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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Diet; Behavioral: Aerobic exercise; Behavioral: Resistance exercise

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

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Gary R Hunter, PhD, University of Alabama at Birmingham

Publications and helpful links

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

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: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• 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