Optimization and Evaluation of a Tailored Behavioral eHealth/mHealth Weight Loss Intervention for Cardiac Rehabilitation Patients Using the Multiphase Optimization Strategy
试验速览
- 阶段
- 不适用
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Weight Change
研究概览
简要总结
Cardiovascular disease (CVD) is the leading cause of death in the United States. Cardiac rehabilitation (CR) is the main treatment for heart attacks and other types of CVD. It is based on science, it saves money, and it is widely-available. Each session (of which there are a few each week for 3 months) combines supervised exercise and instruction. The goals are to improve overall health and reduce cardiovascular risk in individuals with established CVD. CR produces almost no weight loss (WL); if a person has excess weight while in CR (the majority of participants have overweight or obesity), losing weight could really reduce their risk of having another heart attack. The best treatment available for weight loss, in-person behavioral weight loss interventions (BWLs), produce enough WL that they improve health and disease risk/severity. However, in-person BWLs are too much work to be carried out in CR. A previous fully automated 3-month online program, Rx Weight Loss (RxWL), produced good WL in many different settings. Dr. Goldstein aims to tailor RxWL for use in CR. The study will use the Multiphase Optimization Strategy (MOST) to test innovative eHealth/mHealth intervention components that might work well for people when combined with RxWL. The study will include 160 patients (each randomized to receive 0-4 of the components). The components are: (a) a Fitbit with a goal-setting program; (b) a bite counting device; (c) a Web-based virtual reality (VR) intervention ; and (d) virtual meetings. By the 6-month follow-up, the investigators will know if any of those 4 components helped people lose more weight. If a component produced at least 2% WL, it will be studied further by being included in a new intervention to be tested in the next study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •currently a participant in The Miriam Hospital's or Newport Hospital's outpatient phase II cardiac rehabilitation program
- •medical clearance to participate by the Medical Director
- •a body mass index (BMI) between 27-45 kg/m2
- •must have a personal computer in their home with internet access
- •must read and understand English
- •willing to use technology to assist with weight loss
排除标准
- •currently in another weight loss program
- •taking weight loss medication
- •weight loss of ≥ 5% of body weight in the past 6 months
- •currently pregnant, lactating, < 6 months post-partum, or plans to become pregnant during the next year
- •report of loss of consciousness on the Physical Activity Readiness Questionnaire
- •New York Heart Association Class IV heart failure
- •heart transplant in the last 3 months
- •receipt of left ventricular assist device in the last 2 months
- •a physician diagnosis of dementia
- •a physician prescription for 24 hours of oxygen therapy daily
- •coronary artery bypass surgery in the last 4 weeks
- •current participation in dialysis
- •inability to walk 1 block without stopping
- •report of conditions that in the opinion of the investigators would render them potentially unlikely to follow the protocol including terminal illness, substance abuse, eating disorder, or other significant psychiatric problems
研究组 & 干预措施
Physical Activity
Participants will receive the core 6-month weight loss program and the tailored intervention to promote structured physical activity.
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Physical Activity
Participants will receive the core 6-month weight loss program and the tailored intervention to promote structured physical activity.
干预措施: Physical Activity Intervention (Behavioral)
Core Program
Participants will receive the core 6-month weight loss program alone. This program includes weekly lessons for the first 12 weeks and monthly lessons for the remaining 12 weeks. Participants will track their intake, physical activity, and weight, input these data into the system, and received tailored feedback.
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Physical Activity & Virtual Meetings
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, and the virtual meetings to support weight loss.
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Physical Activity & Virtual Meetings
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, and the virtual meetings to support weight loss.
干预措施: Physical Activity Intervention (Behavioral)
Physical Activity & Virtual Meetings
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, and the virtual meetings to support weight loss.
干预措施: Virtual Meetings (Behavioral)
Virtual Meetings
Participants will receive the core 6-month weight loss program and the virtual meetings to support weight loss.
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Virtual Meetings
Participants will receive the core 6-month weight loss program and the virtual meetings to support weight loss.
干预措施: Virtual Meetings (Behavioral)
Physical Activity & Virtual Reality
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, and access to the virtual reality platform for behavioral weight loss skills training.
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Physical Activity & Virtual Reality
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, and access to the virtual reality platform for behavioral weight loss skills training.
干预措施: Physical Activity Intervention (Behavioral)
Physical Activity & Virtual Reality
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, and access to the virtual reality platform for behavioral weight loss skills training.
