eHealth Weight Loss Program in African American Breast Cancer Survivors

NCT02699983 | Completed Results

• 4 other identifiers: Pro20150001595NCI-2015-02137131404R21CA191431
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (12)

• Recruitment Rate

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

  12 months

• Retention Rate

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

  6 months

• Adherence to SparkPeople- Logged in

  average number of days logged per week in to SparkPeople website

  0-3 months after intervention

• Adherence to SparkPeople- Logged in

  Average number of days per week logged in to SparkPeople website

  4-6 months after intervention

• Adherence to SparkPeople- Logged Food

  Average number of days per week logged food into SparkPeople

  0-3 months after intervention

• Adherence to SparkPeople- Logged Food

  Average number of days per week logged food into SparkPeople

  4-6 months after intervention

• Acceptability of SparkPeople

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

  0-3 months after intervention

• Acceptability of SparkPeople

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

  4-6 months after intervention

• Adherence to Fitbit

  average days used Fitbit per week

  0-3 months after intervention

• Adherence to Fitbit

  average days used Fitbit per week

  4-6 months after intervention

• Acceptability of Fitbit

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

  0-3 months after intervention

• Acceptability of Fitbit

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

  4-6 months after intervention

Secondary Outcomes (16)

• Change in Weight

  baseline and 3 months

• Change in Weight

  baseline and 6 months

• Change in Waist Circumference

  baseline and 3 months

• Change in Waist Circumference

  baseline and 6 months

• Change in Caloric Intake

  baseline and 3 months

Study Arms (2)

Group I (SparkPeople program)

EXPERIMENTAL

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.

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

Group II (wait list)

ACTIVE COMPARATOR

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.

Device: Activity Monitoring Device

Interventions

Behavioral Dietary Intervention BEHAVIORAL

Use SparkPeople web-based program

Group I (SparkPeople program)

Exercise Intervention BEHAVIORAL

Use Fitbit monitor and SparkPeople web-based program

Group I (SparkPeople program)

Activity Monitoring Device DEVICE

Wear Fitbit activity monitoring device

Also known as: Monitor

Group I (SparkPeople program); Group II (wait list)

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (1)

• 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.

  PMID: 30535101 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Breast Carcinoma In Situ

Interventions

Monitoring, Physiologic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Jeanne Ferrante
• Organization: Rutgers Robert Wood Johnson Medical School

jeanne.ferrante@rutgers.edu

848-932-5252

Study Officials

• Jeanne Ferrante

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Deparment of Family Medicine, RWJMS

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 7, 2016
• Study Start: January 8, 2016
• Primary Completion: July 20, 2018
• Study Completion: July 29, 2018
• Last Updated: April 13, 2021
• Results First Posted: August 6, 2019

Record last verified: 2021-04

Locations

US (1)