Exercise Training in Obesity-prone Black and White Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Exercise Training in Obesity-prone Black and White Women

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Diet
* Behavioral: Aerobic exercise
* Behavioral: Resistance exercise


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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 41 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diet only<br> | Behavioral: Diet<br> <br> |
| Experimental: Diet plus aerobic exercise<br> | Behavioral: Diet<br> <br> Behavioral: Aerobic exercise<br> <br> |
| Experimental: Diet plus resistance exercise<br> | Behavioral: Diet<br> <br> Behavioral: Resistance exercise<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss |  | 6 months | 
| Change in weight after initial weight loss | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity |  | 6 months post baseline | 
| Insulin sensitivity |  | 18 months post baseline | 
| Change in visceral fat |  | 6 months post baseline | 
| Change in visceral fat |  | 18 months post baseline | 
| Change in cholesterol |  | 6 months post baseline | 
| Change in cholesterol |  | 18 months post baseline | 
| Change in triglycerides |  | 6 months post baseline | 
| Change in triglycerides |  | 18 months post baseline | 
| Change in resting energy expenditure |  | 6 months post baseline | 
| Change in resting energy expenditure |  | 18 months post baseline |