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Exercise Training in Obesity-prone Black and White Women

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ClinicalTrials.gov Identifier: NCT00067873
Recruitment Status : Completed
First Posted : September 1, 2003
Last Update Posted : November 20, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Gary Hunter, PhD, University of Alabama at Birmingham

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Diet Behavioral: Aerobic exercise Behavioral: Resistance exercise Not Applicable

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  (Clinical Trial)
Actual Enrollment : 231 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Exercise Training in Obesity-prone Black and White Women
Actual Study Start Date : December 2000
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Diet only Behavioral: Diet
Experimental: Diet plus aerobic exercise Behavioral: Diet Behavioral: Aerobic exercise
Experimental: Diet plus resistance exercise Behavioral: Diet Behavioral: Resistance exercise



Primary Outcome Measures :
  1. Weight loss [ Time Frame: 6 months ]
  2. 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)


Secondary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: 6 months post baseline ]
  2. Insulin sensitivity [ Time Frame: 18 months post baseline ]
  3. Change in visceral fat [ Time Frame: 6 months post baseline ]
  4. Change in visceral fat [ Time Frame: 18 months post baseline ]
  5. Change in cholesterol [ Time Frame: 6 months post baseline ]
  6. Change in cholesterol [ Time Frame: 18 months post baseline ]
  7. Change in triglycerides [ Time Frame: 6 months post baseline ]
  8. Change in triglycerides [ Time Frame: 18 months post baseline ]
  9. Change in resting energy expenditure [ Time Frame: 6 months post baseline ]
  10. Change in resting energy expenditure [ Time Frame: 18 months post baseline ]


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Ages Eligible for Study:   21 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria
  • Normoglycemic
  • BMI between 27-30
  • Non smoker
  • Premenopausal
  • Physically untrained
  • Family history of obesity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067873


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Gary R Hunter, PhD University of Alabama at Birmingham

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gary Hunter, PhD, Principle Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00067873     History of Changes
Other Study ID Numbers: BLKWHT (DK49779) (completed)
R01DK049779 ( U.S. NIH Grant/Contract )
First Posted: September 1, 2003    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hydroquinone
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents