Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Body Weight

Weight Loss

Breast Carcinoma In Situ

Carcinoma

Carcinoma in Situ

Breast Diseases

Skin Diseases

Body Weight Changes

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Participants receive one 30-minute session with the research assistant for training on how to use the SparkPeople website, and they may request additional training if needed.

Participants are instructed to self-monitor their diet at least weekly using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

All participants answer survey questions on quality of life and social cognitive theory variables and undergo anthropometric measurements at baseline, 3, and 6 months.

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I. All participants answer survey questions on quality of life and social cognitive theory variables and undergo anthropometric measurements at baseline, 3 and 6 months.

Behavioral Dietary Intervention

Use Fitbit monitor and SparkPeople web-based program

Exercise Intervention

Activity Monitoring Device

Jeanne Ferrante

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.

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.

eHealth Weight Loss Program in African American Breast Cancer Survivors

Virtual Weight Loss Program for African-American Breast Cancer Survivors

Number of eligible participants who were enrolled and randomly assigned. Feasibility is defined as \>= 75% recruitment rate.

Number of participants completing study. Feasibility will be defined as \>= 80% retention rate.

average number of days logged per week in to SparkPeople website

Average number of days per week logged in to SparkPeople website

Average number of days per week logged food into SparkPeople

Usefulness of SparkPeople website on 1 (not useful at all) to 4 (very useful) scale

Usefulness of Fitbit, rated on 1 (not useful at all) to 4 (very useful) scale

Change in waist circumference from baseline

Changes in caloric intake per day, measured by 24-hour recall

change in average number of steps per day measured using Fitbit monitor

change in fitness, measured by the 6-minute walk test

measured using Quality of Life in Adult Cancer Survivors Scale (minimum 65, maximum 257); higher scores mean worse quality of life

change in self-efficacy, eating healthy foods, measured with Health Beliefs Survey, scale range 0 (certain I cannot) to 100 (certain I can)

change in social support for healthy nutrition, measured by Health Beliefs Survey, scale range 1 (strongly disagree) to 5 (strongly agree); a higher number, e.g., 5 (strongly agree) is the more favorable outcome

National Cancer Institute (NCI)

Rutgers, The State University of New Jersey

Professor, Deparment of Family Medicine, RWJMS

This is a minimal risk study. The lifestyle behavioral modification intervention did not place participants at risk for any serious adverse events or death.

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

All participants have follow-up visits at 3, 6, 9, and 12 months to answer survey questions on quality of life and social cognitive theory variables and undergo anthropometric measurements.

Group I (SparkPeople Program)

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I. All participants have follow-up visits at 3, 6, 9, and 12 months to answer survey questions on quality of life and social cognitive theory variables and undergo anthropometric measurements.

Group II (Wait List)

Participants receive training on how to use the SparkPeople website, self-monitor their diet using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device.

Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders.

Behavioral Dietary Intervention: Use SparkPeople web-based program

Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device: Wear Fitbit activity monitoring device

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Participants receive the weight loss handout and a Fitbit activity monitor. After 6 months, participants receive the SparkPeople treatment.

Exercise Intervention: Use Fitbit monitor

Activity Monitoring Device: Wear Fitbit activity monitoring device

The overall number of participants is the number that were eligible for the study, hence it is greater than the number with results.

Recruitment Rate

Participants receive a weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.

Exercise Intervention: Use Fitbit monitor

Activity Monitoring Device: Wear Fitbit activity monitoring device

Retention Rate

Adherence to SparkPeople- Logged in

Adherence to SparkPeople- Logged Food

Acceptability of SparkPeople

Adherence to Fitbit

Acceptability of Fitbit

Change in Weight

Change in Waist Circumference

Change in Caloric Intake

Change in Physical Activity

Cardiopulmonary Fitness

Change in Quality of Life

Self-efficacy, Eating Healthy Foods

Social Support for Healthy Nutrition

Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I.

Activity Monitoring Device: Wear Fitbit activity monitoring device

Spots Global Cancer Trial Database for activity monitoring device