12 Months Weight Loss Study Using Feedback Messages Delivered Via Smartphone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 502
- 试验地点
- 1
- 主要终点
- Change in weight
研究概览
简要总结
The overall purpose of this randomized clinical trial is to examine the effect and efficacy of the individualized, real-time, smartphone-based feedback of diet and physical activity self-monitoring on subsequent weight-control behaviors, weight loss outcomes and sustainability of patient engagement. Participants will be randomized to one of 2 groups: (1) Self-Monitoring -similar to what many people do on their own, subjects will self-monitor diet, physical activity using Fitbit and weight using a Bluetooth-enabled scale, and (2) Self-Monitoring +Feedback-participants will self-monitor as described for the Self-Monitoring group but also will receive tailored Feedback messages. The Self-Monitoring +Feedback participants will receive up to 4 daily discrete pop-up Feedback messages on the participant's smartphone delivered at random times during waking hours and tailored to content of recorded entries in the subjects' smartphone-based diaries and a weekly summary Feedback message about the participant's weight.
详细描述
This study includes the following activities:
- Screening:
Phase I: It will be conducted online. Respondents to recruitment solicitations will be provided an online Uniform Resource Locator (URL) with a hyperlink to a study flier that describes the essential elements of the study. It will also include a choice of URL or Quick Response (QR) code to access an online survey that will provide more details about the study. The research staff will also ask preliminary questions about eligibility (age, height and weight to calculate BMI), and consent to have the research team review the participant's answers.
Phase II: It will be conducted online. After completing an online consent, the participants will provide personal information in the Sociodemographic and Lifestyle Questionnaire and health and medical conditions in the General Health History questionnaire as well as the Center for Epidemiologic Studies Depression Scale (CES-D) and the Eating Habits Checklist to screen for eating disorders.
Run-in period: To minimize attrition and ensure that potential subjects are appropriate for the intervention, research staff will teach all eligible individuals how to download and complete a 5-day Self-Monitoring diary using the My Food Diary (Fitbit) Self-Monitoring program on the participant's phone or computer. After review of the diary, research staff will contact the potential participant to schedule the baseline assessment. Individuals need to record at least 700 kcal/day of food intake to be eligible for the study. Each user will have a username and password and also have the ability to manage the participant's own privacy settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Currently own and regularly use a smartphone
- •Age ≥18 years;
- •BMI > 27 and < 43; and
- •Successful completion of a 5-day electronic diary of food intake during a run-in period.
排除标准
- •Presence of an unstable condition requiring physician-supervised diet and exercise (e.g., recent myocardial infarction);
- •Physical limitations precluding ability to engage in moderate-intensity physical activity;
- •Pregnancy or intention to become pregnant during study;
- •Current treatment for a serious mental illness (e.g. schizophrenia);
- •Reported alcohol intake > 4 drinks/day;
- •Participation in a formal weight loss program, loss of ≥ 5% weight in past 6 month, or current use of weight loss medication;
- •History of bariatric surgery in <5 years,
- •Planned extended vacations, absences, or relocation during study;
- •A score >16 on the Center for Epidemiologic Studies Depression Scale (CES-D);
- •Score >32 on the Eating Habits Checklist, an eating disorder scale administered at baseline. For those who have an elevated BDI score (>22) or EHC (>32), we offer referral for counseling.
研究组 & 干预措施
Self-monitoring group
All subjects will use a smartphone to self-monitor diet and monitor physical activity (Fitbit Charge 2), and a Withings or Fitibit digital scale for weight. Following randomization, participants will be oriented to Self-monitoring and provided a tutorial with images shown on the laptop and devices as well as printed materials showing the screen shots. At baseline, each participant will have a one-on-one session with the project interventionist, which covers the core principles of behavioral weight loss. The participant also will be given personalized fat, calorie, and PA goals for weight loss and information about how to access the intervention materials from the Diabetes Prevention Program (DPP) online which is publicly available (https://www.diabetesprevention.pitt.edu/).
干预措施: One-on-one Session (Behavioral)
Self-monitoring group
All subjects will use a smartphone to self-monitor diet and monitor physical activity (Fitbit Charge 2), and a Withings or Fitibit digital scale for weight. Following randomization, participants will be oriented to Self-monitoring and provided a tutorial with images shown on the laptop and devices as well as printed materials showing the screen shots. At baseline, each participant will have a one-on-one session with the project interventionist, which covers the core principles of behavioral weight loss. The participant also will be given personalized fat, calorie, and PA goals for weight loss and information about how to access the intervention materials from the Diabetes Prevention Program (DPP) online which is publicly available (https://www.diabetesprevention.pitt.edu/).
干预措施: Self-monitoring (Behavioral)
Self-monitoring+Feedback group
All subjects will be asked to do everything the self-monitoring group is asked to do. Subjects will receive up to 4 Feedback messages per day (messages will be delivered between the hours set by the participants on the participant's phone, e.g., 8 AM and 9:30 PM). Messages will be delivered automatically, remotely and in real-time. Messages will be tailored to each participant's progress based on standardized algorithms. The Feedback program will be explained to them and how this is responsive to information entered on the self-monitoring diaries.
干预措施: One-on-one Session (Behavioral)
Self-monitoring+Feedback group
All subjects will be asked to do everything the self-monitoring group is asked to do. Subjects will receive up to 4 Feedback messages per day (messages will be delivered between the hours set by the participants on the participant's phone, e.g., 8 AM and 9:30 PM). Messages will be delivered automatically, remotely and in real-time. Messages will be tailored to each participant's progress based on standardized algorithms. The Feedback program will be explained to them and how this is responsive to information entered on the self-monitoring diaries.
干预措施: Self-monitoring (Behavioral)
Self-monitoring+Feedback group
All subjects will be asked to do everything the self-monitoring group is asked to do. Subjects will receive up to 4 Feedback messages per day (messages will be delivered between the hours set by the participants on the participant's phone, e.g., 8 AM and 9:30 PM). Messages will be delivered automatically, remotely and in real-time. Messages will be tailored to each participant's progress based on standardized algorithms. The Feedback program will be explained to them and how this is responsive to information entered on the self-monitoring diaries.
干预措施: Feedback (Behavioral)
结局指标
主要结局
Change in weight
时间窗: 6 and 12 months
Changes in weight: measured as percent change in weight from baseline to 6 and 12 months
次要结局
- Adherence to behavioral goals(6 and 12 months)
- Adherence to self-weighing(6 and 12 months)
- Adherence to treatment protocol(6 and 12 months)
研究者
Lora Burke
Professor of Nursing and Epidemiology
University of Pittsburgh