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Grant Details

Grant Number: 5R01CA105204-05 Interpret this number
Primary Investigator: Mctiernan, Anne
Organization: Fred Hutchinson Cancer Research Center
Project Title: Exercise, Diet, and Sex Hormones in Postmenopausal Women
Fiscal Year: 2008


Abstract

DESCRIPTION (provided by applicant): 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.



Publications

Changes in Dietary Inflammatory Index Patterns with Weight Loss in Women: A Randomized Controlled Trial.
Authors: Duggan C. , Tapsoba J.D. , Shivappa N. , Harris H.R. , H├ębert J.R. , Wang C.Y. , McTiernan A. .
Source: Cancer prevention research (Philadelphia, Pa.), 2021 01; 14(1), p. 85-94.
EPub date: 2020-08-28.
PMID: 32859616
Related Citations

Eating behaviors and weight loss outcomes in a 12-month randomized trial of diet and/or exercise intervention in postmenopausal women.
Authors: Mason C. , de Dieu Tapsoba J. , Duggan C. , Wang C.Y. , Alfano C.M. , McTiernan A. .
Source: The international journal of behavioral nutrition and physical activity, 2019-11-27; 16(1), p. 113.
EPub date: 2019-11-27.
PMID: 31775800
Related Citations

Long-term weight loss maintenance, sex steroid hormones, and sex hormone-binding globulin.
Authors: Duggan C. , Tapsoba J.D. , Stanczyk F. , Wang C.Y. , Schubert K.F. , McTiernan A. .
Source: Menopause (New York, N.Y.), 2019 04; 26(4), p. 417-422.
PMID: 30461557
Related Citations

Long-Term Effects of Weight Loss and Exercise on Biomarkers Associated with Angiogenesis.
Authors: Duggan C. , Tapsoba J.D. , Wang C.Y. , Schubert K.E.F. , McTiernan A. .
Source: Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology, 2017 12; 26(12), p. 1788-1794.
EPub date: 2017-10-17.
PMID: 29042415
Related Citations

Diet and Exercise and Serum Markers of Oxidative Stress-Response.
Authors: Duggan C. , Gross M.D. , McTiernan A. .
Source: Cancer prevention research (Philadelphia, Pa.), 2017 08; 10(8), p. 487.
EPub date: 2017-07-11.
PMID: 28698246
Related Citations

Dietary Weight Loss, Exercise, and Oxidative Stress in Postmenopausal Women: A Randomized Controlled Trial.
Authors: Duggan C. , Tapsoba J.D. , Wang C.Y. , Campbell K.L. , Foster-Schubert K. , Gross M.D. , McTiernan A. .
Source: Cancer prevention research (Philadelphia, Pa.), 2016 Nov; 9(11), p. 835-843.
PMID: 27803047
Related Citations

Dietary Weight Loss and Exercise Effects on Serum Biomarkers of Angiogenesis in Overweight Postmenopausal Women: A Randomized Controlled Trial.
Authors: Duggan C. , Tapsoba J.D. , Wang C.Y. , McTiernan A. .
Source: Cancer research, 2016-07-15; 76(14), p. 4226-35.
PMID: 27417562
Related Citations

Methods to adjust for misclassification in the quantiles for the generalized linear model with measurement error in continuous exposures.
Authors: Wang C.Y. , Tapsoba J.D. , Duggan C. , Campbell K.L. , McTiernan A. .
Source: Statistics in medicine, 2016-05-10; 35(10), p. 1676-88.
EPub date: 2015-11-22.
PMID: 26593772
Related Citations

No effect of caloric restriction or exercise on radiation repair capacity.
Authors: Habermann N. , Makar K.W. , Abbenhardt C. , Xiao L. , Wang C.Y. , Utsugi H.K. , Alfano C.M. , Campbell K.L. , Duggan C. , Foster-Schubert K.E. , et al. .
Source: Medicine and science in sports and exercise, 2015 May; 47(5), p. 896-904.
PMID: 25160845
Related Citations

