Expired Study
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Birmingham, Alabama 35294


Purpose:

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 summary:

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.


Criteria:

- Normoglycemic - BMI between 27-30 - Non smoker - Premenopausal - Physically untrained - Family history of obesity


Study is Available At:


Original ID:

BLKWHT (DK49779) (complet


NCT ID:

NCT00067873


Secondary ID:

R01DK049779


Study Acronym:


Brief Title:

Exercise Training in Obesity-prone Black and White Women


Official Title:

Exercise Training in Obesity-prone Black and White Women


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

21 Years


Maximum Age:

41 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Alabama at Birmingham


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

231


Enrollment Type:

Actual


Overall Contact Information

Official Name:Gary R Hunter, PhD
Principal Investigator
University of Alabama at Birmingham

Study Dates

Start Date:December 2000
Completion Date:December 2007
Completion Type:Actual
Primary Completion Date:December 2007
Primary Completion Type:Actual
Verification Date:October 2017
Last Changed Date:November 16, 2017
First Received Date:August 29, 2003

Study Outcomes

Outcome Type:Primary Outcome
Measure:Weight loss
Time Frame:6 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Change in weight after initial weight loss
Time Frame:12 months after initial weight loss (maximum 18 months after randomization)
Safety Issues:False
Description:Time of initial weight loss determined by days to reach BMI <= 25 (maximum 6 months)
Outcome Type:Secondary Outcome
Measure:Insulin sensitivity
Time Frame:6 months post baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Insulin sensitivity
Time Frame:18 months post baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in visceral fat
Time Frame:6 months post baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in visceral fat
Time Frame:18 months post baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in cholesterol
Time Frame:6 months post baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in cholesterol
Time Frame:18 months post baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in triglycerides
Time Frame:6 months post baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in triglycerides
Time Frame:18 months post baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in resting energy expenditure
Time Frame:6 months post baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in resting energy expenditure
Time Frame:18 months post baseline
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Diet
Arm Name:Diet only
Intervention Type:Behavioral
Name:Aerobic exercise
Arm Name:Diet plus aerobic exercise
Intervention Type:Behavioral
Name:Resistance exercise
Arm Name:Diet plus resistance exercise

Study Arms

Study Arm Type:Experimental
Arm Name:Diet plus resistance exercise
Study Arm Type:Experimental
Arm Name:Diet plus aerobic exercise
Study Arm Type:Active Comparator
Arm Name:Diet only

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Alabama at Birmingham
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
PMID:25606816
Reference Type:Results Reference
Citation: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.
PMID:19816413

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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