In a randomized trial of 173 postmenopausal women aged 50-75 years, we found that a facility-based moderate-intensity (45 min/day, 5 d/wk) aerobic exercise intervention significantly decreased serum estrone and free estradiol in 3 months, that is, a decrease in two established biomarkers of postmenopausal breast cancer risk. We propose here to conduct another randomized trial to test whether a combined reduced-calorie diet plus aerobic exercise intervention could extend the reduction of serum estrogens over and beyond the degree of reduction achieved by either an exercise-alone intervention or a reduced-calorie diet alone intervention. The proposed study will test and compare the effects over one year of two lifestyle interventions in 503 postmenopausal women in a 4-arm randomized controlled trial: 1) a moderate-intensity aerobic exercise intervention (N=135); 2) a reduced-calorie diet intervention (N=135); 3) the combined exercise and reduced calorie diet interventions (N=135); and 4) control (no intervention) (N=98). The primary endpoint will be serum estrone. Secondary endpoints will include serum estradiol, free estradiol, testosterone, free testosterone, sex hormone binding protein, insulin-like growth factor IFG)-I, IGF binding protein-3, insulin, mammogram density, adiposity (weight, BMI, waist and hip; circumferences, total body fat and % fat from DXA), and Quality of Life. Women will be eligible if they are postmenopausal, aged 50-75 years, healthy, overweight or obese (BMI > 25.0 kg/m2), sedentary (less than 30 min/week in moderate activity), not using HRT X 6 mos., and nonsmokers. The calorie reduction intervention will use a modification of the Diabetes Prevention Program lifestyle behavior change program, with goals of 1200-1800 kcal/day and 7% reduction in body weight. The exercise intervention will be 45 min/day, 5 days/week, moderate-intensity aerobic (e.g. walking), combined facility and home exercise with behavioral training. Participants will be recruited through mass mailings and media placements and will undergo several screening activities. Participants will be followed for 12 months and baseline, interim, and end-of-intervention measures will be assessed and compared. Intervention adherence will be monitored via exercise and diet logs and weekly weighing. Potential adverse effects will be measured including injuries, overall bone density (DEXA), and Quality of Life.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
1R01CA105204-01A1
Application #
6824254
Study Section
Epidemiology of Cancer Study Section (EPIC)
Program Officer
Hartmuller, Virginia W
Project Start
2004-09-01
Project End
2009-08-31
Budget Start
2004-09-01
Budget End
2005-08-31
Support Year
1
Fiscal Year
2004
Total Cost
$701,672
Indirect Cost
Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
078200995
City
Seattle
State
WA
Country
United States
Zip Code
98109
Duggan, Catherine; Tapsoba, Jean de Dieu; Stanczyk, Frank et al. (2018) Long-term weight loss maintenance, sex steroid hormones, and sex hormone-binding globulin. Menopause :
Duggan, Catherine; Tapsoba, Jean de Dieu; Wang, Ching-Yun et al. (2017) Long-Term Effects of Weight Loss and Exercise on Biomarkers Associated with Angiogenesis. Cancer Epidemiol Biomarkers Prev 26:1788-1794
Duggan, Catherine; Gross, Myron D; McTiernan, Anne (2017) Diet and Exercise and Serum Markers of Oxidative Stress-Response. Cancer Prev Res (Phila) 10:487
Wang, Ching-Yun; Tapsoba, Jean De Dieu; Duggan, Catherine et al. (2016) Methods to adjust for misclassification in the quantiles for the generalized linear model with measurement error in continuous exposures. Stat Med 35:1676-88
Duggan, Catherine; Tapsoba, Jean de Dieu; Wang, Ching-Yun et al. (2016) Dietary Weight Loss and Exercise Effects on Serum Biomarkers of Angiogenesis in Overweight Postmenopausal Women: A Randomized Controlled Trial. Cancer Res 76:4226-35
Duggan, Catherine; Tapsoba, Jean de Dieu; Wang, Ching-Yun et al. (2016) Dietary Weight Loss, Exercise, and Oxidative Stress in Postmenopausal Women: A Randomized Controlled Trial. Cancer Prev Res (Phila) 9:835-843
Habermann, Nina; Makar, Karen W; Abbenhardt, Clare et al. (2015) No effect of caloric restriction or exercise on radiation repair capacity. Med Sci Sports Exerc 47:896-904
Mason, Caitlin; Xiao, Liren; Imayama, Ikuyo et al. (2015) The effects of separate and combined dietary weight loss and exercise on fasting ghrelin concentrations in overweight and obese women: a randomized controlled trial. Clin Endocrinol (Oxf) 82:369-76
Imayama, Ikuyo; Alfano, Catherine M; Mason, Caitlin et al. (2013) Weight and metabolic effects of dietary weight loss and exercise interventions in postmenopausal antidepressant medication users and non-users: a randomized controlled trial. Prev Med 57:525-32
Mason, Caitlin; Foster-Schubert, Karen E; Imayama, Ikuyo et al. (2013) History of weight cycling does not impede future weight loss or metabolic improvements in postmenopausal women. Metabolism 62:127-36

Showing the most recent 10 out of 24 publications