The effects of separate and combined dietary weight loss and exercise on fasting ghrelin concentrations in overweight and obese women: a randomized controlled trial.
Authors: Mason C. , Xiao L. , Imayama I. , Duggan C.R. , Campbell K.L. , Kong A. , Wang C.Y. , Alfano C.M. , Blackburn G.L. , Foster-Schubert K.E. , et al. .
Source: Clinical endocrinology, 2015 Mar; 82(3), p. 369-76.
EPub date: 2014-06-12.
PMID: 24796864
Related Citations

Independent and combined effects of dietary weight loss and exercise on leukocyte telomere length in postmenopausal women.
Authors: Mason C. , Risques R.A. , Xiao L. , Duggan C.R. , Imayama I. , Campbell K.L. , Kong A. , Foster-Schubert K.E. , Wang C.Y. , Alfano C.M. , et al. .
Source: Obesity (Silver Spring, Md.), 2013 Dec; 21(12), p. E549-54.
EPub date: 2013-07-29.
PMID: 23640743
Related Citations

Weight and metabolic effects of dietary weight loss and exercise interventions in postmenopausal antidepressant medication users and non-users: a randomized controlled trial.
Authors: Imayama I. , Alfano C.M. , Mason C. , Wang C. , Duggan C. , Campbell K.L. , Kong A. , Foster-Schubert K.E. , Blackburn G.L. , Wang C.Y. , et al. .
Source: Preventive medicine, 2013 Nov; 57(5), p. 525-32.
EPub date: 2013-07-13.
PMID: 23859929
Related Citations

Effects of dietary weight loss and exercise on insulin-like growth factor-I and insulin-like growth factor-binding protein-3 in postmenopausal women: a randomized controlled trial.
Authors: Mason C. , Xiao L. , Duggan C. , Imayama I. , Foster-Schubert K.E. , Kong A. , Campbell K.L. , Wang C.Y. , Alfano C.M. , Blackburn G.L. , et al. .
Source: Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology, 2013 Aug; 22(8), p. 1457-63.
EPub date: 2013-06-11.
PMID: 23756654
Related Citations

Effects of individual and combined dietary weight loss and exercise interventions in postmenopausal women on adiponectin and leptin levels.
Authors: Abbenhardt C. , McTiernan A. , Alfano C.M. , Wener M.H. , Campbell K.L. , Duggan C. , Foster-Schubert K.E. , Kong A. , Toriola A.T. , Potter J.D. , et al. .
Source: Journal of internal medicine, 2013 Aug; 274(2), p. 163-75.
EPub date: 2013-03-29.
PMID: 23432360
Related Citations

Influence of diet, exercise, and serum vitamin d on sarcopenia in postmenopausal women.
Authors: Mason C. , Xiao L. , Imayama I. , Duggan C.R. , Foster-Schubert K.E. , Kong A. , Campbell K.L. , Wang C.Y. , Villasenor A. , Neuhouser M.L. , et al. .
Source: Medicine and science in sports and exercise, 2013 Apr; 45(4), p. 607-14.
PMID: 23190588
Related Citations

History of weight cycling does not impede future weight loss or metabolic improvements in postmenopausal women.
Authors: Mason C. , Foster-Schubert K.E. , Imayama I. , Xiao L. , Kong A. , Campbell K.L. , Duggan C.R. , Wang C.Y. , Alfano C.M. , Ulrich C.M. , et al. .
Source: Metabolism: clinical and experimental, 2013 Jan; 62(1), p. 127-36.
EPub date: 2012-08-14.
PMID: 22898251
Related Citations

Self-monitoring and eating-related behaviors are associated with 12-month weight loss in postmenopausal overweight-to-obese women.
Authors: Kong A. , Beresford S.A.A. , Alfano C.M. , Foster-Schubert K.E. , Neuhouser M.L. , Johnson D.B. , Duggan C. , Wang C.Y. , Xiao L. , Jeffery R.W. , et al. .
Source: Journal of the Academy of Nutrition and Dietetics, 2012 Sep; 112(9), p. 1428-1435.
EPub date: 2012-07-13.
PMID: 22795495
Related Citations

