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eHealth Weight Loss Program in African American Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT02699983
Recruitment Status : Completed
First Posted : March 7, 2016
Results First Posted : August 6, 2019
Last Update Posted : August 6, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jeanne M. Ferrante, MD, MPH, 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.

Condition or disease Intervention/treatment Phase
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 Behavioral: Behavioral Dietary Intervention Behavioral: Exercise Intervention Device: Activity Monitoring Device Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Virtual Weight Loss Program for African-American Breast Cancer Survivors
Actual Study Start Date : January 8, 2016
Actual Primary Completion Date : July 20, 2018
Actual Study Completion Date : July 29, 2018


Arm Intervention/treatment
Experimental: 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.

Behavioral: Behavioral Dietary Intervention
Use SparkPeople web-based program

Behavioral: Exercise Intervention
Use Fitbit monitor and SparkPeople web-based program

Device: Activity Monitoring Device
Wear Fitbit activity monitoring device
Other Name: Monitor

Active Comparator: 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.
Device: Activity Monitoring Device
Wear Fitbit activity monitoring device
Other Name: Monitor




Primary Outcome Measures :
  1. Recruitment Rate [ Time Frame: 12 months ]
    Number of eligible participants who were enrolled and randomly assigned. Feasibility is defined as >= 75% recruitment rate.

  2. Retention Rate [ Time Frame: 6 months ]
    Number of participants completing study. Feasibility will be defined as >= 80% retention rate.

  3. Adherence to SparkPeople- Logged in [ Time Frame: 0-3 months after intervention ]
    average number of days logged per week in to SparkPeople website

  4. Adherence to SparkPeople- Logged in [ Time Frame: 4-6 months after intervention ]
    Average number of days per week logged in to SparkPeople website

  5. Adherence to SparkPeople- Logged Food [ Time Frame: 0-3 months after intervention ]
    Average number of days per week logged food into SparkPeople

  6. Adherence to SparkPeople- Logged Food [ Time Frame: 4-6 months after intervention ]
    Average number of days per week logged food into SparkPeople

  7. Acceptability of SparkPeople [ Time Frame: 0-3 months after intervention ]
    Usefulness of SparkPeople website on 1 (not useful at all) to 4 (very useful) scale

  8. Acceptability of SparkPeople [ Time Frame: 4-6 months after intervention ]
    Usefulness of SparkPeople website on 1 (not useful at all) to 4 (very useful) scale

  9. Adherence to Fitbit [ Time Frame: 0-3 months after intervention ]
    average days used Fitbit per week

  10. Adherence to Fitbit [ Time Frame: 4-6 months after intervention ]
    average days used Fitbit per week

  11. Acceptability of Fitbit [ Time Frame: 0-3 months after intervention ]
    Usefulness of Fitbit, rated on 1 (not useful at all) to 4 (very useful) scale

  12. Acceptability of Fitbit [ Time Frame: 4-6 months after intervention ]
    Usefulness of Fitbit, rated on 1 (not useful at all) to 4 (very useful) scale


Secondary Outcome Measures :
  1. Change in Weight [ Time Frame: baseline and 3 months ]
    Change in weight from baseline

  2. Change in Weight [ Time Frame: baseline and 6 months ]
    Change in weight from baseline

  3. Change in Waist Circumference [ Time Frame: baseline and 3 months ]
    Change in waist circumference from baseline

  4. Change in Waist Circumference [ Time Frame: baseline and 6 months ]
    Change in waist circumference from baseline

  5. Change in Caloric Intake [ Time Frame: baseline and 3 months ]
    Changes in caloric intake per day, measured by 24-hour recall

  6. Change in Caloric Intake [ Time Frame: baseline and 6 months ]
    Changes in caloric intake per day, measured by 24-hour recall

  7. Change in Physical Activity [ Time Frame: baseline and 3 months ]
    change in average number of steps per day measured using Fitbit monitor

  8. Change in Physical Activity [ Time Frame: baseline and 6 months ]
    change in average number of steps per day measured using Fitbit monitor

  9. Cardiopulmonary Fitness [ Time Frame: baseline and 3 months ]
    change in fitness, measured by the 6-minute walk test

  10. Cardiopulmonary Fitness [ Time Frame: baseline and 6 months ]
    change in fitness, measured by the 6-minute walk test

  11. Change in Quality of Life [ Time Frame: baseline and 3 months ]
    measured using Quality of Life in Adult Cancer Survivors Scale (minimum 65, maximum 257); higher scores mean worse quality of life

  12. Change in Quality of Life [ Time Frame: 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

  13. Self-efficacy, Eating Healthy Foods [ Time Frame: baseline and 3 months ]
    change in self-efficacy, eating healthy foods, measured with Health Beliefs Survey, scale range 0 (certain I cannot) to 100 (certain I can)

  14. Self-efficacy, Eating Healthy Foods [ Time Frame: 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)

  15. Social Support for Healthy Nutrition [ Time Frame: baseline and 3 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

  16. Social Support for Healthy Nutrition [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699983


Locations
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United States, New Jersey
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jeanne Ferrante Rutgers Cancer Institute of New Jersey
  Study Documents (Full-Text)

Documents provided by Jeanne M. Ferrante, MD, MPH, Rutgers, The State University of New Jersey:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jeanne M. Ferrante, MD, MPH, Professor, Deparment of Family Medicine, RWJMS, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT02699983     History of Changes
Other Study ID Numbers: 131404
NCI-2015-02137 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Pro20150001595 ( Other Identifier: Rutgers University eIRB )
131404 ( Other Identifier: Rutgers Cancer Institute of New Jersey )
R21CA191431 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2016    Key Record Dates
Results First Posted: August 6, 2019
Last Update Posted: August 6, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Breast Carcinoma In Situ
Weight Loss
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type