eHealth Weight Loss Program in African American Breast Cancer Survivors

NCT ID: NCT02699983

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-08
• Study Completion Date: 2018-07-29

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group I (SparkPeople program)

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 Type: EXPERIMENTAL

Behavioral Dietary Intervention

Intervention Type: BEHAVIORAL

Use SparkPeople web-based program

Exercise Intervention

Intervention Type: BEHAVIORAL

Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device

Intervention Type: DEVICE

Wear Fitbit activity monitoring device

Group II (wait list)

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 Type: ACTIVE_COMPARATOR

Activity Monitoring Device

Intervention Type: DEVICE

Wear Fitbit activity monitoring device

Interventions

Behavioral Dietary Intervention

Use SparkPeople web-based program

Intervention Type: BEHAVIORAL

Exercise Intervention

Use Fitbit monitor and SparkPeople web-based program

Intervention Type: BEHAVIORAL

Activity Monitoring Device

Wear Fitbit activity monitoring device

Intervention Type: DEVICE

Other Intervention Names

Monitor

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Jeanne M. Ferrante, MD, MPH

Professor, Deparment of Family Medicine, RWJMS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeanne Ferrante

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30535101 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCI-2015-02137

Identifier Type: REGISTRY

Identifier Source: secondary_id

Pro20150001595

Identifier Type: OTHER

Identifier Source: secondary_id

131404

Identifier Type: OTHER

Identifier Source: secondary_id

R21CA191431

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro20150001595

Identifier Type: -

Identifier Source: org_study_id