Effect of diet and exercise, alone or combined, on weight and body composition in overweight-to-obese postmenopausal women.
Authors: Foster-Schubert K.E. , Alfano C.M. , Duggan C.R. , Xiao L. , Campbell K.L. , Kong A. , Bain C.E. , Wang C.Y. , Blackburn G.L. , McTiernan A. .
Source: Obesity (Silver Spring, Md.), 2012 Aug; 20(8), p. 1628-38.
EPub date: 2011-04-14.
PMID: 21494229
Related Citations

Reduced-calorie dietary weight loss, exercise, and sex hormones in postmenopausal women: randomized controlled trial.
Authors: Campbell K.L. , Foster-Schubert K.E. , Alfano C.M. , Wang C.C. , Wang C.Y. , Duggan C.R. , Mason C. , Imayama I. , Kong A. , Xiao L. , et al. .
Source: Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2012-07-01; 30(19), p. 2314-26.
EPub date: 2012-05-21.
PMID: 22614972
Related Citations

Effects of a caloric restriction weight loss diet and exercise on inflammatory biomarkers in overweight/obese postmenopausal women: a randomized controlled trial.
Authors: Imayama I. , Ulrich C.M. , Alfano C.M. , Wang C. , Xiao L. , Wener M.H. , Campbell K.L. , Duggan C. , Foster-Schubert K.E. , Kong A. , et al. .
Source: Cancer research, 2012-05-01; 72(9), p. 2314-26.
PMID: 22549948
Related Citations

Adoption of diet-related self-monitoring behaviors varies by race/ethnicity, education, and baseline binge eating score among overweight-to-obese postmenopausal women in a 12-month dietary weight loss intervention.
Authors: Kong A. , Beresford S.A. , Imayama I. , Duggan C. , Alfano C.M. , Foster-Schubert K.E. , Neuhouser M.L. , Johnson D.B. , Wang C.Y. , Xiao L. , et al. .
Source: Nutrition research (New York, N.Y.), 2012 Apr; 32(4), p. 260-5.
EPub date: 2012-04-30.
PMID: 22575038
Related Citations

Associations between snacking and weight loss and nutrient intake among postmenopausal overweight to obese women in a dietary weight-loss intervention.
Authors: Kong A. , Beresford S.A. , Alfano C.M. , Foster-Schubert K.E. , Neuhouser M.L. , Johnson D.B. , Duggan C. , Wang C.Y. , Xiao L. , Bain C.E. , et al. .
Source: Journal of the American Dietetic Association, 2011 Dec; 111(12), p. 1898-903.
PMID: 22117666
Related Citations

Dietary weight loss and exercise interventions effects on quality of life in overweight/obese postmenopausal women: a randomized controlled trial.
Authors: Imayama I. , Alfano C.M. , Kong A. , Foster-Schubert K.E. , Bain C.E. , Xiao L. , Duggan C. , Wang C.Y. , Campbell K.L. , Blackburn G.L. , et al. .
Source: The international journal of behavioral nutrition and physical activity, 2011-10-25; 8, p. 118.
EPub date: 2011-10-25.
PMID: 22026966
Related Citations

Dietary weight loss and exercise effects on insulin resistance in postmenopausal women.
Authors: Mason C. , Foster-Schubert K.E. , Imayama I. , Kong A. , Xiao L. , Bain C. , Campbell K.L. , Wang C.Y. , Duggan C.R. , Ulrich C.M. , et al. .
Source: American journal of preventive medicine, 2011 Oct; 41(4), p. 366-75.
PMID: 21961463
Related Citations

Effects of weight loss on serum vitamin D in postmenopausal women.
Authors: Mason C. , Xiao L. , Imayama I. , Duggan C.R. , Bain C. , Foster-Schubert K.E. , Kong A. , Campbell K.L. , Wang C.Y. , Neuhouser M.L. , et al. .
Source: The American journal of clinical nutrition, 2011 Jul; 94(1), p. 95-103.
EPub date: 2011-05-25.
PMID: 21613554
Related Citations

Weight, physical activity, diet, and prognosis in breast and gynecologic cancers.
Authors: McTiernan A. , Irwin M. , Vongruenigen V. .
Source: Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2010-09-10; 28(26), p. 4074-80.
EPub date: 2010-07-19.
PMID: 20644095
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