Virtual Weight Loss Program for African-American Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Adherence to SparkPeople- Logged in
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Behavioral Dietary Intervention (Behavioral)
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.
干预措施: Exercise Intervention (Behavioral)
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.
干预措施: Activity Monitoring Device (Device)
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.
干预措施: Activity Monitoring Device (Device)
结局指标
主要结局
Adherence to SparkPeople- Logged in
时间窗: 4-6 months after intervention
Average number of days per week logged in to SparkPeople website
Acceptability of SparkPeople
时间窗: 4-6 months after intervention
Usefulness of SparkPeople website on 1 (not useful at all) to 4 (very useful) scale
Recruitment Rate
时间窗: 12 months
Number of eligible participants who were enrolled and randomly assigned. Feasibility is defined as \>= 75% recruitment rate.
Adherence to Fitbit
时间窗: 4-6 months after intervention
average days used Fitbit per week
Adherence to SparkPeople- Logged Food
时间窗: 4-6 months after intervention
Average number of days per week logged food into SparkPeople
Retention Rate
时间窗: 6 months
Number of participants completing study. Feasibility will be defined as \>= 80% retention rate.
Acceptability of Fitbit
时间窗: 4-6 months after intervention
Usefulness of Fitbit, rated on 1 (not useful at all) to 4 (very useful) scale
Adherence to SparkPeople- Logged in
时间窗: 0-3 months after intervention
average number of days logged per week in to SparkPeople website
Adherence to SparkPeople- Logged Food
时间窗: 0-3 months after intervention
Average number of days per week logged food into SparkPeople
Acceptability of SparkPeople
时间窗: 0-3 months after intervention
Usefulness of SparkPeople website on 1 (not useful at all) to 4 (very useful) scale
Adherence to Fitbit
时间窗: 0-3 months after intervention
average days used Fitbit per week
Acceptability of Fitbit
时间窗: 0-3 months after intervention
Usefulness of Fitbit, rated on 1 (not useful at all) to 4 (very useful) scale
次要结局
- Change in Weight(baseline and 6 months)
- Change in Waist Circumference(baseline and 6 months)
- Change in Quality of Life(baseline and 6 months)
- Change in Caloric Intake(baseline and 6 months)
- Change in Physical Activity(baseline and 6 months)
- Cardiopulmonary Fitness(baseline and 6 months)
- Self-efficacy, Eating Healthy Foods(baseline and 6 months)
- Social Support for Healthy Nutrition(baseline and 6 months)
- Change in Weight(baseline and 3 months)
- Change in Waist Circumference(baseline and 3 months)
- Change in Caloric Intake(baseline and 3 months)
- Change in Physical Activity(baseline and 3 months)
- Cardiopulmonary Fitness(baseline and 3 months)
- Change in Quality of Life(baseline and 3 months)
- Self-efficacy, Eating Healthy Foods(baseline and 3 months)
- Social Support for Healthy Nutrition(baseline and 3 months)
研究者
Jeanne M. Ferrante, MD, MPH
Professor, Deparment of Family Medicine, RWJMS
Rutgers, The State University of New Jersey