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

August 20, 2021 updated by: University of Colorado, Denver

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver Anschutz Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incremental area under the glucose curve in response to meal tolerance test (MTT)
Time Frame: 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.
Hourly for 5 hours after meal is consumed
Area under the insulin curve in response to meal tolerance test
Time Frame: 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.
Hourly for 5 hours after meal is consumed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial glycemia in response to meal tolerance test
Time Frame: 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.
Continuously for 5 hours after meal is consumed
Insulin sensitivity
Time Frame: 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.
Immediately post 24 hr intermittent walking and continuous walking conditions
24-hr Fat Oxidation
Time Frame: 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.
Continuously during 24 hr intermittent walking and continuous walking conditions
24-hour Glycemic variability
Time Frame: 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.
Continuously during 24 hr intermittent walking and continuous walking conditions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ACTUAL)

December 31, 2014

Study Completion (ACTUAL)

December 31, 2014

Study Registration Dates

First Submitted

November 21, 2013

First Submitted That Met QC Criteria

November 26, 2013

First Posted (ESTIMATE)

November 27, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 24, 2021

Last Update Submitted That Met QC Criteria

August 20, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-2594

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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