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Spots Global Cancer Trial Database for eHealth Weight Loss Program in African American Breast Cancer Survivors

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Trial Identification

Brief Title: eHealth Weight Loss Program in African American Breast Cancer Survivors

Official Title: Virtual Weight Loss Program for African-American Breast Cancer Survivors

Study ID: NCT02699983

Study Description

Brief Summary: This randomized pilot clinical trial studies how well a virtual weight loss program (SparkPeople) works in helping female African American breast cancer survivors maintain a healthy weight. Many patients with breast cancer are overweight or gain weight after diagnosis. SparkPeople is a free web-based weight loss program that features educational and motivational articles and videos, self-monitoring tools, incentives, social support communities (including discussion forums, teams, challenges, and expert blogs), and options for content to be delivered to members' email. It is a comprehensive program that includes advice on diet, physical activity, and behavioral strategies (such as self-monitoring diet and exercise), and emphasizes safe weight loss and receiving medical attention regularly when needed. A web-based program such as SparkPeople may help breast cancer survivors maintain a healthy weight, which may reduce the risk of cancer returning and patient fatigue, and improve patient quality of life.

Detailed Description: PRIMARY OBJECTIVES: I. Determine feasibility of using a free online commercial weight loss program (SparkPeople) in African-American (AA) breast cancer survivors, as measured by: 1) Accrual: percent (%) patients recruited and completing baseline assessments; 2) Study retention: % patients completing 6 month follow-up assessment; 3) Intervention adherence and sustainability (measured at 3, 6, 12 months): a) use of website- number of log-ins, time spent, and use of features such as food diaries, joining teams, posting on message boards (provided by SparkPeople); b) use of Fitbit monitor- % patients who wore the monitor and synced data; c) satisfaction (e.g., ease of use of website, usefulness of content, extra training and support needed) and barriers to participation (e.g., lack of computer access, lack of skills, time, interest, etc.). SECONDARY OBJECTIVES: I. Collect preliminary data on effect sizes of changes in our outcomes and potential mediators associated with the use of the online weight loss program. OUTLINE: Patients are randomized to 1 of 2 groups. All patients receive a handout of their personalized goals for weight loss, diet, and physical activity, with instructions to proceed slowly and as tolerated. Patients also wear a Fitbit monitoring device to monitor physical activity levels daily. GROUP I: Patients receive one 30-minute session with the research assistant for training on how to use the SparkPeople website, and may request additional training if needed. Patients are instructed to self-monitor their diet at least weekly using SparkPeople and physical activity levels daily using the Fitbit monitoring device, which integrates with the SparkPeople program. Patients receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Patients then enter the maintenance phase for an additional 3 months without reminders. GROUP II: Patients receive the weight loss handout and a Fitbit health monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.

Keywords

Eligibility

Minimum Age: 21 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States

Contact Details

Name: Jeanne Ferrante

Affiliation: Rutgers Cancer Institute of New Jersey

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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