycemic variability will be compared between conditions.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Colorado Denver Anschutz Medical Campus Aurora Colorado United States 80045

    Sponsors and Collaborators

    • University of Colorado, Denver

    Investigators

    • Principal Investigator: Kate Lyden, PhD, University of Colorado, Denver
    • Principal Investigator: Ed Melanson, PhD, University of Colorado, Denver

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT01997021
    Other Study ID Numbers:
    • 13-2594
    First Posted:
    Nov 27, 2013
    Last Update Posted:
    Aug 24, 2021
    Last Verified:
    Aug 1, 2021
    Keywords provided by University of Colorado, Denver
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 24, 2021