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eHealth Weight Loss Program in African American Breast Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 1, 2016
First Posted Date  ICMJE March 7, 2016
Results First Submitted Date  ICMJE March 6, 2019
Results First Posted Date  ICMJE August 6, 2019
Last Update Posted Date August 6, 2019
Actual Study Start Date  ICMJE January 8, 2016
Actual Primary Completion Date July 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
  • Recruitment Rate [ Time Frame: 12 months ]
    Number of eligible participants who were enrolled and randomly assigned. Feasibility is defined as >= 75% recruitment rate.
  • Retention Rate [ Time Frame: 6 months ]
    Number of participants completing study. Feasibility will be defined as >= 80% retention rate.
  • Adherence to SparkPeople- Logged in [ Time Frame: 0-3 months after intervention ]
    average number of days logged per week in to SparkPeople website
  • Adherence to SparkPeople- Logged in [ Time Frame: 4-6 months after intervention ]
    Average number of days per week logged in to SparkPeople website
  • Adherence to SparkPeople- Logged Food [ Time Frame: 0-3 months after intervention ]
    Average number of days per week logged food into SparkPeople
  • Adherence to SparkPeople- Logged Food [ Time Frame: 4-6 months after intervention ]
    Average number of days per week logged food into SparkPeople
  • 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
  • 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
  • Adherence to Fitbit [ Time Frame: 0-3 months after intervention ]
    average days used Fitbit per week
  • Adherence to Fitbit [ Time Frame: 4-6 months after intervention ]
    average days used Fitbit per week
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: March 1, 2016)
  • Changes in weight, measured using the Women's Circle of Health Study protocol and measuring instruments [ Time Frame: Baseline to up to 12 months ]
    The goal will be a decrease of at least 5% decrease within 6 months. Assessed using mixed linear models. Correlations among outcomes will be assessed, potential moderators and mediators of outcomes will be examined, and patterns of missing data will be characterized. The percent variation explained and the significance of potential mediators will be examined by combining effects from component regression models. The product of the two regression coefficients governing the mediating path (from intervention group to mediating variable and mediating variable to outcome) will be multiplied togethe
  • Recruitment Rate [ Time Frame: 12 months ]
    Feasibility will be defined as >= 75% recruitment rate and >= 80% retention rate.
  • Retention Rate [ Time Frame: 12 months ]
    Feasibility will be defined as >= 75% recruitment rate and >= 80% retention rate.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
  • Change in Weight [ Time Frame: baseline and 3 months ]
    Change in weight from baseline
  • Change in Weight [ Time Frame: baseline and 6 months ]
    Change in weight from baseline
  • Change in Waist Circumference [ Time Frame: baseline and 3 months ]
    Change in waist circumference from baseline
  • Change in Waist Circumference [ Time Frame: baseline and 6 months ]
    Change in waist circumference from baseline
  • Change in Caloric Intake [ Time Frame: baseline and 3 months ]
    Changes in caloric intake per day, measured by 24-hour recall
  • Change in Caloric Intake [ Time Frame: baseline and 6 months ]
    Changes in caloric intake per day, measured by 24-hour recall
  • Change in Physical Activity [ Time Frame: baseline and 3 months ]
    change in average number of steps per day measured using Fitbit monitor
  • Change in Physical Activity [ Time Frame: baseline and 6 months ]
    change in average number of steps per day measured using Fitbit monitor
  • Cardiopulmonary Fitness [ Time Frame: baseline and 3 months ]
    change in fitness, measured by the 6-minute walk test
  • Cardiopulmonary Fitness [ Time Frame: baseline and 6 months ]
    change in fitness, measured by the 6-minute walk test
  • 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
  • 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
  • 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)
  • 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)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2016)
  • Changes in caloric intake, measured by 24-hour recall administered by research assistant using Sparkpeople.com tool [ Time Frame: Baseline to up to 12 months ]
    Assessed using mixed linear models. Hierarchical logistic models will be used for binary outcomes. Correlations among outcomes will be assessed, potential moderators and mediators of outcomes will be examined, and patterns of missing data will be characterized. The percent variation explained and the significance of potential mediators will be examined by combining effects from component regression models. The product of the two regression coefficients governing the mediating path (from intervention group to mediating variable and mediating variable to outcome) will be multiplied together and
  • Changes in cardiometabolic risk factors, measured using standard procedures [ Time Frame: Baseline to up to 12 months ]
