cancer survival through weight loss and exercise

Conditions: Breast Cancer Survivors

Summary: to test the effectiveness and feasibility of intensive motivational, behavior modifying intervention aimed at improving physical activity and dietary habits to produce at least 7% weight loss in women with a history of breast cancer in a community health setting.

this study will be divided into two phases (phase i and ii) that will differ by the intensity of motivational intervention. in phase i, participants will receive 6 months of intensive weekly group-based or telephone-based motivational, behavior modifying intervention aimed at improving physical activity levels and dietary habits. phase ii will be an additional 6 months of monthly individualized motivational intervention in order to attain and maintain at least 7% body weight loss. all participants will attend an orientation, 2 run-in sessions, and a baseline assessment prior to the intervention. participants will then be assigned to either the group based intervention or telephone intervention. the first 30 participants will enter into the group-based intervention and the second 30 will enter into the telephone-based intervention. follow-up visits will be completed at the end of phase i (week 25) and phase ii (week 50). up to 60 women with a previous history of breast cancer will participate in this study.

Eligibility criteria:
inclusion criteria: * women between the ages of 30 and 75. * positive history of breast cancer treatment completed at least 2 months but no longer than 36 months prior to randomization. * bmi ≥ 25 kg/m2 and ≤ 45 kg/m2 * not involved in regular physical activity or weight loss management programs. * stage i, ii or iiia breast cancer with good prognosis. exclusion criteria: * presence of any co-morbidities including cardiovascular disease or diabetes * fasting triglycerides \> 500 mg/dl. * consume more than 14 alcoholic beverages per week. * a history of drug abuse, or excess alcohol consumption (40g/day)6. * currently dieting or engaging in any activity with the goal of losing weight. * significant intentional weight loss in the past year (\> 50 lbs in the past year) or current use of weight loss medications. * history of gastrointestinal bypass or other bariatric surgery in the last 3 years. * pregnant or plan on becoming pregnant in the next 12 months. * factors that may limit adherence to intervention or affect conduct of the trial. * unable or unwilling to communicate with staff, to provide written informed consent, or accept the randomized assignment. * failure to complete run-in and baseline testing. * lack support from health care provider or family members. * other temporary intervening event, such as sick spouse, bereavement, or recent move. * any other medical condition or disease that is life threatening or that can interfere with or be aggravated by exercise. * current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder. * any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study.

Keywords: breast cancer weight loss group intervention telephone intervention