干预措施: Virtual Reality (Behavioral)
Virtual Reality
Participants will receive the core 6-month weight loss program and access to the virtual reality platform for behavioral weight loss skills training.
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Virtual Reality
Participants will receive the core 6-month weight loss program and access to the virtual reality platform for behavioral weight loss skills training.
干预措施: Virtual Reality (Behavioral)
Physical Activity, Virtual Reality, & Virtual Meetings
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, the virtual meetings to support weight loss, and access to the virtual reality platform for behavioral weight loss skills training.
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Physical Activity, Virtual Reality, & Virtual Meetings
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, the virtual meetings to support weight loss, and access to the virtual reality platform for behavioral weight loss skills training.
干预措施: Physical Activity Intervention (Behavioral)
Physical Activity, Virtual Reality, & Virtual Meetings
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, the virtual meetings to support weight loss, and access to the virtual reality platform for behavioral weight loss skills training.
干预措施: Virtual Reality (Behavioral)
Physical Activity, Virtual Reality, & Virtual Meetings
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, the virtual meetings to support weight loss, and access to the virtual reality platform for behavioral weight loss skills training.
干预措施: Virtual Meetings (Behavioral)
Virtual Reality & Virtual Meetings
Participants will receive the core 6-month weight loss program, access to the virtual reality platform for behavioral weight loss skills training, and the virtual meetings to support weight loss.
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Virtual Reality & Virtual Meetings
Participants will receive the core 6-month weight loss program, access to the virtual reality platform for behavioral weight loss skills training, and the virtual meetings to support weight loss.
干预措施: Virtual Reality (Behavioral)
Virtual Reality & Virtual Meetings
Participants will receive the core 6-month weight loss program, access to the virtual reality platform for behavioral weight loss skills training, and the virtual meetings to support weight loss.
干预措施: Virtual Meetings (Behavioral)
Physical Activity & Bite Counter
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, and the Bite Counter device to reduce dietary intake.
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Physical Activity & Bite Counter
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, and the Bite Counter device to reduce dietary intake.
干预措施: Physical Activity Intervention (Behavioral)
Physical Activity & Bite Counter
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, and the Bite Counter device to reduce dietary intake.
干预措施: Bite Counter (Behavioral)
Bite Counter
Participants will receive the core 6-month weight loss program and the Bite Counter device to reduce dietary intake.
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Bite Counter
Participants will receive the core 6-month weight loss program and the Bite Counter device to reduce dietary intake.
干预措施: Bite Counter (Behavioral)
Physical Activity, Bite Counter, & Virtual Meetings
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, the Bite Counter device to reduce dietary intake, and the virtual meetings to support weight loss.
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Physical Activity, Bite Counter, & Virtual Meetings
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, the Bite Counter device to reduce dietary intake, and the virtual meetings to support weight loss.
干预措施: Physical Activity Intervention (Behavioral)
Physical Activity, Bite Counter, & Virtual Meetings
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, the Bite Counter device to reduce dietary intake, and the virtual meetings to support weight loss.
干预措施: Bite Counter (Behavioral)
Physical Activity, Bite Counter, & Virtual Meetings
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, the Bite Counter device to reduce dietary intake, and the virtual meetings to support weight loss.
干预措施: Virtual Meetings (Behavioral)
Bite Counter & Virtual Meetings
Participants will receive the core 6-month weight loss program, the Bite Counter device to reduce dietary intake, and the virtual meetings to support weight loss.
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Bite Counter & Virtual Meetings
Participants will receive the core 6-month weight loss program, the Bite Counter device to reduce dietary intake, and the virtual meetings to support weight loss.
干预措施: Bite Counter (Behavioral)
Bite Counter & Virtual Meetings
Participants will receive the core 6-month weight loss program, the Bite Counter device to reduce dietary intake, and the virtual meetings to support weight loss.
干预措施: Virtual Meetings (Behavioral)
Physical Activity, Bite Counter, & Virtual Reality
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, the Bite Counter device to reduce dietary intake, and access to the virtual reality platform for behavioral weight loss skills training.
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Physical Activity, Bite Counter, & Virtual Reality
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, the Bite Counter device to reduce dietary intake, and access to the virtual reality platform for behavioral weight loss skills training.
