Clinical trial NCT00067873: Exercise Training in Obesity-prone Black and White Women
Official title: Exercise Training in Obesity-prone Black and White Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2003-09-01
Enrollment: 231
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: * Normoglycemic
* BMI between 27-30
* Non smoker
* Premenopausal
* Physically untrained
* Family history of obesity

Primary outcomes:
measure: Weight loss
timeFrame: 6 months
measure: Change in weight after initial weight loss
timeFrame: 12 months after initial weight loss (maximum 18 months after randomization)
Secondary outcomes:
measure: Insulin sensitivity
timeFrame: 6 months post baseline
measure: Insulin sensitivity
timeFrame: 18 months post baseline
measure: Change in visceral fat
timeFrame: 6 months post baseline
measure: Change in visceral fat
timeFrame: 18 months post baseline
measure: Change in cholesterol
timeFrame: 6 months post baseline
measure: Change in cholesterol
timeFrame: 18 months post baseline
measure: Change in triglycerides
timeFrame: 6 months post baseline
measure: Change in triglycerides
timeFrame: 18 months post baseline
measure: Change in resting energy expenditure
timeFrame: 6 months post baseline
measure: Change in resting energy expenditure
timeFrame: 18 months post baseline
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Gary R Hunter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
citation: 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.
citation: 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.