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Trial record 26 of 35 for:    breast cancer weight gain

Virtual Weight Loss Program in Maintaining Weight in African American Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT02699983
Recruitment Status : Active, not recruiting
First Posted : March 7, 2016
Last Update Posted : January 29, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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 Invasive Breast Carcinoma 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 Behavioral: Behavioral Dietary Intervention Behavioral: Exercise Intervention Device: Monitoring Device Procedure: Psychosocial Assessment and Care Other: Quality-of-Life Assessment Other: Questionnaire Administration 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, 9, 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.

After completion of study treatment, patients from Group I are followed up for 6 months.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 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 : May 20, 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019


Arm Intervention/treatment
Experimental: Group I (SparkPeople program)
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.
Behavioral: Behavioral Dietary Intervention
Undergo SparkPeople program

Behavioral: Exercise Intervention
Undergo SparkPeople program

Device: Monitoring Device
Wear health monitoring device
Other Name: Monitor

Procedure: Psychosocial Assessment and Care
Undergo SparkPeople program
Other Names:
  • Psychosocial Assessment
  • Psychosocial Care
  • Psychosocial Care/Assessment
  • Psychosocial Studies
  • Psychosocial Support

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Correlative studies

Active Comparator: Group II (wait list)
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.
Device: Monitoring Device
Wear health monitoring device
Other Name: Monitor

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Correlative studies




Primary Outcome Measures :
  1. 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

  2. Recruitment rate [ Time Frame: 12 months ]
    Feasibility will be defined as >= 75% recruitment rate and >= 80% retention rate.

  3. Retention rate [ Time Frame: 12 months ]
    Feasibility will be defined as >= 75% recruitment rate and >= 80% retention rate.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. Use of Fitbit monitor, measured by the percentage of patients who wore the monitor and synced data [ Time Frame: Up to 12 months ]
  9. 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.



Information from the National Library of Medicine

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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 invasive breast cancer, stage I, II or III, and be at least 2 years post diagnosis
  • Patient is self-identified as African-American
  • Patient is obese (body mass index [BMI] >= 30 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 Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: 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) )
20150001595
Pro20150001595
131404 ( Other Identifier: Rutgers Cancer Institute of New Jersey )
P30CA072720 ( U.S. NIH Grant/Contract )
R21CA191431 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: June 2018

Additional relevant MeSH terms:
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Breast Neoplasms
Weight Loss
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Body Weight Changes
Body Weight
Signs and Symptoms