Clinical trial NCT02699983: eHealth Weight Loss Program in African American Breast Cancer Survivors
Official title: Virtual Weight Loss Program for African-American Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivor
Stage IA Breast Cancer
Stage IB Breast Cancer
Stage IIA Breast Cancer
Stage IIB Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage 0 Breast Cancer
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-03-07
Enrollment: 35
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment Rate
timeFrame: 12 months
measure: Retention Rate
timeFrame: 6 months
measure: Adherence to SparkPeople- Logged in
timeFrame: 0-3 months after intervention
measure: Adherence to SparkPeople- Logged in
timeFrame: 4-6 months after intervention
measure: Adherence to SparkPeople- Logged Food
timeFrame: 0-3 months after intervention
measure: Adherence to SparkPeople- Logged Food
timeFrame: 4-6 months after intervention
measure: Acceptability of SparkPeople
timeFrame: 0-3 months after intervention
measure: Acceptability of SparkPeople
timeFrame: 4-6 months after intervention
measure: Adherence to Fitbit
timeFrame: 0-3 months after intervention
measure: Adherence to Fitbit
timeFrame: 4-6 months after intervention
measure: Acceptability of Fitbit
timeFrame: 0-3 months after intervention
measure: Acceptability of Fitbit
timeFrame: 4-6 months after intervention
Secondary outcomes:
measure: Change in Weight
timeFrame: baseline and 3 months
measure: Change in Weight
timeFrame: baseline and 6 months
measure: Change in Waist Circumference
timeFrame: baseline and 3 months
measure: Change in Waist Circumference
timeFrame: baseline and 6 months
measure: Change in Caloric Intake
timeFrame: baseline and 3 months
measure: Change in Caloric Intake
timeFrame: baseline and 6 months
measure: Change in Physical Activity
timeFrame: baseline and 3 months
measure: Change in Physical Activity
timeFrame: baseline and 6 months
measure: Cardiopulmonary Fitness
timeFrame: baseline and 3 months
measure: Cardiopulmonary Fitness
timeFrame: baseline and 6 months
measure: Change in Quality of Life
timeFrame: baseline and 3 months
measure: Change in Quality of Life
timeFrame: baseline and 6 months
measure: Self-efficacy, Eating Healthy Foods
timeFrame: baseline and 3 months
measure: Self-efficacy, Eating Healthy Foods
timeFrame: baseline and 6 months
measure: Social Support for Healthy Nutrition
timeFrame: baseline and 3 months
measure: Social Support for Healthy Nutrition
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Jeanne Ferrante
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferrante JM, Devine KA, Bator A, Rodgers A, Ohman-Strickland PA, Bandera EV, Hwang KO. Feasibility and potential efficacy of commercial mHealth/eHealth tools for weight loss in African American breast cancer survivors: pilot randomized controlled trial. Transl Behav Med. 2020 Oct 8;10(4):938-948. doi: 10.1093/tbm/iby124.