    Blood pressure will be measured following standardized procedures. Fasting serum lipids, glucose and hemoglobin A1C will be obtained through laboratory testing. Assessed using mixed linear models. Hierarchical logistic models will be used for binary outcomes. Correlations among outcomes will be assessed, potential moderators and mediators of outcomes will be examined, and patterns of missing data will be characterized. The percent variation explained and the significance of potential mediators will be examined by combining effects from component regression models. The product of the two regres
  • Changes in cardiopulmonary fitness, measured by the 6-minute walk test [ Time Frame: Baseline to up to 12 months ]
    Assessed using mixed linear models. Hierarchical logistic models will be used for binary outcomes. Correlations among outcomes will be assessed, potential moderators and mediators of outcomes will be examined, and patterns of missing data will be characterized. The percent variation explained and the significance of potential mediators will be examined by combining effects from component regression models. The product of the two regression coefficients governing the mediating path (from intervention group to mediating variable and mediating variable to outcome) will be multiplied together and
  • Changes in physical activity levels, measured by direct data downloads from the Fitbit server via the Fitabase research platform [ Time Frame: Baseline to up to 12 months ]
    Assessed using mixed linear models. Hierarchical logistic models will be used for binary outcomes. Correlations among outcomes will be assessed, potential moderators and mediators of outcomes will be examined, and patterns of missing data will be characterized. The percent variation explained and the significance of potential mediators will be examined by combining effects from component regression models. The product of the two regression coefficients governing the mediating path (from intervention group to mediating variable and mediating variable to outcome) will be multiplied together and
  • Changes in quality of life, measured using Quality of Life in Adult Cancer Survivors Scale [ Time Frame: Baseline to up to 12 months ]
    Assessed using mixed linear models. Hierarchical logistic models will be used for binary outcomes. Correlations among outcomes will be assessed, potential moderators and mediators of outcomes will be examined, and patterns of missing data will be characterized. The percent variation explained and the significance of potential mediators will be examined by combining effects from component regression models. The product of the two regression coefficients governing the mediating path (from intervention group to mediating variable and mediating variable to outcome) will be multiplied together and
  • Changes in Social Cognitive Theory variables, measured by the Health Beliefs Survey [ Time Frame: Baseline to up to 12 months ]
    Assessed using mixed linear models. Hierarchical logistic models will be used for binary outcomes. Correlations among outcomes will be assessed, potential moderators and mediators of outcomes will be examined, and patterns of missing data will be characterized. The percent variation explained and the significance of potential mediators will be examined by combining effects from component regression models. The product of the two regression coefficients governing the mediating path (from intervention group to mediating variable and mediating variable to outcome) will be multiplied together and
  • Patient feedback on program, as measured by semi-structured interview [ Time Frame: Up to 12 months ]
    Patient satisfaction (e.g., ease of use of website, usefulness of content, extra training and support needed), barriers to participation (e.g., lack of computer access, lack of skills, time, interest, etc.), and any use of internet tools or other strategies outside of intervention will be measured by semi-structured interviews.
  • Use of Fitbit monitor, measured by the percentage of patients who wore the monitor and synced data [ Time Frame: Up to 12 months ]
  • Use of website, measured by SparkPeople-provided data [ Time Frame: Up to 12 months ]
    The number of log-ins, time spent on site, and use of features will be tracked, with objective data provided by SparkPeople.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE eHealth Weight Loss Program in African American Breast Cancer Survivors
Official Title  ICMJE Virtual Weight Loss Program for African-American Breast Cancer Survivors
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.

    Interventions:
    • Behavioral: Behavioral Dietary Intervention
    • Behavioral: Exercise Intervention
    • Device: Activity Monitoring Device
  • 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.
    Intervention: Device: Activity Monitoring Device
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2019)
35
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2016)
70
Actual Study Completion Date  ICMJE July 29, 2018
Actual Primary Completion Date July 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02699983
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeanne M. Ferrante, MD, MPH, Rutgers, The State University of New Jersey
Study Sponsor  ICMJE Rutgers, The State University of New Jersey
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Jeanne Ferrante Rutgers Cancer Institute of New Jersey
PRS Account Rutgers, The State University of New Jersey
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP