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eHealth Weight Loss Program in African American Breast Cancer Survivors

Primary Purpose

Cancer Survivor, Stage IA Breast Cancer, Stage IB Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Dietary Intervention
Exercise Intervention
Activity Monitoring Device
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer Survivor

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Rutgers Robert Wood Johnson Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I (SparkPeople program)

Group II (wait list)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Recruitment Rate
Number of eligible participants who were enrolled and randomly assigned. Feasibility is defined as >= 75% recruitment rate.
Retention Rate
Number of participants completing study. Feasibility will be defined as >= 80% retention rate.
Adherence to SparkPeople- Logged in
average number of days logged per week in to SparkPeople website
Adherence to SparkPeople- Logged in
Average number of days per week logged in to SparkPeople website
Adherence to SparkPeople- Logged Food
Average number of days per week logged food into SparkPeople
Adherence to SparkPeople- Logged Food
Average number of days per week logged food into SparkPeople
Acceptability of SparkPeople
Usefulness of SparkPeople website on 1 (not useful at all) to 4 (very useful) scale
Acceptability of SparkPeople
Usefulness of SparkPeople website on 1 (not useful at all) to 4 (very useful) scale
Adherence to Fitbit
average days used Fitbit per week
Adherence to Fitbit
average days used Fitbit per week
Acceptability of Fitbit
Usefulness of Fitbit, rated on 1 (not useful at all) to 4 (very useful) scale
Acceptability of Fitbit
Usefulness of Fitbit, rated on 1 (not useful at all) to 4 (very useful) scale

Secondary Outcome Measures

Change in Weight
Change in weight from baseline
Change in Weight
Change in weight from baseline
Change in Waist Circumference
Change in waist circumference from baseline
Change in Waist Circumference
Change in waist circumference from baseline
Change in Caloric Intake
Changes in caloric intake per day, measured by 24-hour recall
Change in Caloric Intake
Changes in caloric intake per day, measured by 24-hour recall
Change in Physical Activity
change in average number of steps per day measured using Fitbit monitor
Change in Physical Activity
change in average number of steps per day measured using Fitbit monitor
Cardiopulmonary Fitness
change in fitness, measured by the 6-minute walk test
Cardiopulmonary Fitness
change in fitness, measured by the 6-minute walk test
Change in Quality of Life
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
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
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
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
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
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

Full Information

First Posted
March 1, 2016
Last Updated
April 9, 2021
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02699983
Brief Title
eHealth Weight Loss Program in African American Breast Cancer Survivors
Official Title
Virtual Weight Loss Program for African-American Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 8, 2016 (Actual)
Primary Completion Date
July 20, 2018 (Actual)
Study Completion Date
July 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (SparkPeople program)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group II (wait list)
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Behavioral Dietary Intervention
Intervention Description
Use SparkPeople web-based program
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Use Fitbit monitor and SparkPeople web-based program
Intervention Type
Device
Intervention Name(s)
Activity Monitoring Device
Other Intervention Name(s)
Monitor
Intervention Description
Wear Fitbit activity monitoring device
Primary Outcome Measure Information:
Title
Recruitment Rate
Description
Number of eligible participants who were enrolled and randomly assigned. Feasibility is defined as >= 75% recruitment rate.
Time Frame
12 months
Title
Retention Rate
Description
Number of participants completing study. Feasibility will be defined as >= 80% retention rate.
Time Frame
6 months
Title
Adherence to SparkPeople- Logged in
Description
average number of days logged per week in to SparkPeople website
Time Frame
0-3 months after intervention
Title
Adherence to SparkPeople- Logged in
Description
Average number of days per week logged in to SparkPeople website
Time Frame
4-6 months after intervention
Title
Adherence to SparkPeople- Logged Food
Description
Average number of days per week logged food into SparkPeople
Time Frame
0-3 months after intervention
Title
Adherence to SparkPeople- Logged Food
Description
Average number of days per week logged food into SparkPeople
Time Frame
4-6 months after intervention
Title
Acceptability of SparkPeople
Description
Usefulness of SparkPeople website on 1 (not useful at all) to 4 (very useful) scale
Time Frame
0-3 months after intervention
Title
Acceptability of SparkPeople
Description
Usefulness of SparkPeople website on 1 (not useful at all) to 4 (very useful) scale
Time Frame
4-6 months after intervention
Title
Adherence to Fitbit
Description
average days used Fitbit per week
Time Frame
0-3 months after intervention
Title
Adherence to Fitbit
Description
average days used Fitbit per week
Time Frame
4-6 months after intervention
Title
Acceptability of Fitbit
Description
Usefulness of Fitbit, rated on 1 (not useful at all) to 4 (very useful) scale
Time Frame
0-3 months after intervention
Title
Acceptability of Fitbit
Description
Usefulness of Fitbit, rated on 1 (not useful at all) to 4 (very useful) scale
Time Frame
4-6 months after intervention
Secondary Outcome Measure Information:
Title
Change in Weight
Description
Change in weight from baseline
Time Frame
baseline and 3 months
Title
Change in Weight
Description
Change in weight from baseline
Time Frame
baseline and 6 months
Title
Change in Waist Circumference
Description
Change in waist circumference from baseline
Time Frame
baseline and 3 months
Title
Change in Waist Circumference
Description
Change in waist circumference from baseline
Time Frame
baseline and 6 months
Title
Change in Caloric Intake
Description
Changes in caloric intake per day, measured by 24-hour recall
Time Frame
baseline and 3 months
Title
Change in Caloric Intake
Description
Changes in caloric intake per day, measured by 24-hour recall
Time Frame
baseline and 6 months
Title
Change in Physical Activity
Description
change in average number of steps per day measured using Fitbit monitor
Time Frame
baseline and 3 months
Title
Change in Physical Activity
Description
change in average number of steps per day measured using Fitbit monitor
Time Frame
baseline and 6 months
Title
Cardiopulmonary Fitness
Description
change in fitness, measured by the 6-minute walk test
Time Frame
baseline and 3 months
Title
Cardiopulmonary Fitness
Description
change in fitness, measured by the 6-minute walk test
Time Frame
baseline and 6 months
Title
Change in Quality of Life
Description
measured using Quality of Life in Adult Cancer Survivors Scale (minimum 65, maximum 257); higher scores mean worse quality of life
Time Frame
baseline and 3 months
Title
Change in Quality of Life
Description
measured using Quality of Life in Adult Cancer Survivors Scale (minimum 65, maximum 257); higher scores mean worse quality of life
Time Frame
baseline and 6 months
Title
Self-efficacy, Eating Healthy Foods
Description
change in self-efficacy, eating healthy foods, measured with Health Beliefs Survey, scale range 0 (certain I cannot) to 100 (certain I can)
Time Frame
baseline and 3 months
Title
Self-efficacy, Eating Healthy Foods
Description
change in self-efficacy, eating healthy foods, measured with Health Beliefs Survey, scale range 0 (certain I cannot) to 100 (certain I can)
Time Frame
baseline and 6 months
Title
Social Support for Healthy Nutrition
Description
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
Time Frame
baseline and 3 months
Title
Social Support for Healthy Nutrition
Description
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
Time Frame
baseline and 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanne Ferrante
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30535101
Citation
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.
Results Reference
derived

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eHealth Weight Loss Program in African American Breast Cancer Survivors

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