干预措施: Physical Activity Intervention (Behavioral)
Physical Activity, Bite Counter, & Virtual Reality
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, the Bite Counter device to reduce dietary intake, and access to the virtual reality platform for behavioral weight loss skills training.
干预措施: Bite Counter (Behavioral)
Physical Activity, Bite Counter, & Virtual Reality
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, the Bite Counter device to reduce dietary intake, and access to the virtual reality platform for behavioral weight loss skills training.
干预措施: Virtual Reality (Behavioral)
Bite Counter & Virtual Reality
Participants will receive the core 6-month weight loss program, the Bite Counter device to reduce dietary intake, and access to the virtual reality platform for behavioral weight loss skills training.
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Bite Counter & Virtual Reality
Participants will receive the core 6-month weight loss program, the Bite Counter device to reduce dietary intake, and access to the virtual reality platform for behavioral weight loss skills training.
干预措施: Bite Counter (Behavioral)
Bite Counter & Virtual Reality
Participants will receive the core 6-month weight loss program, the Bite Counter device to reduce dietary intake, and access to the virtual reality platform for behavioral weight loss skills training.
干预措施: Virtual Reality (Behavioral)
Physical Activity, Bite Counter, Virtual Reality & Meetings
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, the Bite Counter device to reduce dietary intake, access to the virtual reality platform for behavioral weight loss skills training, and the virtual meetings to support weight loss.
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Physical Activity, Bite Counter, Virtual Reality & Meetings
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, the Bite Counter device to reduce dietary intake, access to the virtual reality platform for behavioral weight loss skills training, and the virtual meetings to support weight loss.
干预措施: Physical Activity Intervention (Behavioral)
Physical Activity, Bite Counter, Virtual Reality & Meetings
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, the Bite Counter device to reduce dietary intake, access to the virtual reality platform for behavioral weight loss skills training, and the virtual meetings to support weight loss.
干预措施: Bite Counter (Behavioral)
Physical Activity, Bite Counter, Virtual Reality & Meetings
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, the Bite Counter device to reduce dietary intake, access to the virtual reality platform for behavioral weight loss skills training, and the virtual meetings to support weight loss.
干预措施: Virtual Reality (Behavioral)
Physical Activity, Bite Counter, Virtual Reality & Meetings
Participants will receive the core 6-month weight loss program, the tailored intervention to promote structured physical activity, the Bite Counter device to reduce dietary intake, access to the virtual reality platform for behavioral weight loss skills training, and the virtual meetings to support weight loss.
干预措施: Virtual Meetings (Behavioral)
Bite Counter, Virtual Reality, & Virtual Meetings
Participants will receive the core 6-month weight loss program, the Bite Counter device to reduce dietary intake, access to the virtual reality platform for behavioral weight loss skills training, and the virtual meetings to support weight loss.
干预措施: Online Behavioral Weight Loss Program (Behavioral)
Bite Counter, Virtual Reality, & Virtual Meetings
Participants will receive the core 6-month weight loss program, the Bite Counter device to reduce dietary intake, access to the virtual reality platform for behavioral weight loss skills training, and the virtual meetings to support weight loss.
干预措施: Bite Counter (Behavioral)
Bite Counter, Virtual Reality, & Virtual Meetings
Participants will receive the core 6-month weight loss program, the Bite Counter device to reduce dietary intake, access to the virtual reality platform for behavioral weight loss skills training, and the virtual meetings to support weight loss.
干预措施: Virtual Reality (Behavioral)
Bite Counter, Virtual Reality, & Virtual Meetings
Participants will receive the core 6-month weight loss program, the Bite Counter device to reduce dietary intake, access to the virtual reality platform for behavioral weight loss skills training, and the virtual meetings to support weight loss.
干预措施: Virtual Meetings (Behavioral)
结局指标
主要结局
Weight Change
时间窗: At baseline, 3-, and 6-months after initiating the program
The difference between initial weight and weight at the follow-up assessments. Patients will be asked to step on a scale at the assessment clinic.
次要结局
- Structured Weekly Moderate-to-Vigorous Physical Activity Minutes(At baseline, 3-, and 6-months after initiating the program)
- Number of Bites(At baseline, 3-, and 6-months after initiating the program)
- Weight Control Practices(At baseline, 3-, and 6-months after initiating the program)
- Weight Loss Self-Efficacy: Weight Efficacy Lifestyle Questionnaire(At baseline, 3-, and 6-months after initiating the program)