Exercise Training in Obesity-prone Black and White Women
November 16, 2017 updated by: Gary Hunter, PhD, University of Alabama at Birmingham
Overweight premenopausal Black and White women are randomized to either diet-only, diet+aerobic or diet+resistance exercise training.
Diet/behavior intervention, with or without the aerobic or resistance exercise training, will be provided throughout the 18 months of study.
Major outcomes will include measures of perceived and physiologic difficulty of exercise (cardiac, ventilatory, electromyographic responses to standardized exercise tasks); aerobic fitness; strength fitness; and spontaneous free-living energy expenditure (all derived from doubly labeled water).
The results will provide insight into the effectiveness of, and the mechanisms by which, different types of exercise training can improve physical fitness, spontaneous engagement in physical activities of daily living and, in turn, weight-loss maintenance.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Overweight premenopausal Black and White women are randomized to either diet-only, diet+aerobic or diet+resistance exercise training. Diet/behavior intervention, with or without the aerobic or resistance exercise training, will be provided throughout the 18 months of study. Major outcomes will include measures of perceived and physiologic difficulty of exercise (cardiac, ventilatory, electromyographic responses to standardized exercise tasks); aerobic fitness; strength fitness; and spontaneous free-living energy expenditure (all derived from doubly labeled water). The results will provide insight into the effectiveness of, and the mechanisms by which, different types of exercise training can improve physical fitness, spontaneous engagement in physical activities of daily living and, in turn, weight-loss maintenance.
Time of initial weight loss was defined as the time needed to reach the goal of 25 kg/m2 BMI. The women will then be evaluated one year after this time and the amount of weight gain will be determined.
Study Type
Interventional
Enrollment (Actual)
231
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
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
-
-
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
21 years to 41 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
- Normoglycemic
- BMI between 27-30
- Non smoker
- Premenopausal
- Physically untrained
- Family history of obesity
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Diet only
|
|
|
Experimental: Diet plus aerobic exercise
|
|
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Experimental: Diet plus resistance exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight loss
Time Frame: 6 months
|
6 months
|
|
|
Change in weight after initial weight loss
Time Frame: 12 months after initial weight loss (maximum 18 months after randomization)
|
Time of initial weight loss determined by days to reach BMI <= 25 (maximum 6 months)
|
12 months after initial weight loss (maximum 18 months after randomization)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Insulin sensitivity
Time Frame: 6 months post baseline
|
6 months post baseline
|
|
Insulin sensitivity
Time Frame: 18 months post baseline
|
18 months post baseline
|
|
Change in visceral fat
Time Frame: 6 months post baseline
|
6 months post baseline
|
|
Change in visceral fat
Time Frame: 18 months post baseline
|
18 months post baseline
|
|
Change in cholesterol
Time Frame: 6 months post baseline
|
6 months post baseline
|
|
Change in cholesterol
Time Frame: 18 months post baseline
|
18 months post baseline
|
|
Change in triglycerides
Time Frame: 6 months post baseline
|
6 months post baseline
|
|
Change in triglycerides
Time Frame: 18 months post baseline
|
18 months post baseline
|
|
Change in resting energy expenditure
Time Frame: 6 months post baseline
|
6 months post baseline
|
|
Change in resting energy expenditure
Time Frame: 18 months post baseline
|
18 months post baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gary R Hunter, PhD, University of Alabama at Birmingham
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hunter GR, Fisher G, Neumeier WH, Carter SJ, Plaisance EP. Exercise Training and Energy Expenditure following Weight Loss. Med Sci Sports Exerc. 2015 Sep;47(9):1950-7. doi: 10.1249/MSS.0000000000000622.
- Hunter GR, Brock DW, Byrne NM, Chandler-Laney PC, Del Corral P, Gower BA. Exercise training prevents regain of visceral fat for 1 year following weight loss. Obesity (Silver Spring). 2010 Apr;18(4):690-5. doi: 10.1038/oby.2009.316. Epub 2009 Oct 8.
- Martins C, Gower BA, Hill JO, Hunter GR. Metabolic adaptation is not a major barrier to weight-loss maintenance. Am J Clin Nutr. 2020 Sep 1;112(3):558-565. doi: 10.1093/ajcn/nqaa086.
- Brock DW, Tompkins CL, Fisher G, Hunter GR. Influence of resting energy expenditure on blood pressure is independent of body mass and a marker of sympathetic tone. Metabolism. 2012 Feb;61(2):237-41. doi: 10.1016/j.metabol.2011.06.019. Epub 2011 Aug 4.
- Brock DW, Chandler-Laney PC, Alvarez JA, Gower BA, Gaesser GA, Hunter GR. Perception of exercise difficulty predicts weight regain in formerly overweight women. Obesity (Silver Spring). 2010 May;18(5):982-6. doi: 10.1038/oby.2009.318. Epub 2009 Oct 8.
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 (Actual)
December 1, 2000
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
August 29, 2003
First Submitted That Met QC Criteria
August 29, 2003
First Posted (Estimate)
September 1, 2003
Study Record Updates
Last Update Posted (Actual)
November 20, 2017
Last Update Submitted That Met QC Criteria
November 16, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BLKWHT (DK49779) (completed)
- R01DK049779 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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