eHealth Weight Loss Program in African American Breast Cancer Survivors

Not Applicable

Completed

Conditions: Stage IIIA Breast Cancer
Cancer Survivor
Stage IIA Breast Cancer
Stage IIIB Breast Cancer
Stage IB Breast Cancer
Stage IIIC Breast Cancer
Stage IA Breast Cancer
Stage IIB Breast Cancer
Stage 0 Breast Cancer

Interventions: Device: Activity Monitoring Device
Behavioral: Behavioral Dietary Intervention
Behavioral: Exercise Intervention

Registration Number: NCT02699983

Lead Sponsor: Rutgers, The State University of New Jersey

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 35

Inclusion Criteria

Patients must have evidence of histologically confirmed breast cancer, stage 0, I, II or III, and be at least 2 years post diagnosis
Patient is self-identified as African-American
Patient is overweight or obese (body mass index [BMI] >= 25 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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (SparkPeople program)	Exercise Intervention	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.
Group II (wait list)	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. All participants answer survey questions on quality of life and social cognitive theory variables and undergo anthropometric measurements at baseline, 3 and 6 months.
Group I (SparkPeople program)	Behavioral Dietary Intervention	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.
Group I (SparkPeople program)	Activity Monitoring Device	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.

Primary Outcome Measures

Name	Time	Method
Adherence to SparkPeople- Logged in	4-6 months after intervention	Average number of days per week logged in to SparkPeople website
Acceptability of SparkPeople	4-6 months after intervention	Usefulness of SparkPeople website on 1 (not useful at all) to 4 (very useful) scale
Recruitment Rate	12 months	Number of eligible participants who were enrolled and randomly assigned. Feasibility is defined as \>= 75% recruitment rate.
Adherence to Fitbit	4-6 months after intervention	average days used Fitbit per week
Adherence to SparkPeople- Logged Food	4-6 months after intervention	Average number of days per week logged food into SparkPeople
Retention Rate	6 months	Number of participants completing study. Feasibility will be defined as \>= 80% retention rate.
Acceptability of Fitbit	4-6 months after intervention	Usefulness of Fitbit, rated on 1 (not useful at all) to 4 (very useful) scale

Secondary Outcome Measures

Name	Time	Method
Change in Weight	baseline and 6 months	Change in weight from baseline
Change in Waist Circumference	baseline and 6 months	Change in waist circumference from baseline
Change in Quality of Life	baseline and 6 months	measured using Quality of Life in Adult Cancer Survivors Scale (minimum 65, maximum 257); higher scores mean worse quality of life
Change in Caloric Intake	baseline and 6 months	Changes in caloric intake per day, measured by 24-hour recall
Change in Physical Activity	baseline and 6 months	change in average number of steps per day measured using Fitbit monitor
Cardiopulmonary Fitness	baseline and 6 months	change in fitness, measured by the 6-minute walk test
Self-efficacy, Eating Healthy Foods	baseline and 6 months	change in self-efficacy, eating healthy foods, measured with Health Beliefs Survey, scale range 0 (certain I cannot) to 100 (certain I can)
Social Support for Healthy Nutrition	baseline and 6 months	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