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OpenTrials
Completed

NCT Number: NCT02699983

eHealth Weight Loss Program in African American Breast Cancer Survivors

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

behavioral dietary intervention

Behavioral

Use SparkPeople web-based program

Exercise Intervention

Behavioral

Use Fitbit monitor and SparkPeople web-based program

Activity Monitoring Device

Device

Wear Fitbit activity monitoring device

Other names: Monitor

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Virtual Weight Loss Program for African-American Breast Cancer Survivors

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 7, 2016
Registry last updated
Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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