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OpenTrials
Completed

NCT Number: NCT00067873

Exercise Training in Obesity-prone Black and White Women

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–41 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet

Behavioral

Aerobic Exercise

Behavioral

Resistance exercise

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2000
Primary completion
2007
Study completion
2007
First posted
Sep 1, 2003
Registry last updated
Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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