Virtual Weight Loss Program in Maintaining Weight in African American Breast Cancer Survivors

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, 9, 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.

After completion of study treatment, patients from Group I are followed up for 6 months.

Inclusion Criteria:

- Patients must have evidence of histologically confirmed invasive breast cancer, stage
I, II or III, and be at least 2 years post diagnosis

- Patient is self-identified as African-American

- Patient is obese (body mass index [BMI] >= 30 kg/m^2)

- Patient is able to understand and read English

- Patient must have home internet or smartphone access

- Patient must give informed consent for this new study

Exclusion Criteria:

- Patient has a serious medical condition (e.g., stroke, liver or renal failure,
congestive heart failure, myocardial infarction or cardiac surgery in past year,
angina pectoris) that would compromise the safety of the patient or compromise the
patient's ability to complete the study, at the discretion of the investigator

- Patient has serious psychiatric condition (e.g., bipolar disorder, schizophrenia or
other psychosis, bulimia or anorexia nervosa, suicide attempt within 6 months or
current active suicidal ideation) that would compromise the patient's ability to
complete the study, at the discretion of the investigator

- Patient has severe disabilities limiting moderate physical activity, such as severe
orthopedic conditions

- Patient is planning major surgery within the next 6 months

- Patient is taking medications or supplements for weight loss currently or within the
past 3 months

- Patient has successfully lost 5% of body weight in the previous 6 months or has had
bariatric surgery

- Patient is pregnant, breastfeeding, has given birth within the last 3 months or
planning pregnancy within the next 12 months; if participant becomes pregnant during
the course of the study, she will be removed from further participation

- Patient is anticipating leaving the area within the next 12 months