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Single arm intervention of a 24 week weight loss and exercise intervention.

Internet delivered, behaviorally based weight loss and exercise intervention

Weight Loss and Exercise

Kim L Dittus, MD PhD

The purpose of this study is to test the effectiveness of a behavioral weight loss and exercise intervention delivered via the internet at different cancer centers in New England. The investigators hypothesize that participants will lose 7% of their body weight. The research is being done because many women who are treated for breast cancer are overweight and treatment for breast cancer is often accompanied by weight gain. Individuals who are overweight may be more likely to have their breast cancer come back. Also women who exercise at least three hours a week seem to have less chance of their cancer coming back. The investigators hope to identify an effective weight loss and exercise intervention for breast cancer survivors that can be easily accessed by many people.

This study is designed to determine the feasibility of conducting a distantly delivered-weight loss and exercise intervention for patients who have been treated for breast cancer at three cancer centers, and to evaluate the efficacy of an Internet-based behavioral weight loss and exercise intervention delivered to overweight/obese breast cancer survivors in three New England locations.

Participants will be recruited from three New England Cancer Centers - the Vermont Cancer Center, Norris Cotton Cancer Center at Dartmouth University and the University of Massachusetts Cancer Center. Participants from each center will undergo baseline assessments that include diet assessment, body measurements (height, weight, etc), a physical activity assessment and be asked to complete a series of questionnaires.

Patients that meet the minimum requirements will be enrolled on the study. They will participate in weekly on-line "chats" about behavioral and diet modifications led by a qualified facilitator. Participants will also engage in increasing amounts of aerobic activity (typically walking) throughout the course of the intervention. The intervention lasts 6 months. At the end of those 6 months, participants will have the same assessments that were collected at baseline. Following the collection of those assessments, participants will have completed the study.

An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors

An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors: The iWEB Program

Feasibility will be determined by length of time required to obtain approval at all three sites, Numbers approached vs. numbers who participate in the study.

Efficacy will be measured using total calories and fat grams before and after the intervention

Change in Weight, BMI, body fat percentage before and after the intervention

exercise will be measured using an accelerometer before and after the intervention

Change in Il-6, hsCRP before and after the intervention

Change in Homeostatic model assessment to estimate beta cell function and insulin resistance before and after the intervention

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors	NCT01728506	Breast Cancer	Weight Loss and...	21 Years - 69 Years	University of Vermont
An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors	NCT01728506	Breast Cancer	Weight Loss and...	21 Years - 69 Years	University of Vermont

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