Creating an Optimized Technology-Based Weight Loss Program for Cardiac Rehabilitation Patients
Optimization and Evaluation of a Tailored Behavioral eHealth/mHealth Weight Loss Intervention for Cardiac Rehabilitation Patients Using the Multiphase Optimization Strategy
1 other identifier
interventional
198
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cardiovascular-diseases
Started May 2019
Longer than P75 for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2019
CompletedFirst Posted
Study publicly available on registry
February 19, 2019
CompletedStudy Start
First participant enrolled
May 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedMay 21, 2024
February 1, 2024
5.3 years
February 5, 2019
May 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight Change
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.
At baseline, 3-, and 6-months after initiating the program
Secondary Outcomes (4)
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
Other Outcomes (1)
Overall Behavioral Self-Management in Cardiac Rehabilitation
At baseline, 3-, and 6-months after initiating the program
Study Arms (16)
Physical Activity
EXPERIMENTALParticipants will receive the core 6-month weight loss program and the tailored intervention to promote structured physical activity.
Core Program
EXPERIMENTALParticipants 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.
Physical Activity & Virtual Meetings
EXPERIMENTALParticipants 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.
Virtual Meetings
EXPERIMENTALParticipants will receive the core 6-month weight loss program and the virtual meetings to support weight loss.
Physical Activity & Virtual Reality
EXPERIMENTALParticipants 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.
Virtual Reality
EXPERIMENTALParticipants will receive the core 6-month weight loss program and access to the virtual reality platform for behavioral weight loss skills training.
Physical Activity, Virtual Reality, & Virtual Meetings
EXPERIMENTALParticipants 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.
Virtual Reality & Virtual Meetings
EXPERIMENTALParticipants 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.
Physical Activity & Bite Counter
EXPERIMENTALParticipants 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.
Bite Counter
EXPERIMENTALParticipants will receive the core 6-month weight loss program and the Bite Counter device to reduce dietary intake.
Physical Activity, Bite Counter, & Virtual Meetings
EXPERIMENTALParticipants 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.
Bite Counter & Virtual Meetings
EXPERIMENTALParticipants 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.
Physical Activity, Bite Counter, & Virtual Reality
EXPERIMENTALParticipants 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.
Bite Counter & Virtual Reality
EXPERIMENTALParticipants 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.
Physical Activity, Bite Counter, Virtual Reality & Meetings
EXPERIMENTALParticipants 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.
Bite Counter, Virtual Reality, & Virtual Meetings
EXPERIMENTALParticipants 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.
Interventions
A self-guided, online program that helps participants reduce excess calories and gradually increase physical activity.
An program designed to help participants gradually increase their physical activity and maintain an active lifestyle. The program encourages bouts of moderate-to-vigorous physical activity. Participants in this group will receive a Fitbit Versa to help them monitor their physical activity that they will be advised to wear daily. Participants will receive brief (5-10 minute) lessons weekly for the first 3 months and monthly for the last 3 months.
Participants will receive a Bite Counter device to help them monitor and reduce their within-meal consumption. Participants will be asked to wear the device daily.
This program allows participants to practice behavioral weight loss skills using a virtual reality system compatible with their home device. This program helps patients practice these skills in the following artificial settings: at home, at work, at the gym, and at a party. Each participant will be asked to play through each scene at least once during their participation, though they are encouraged to use the program regularly.
Participants will attend virtual meetings using their own device. Each virtual meeting focuses on a specific topic that will help patients lose weight. Participants are asked to virtually attend at least 6 meetings during their participation. There is no limit to how many they can attend. The meeting topics will rotate and repeat on a schedule.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2019
First Posted
February 19, 2019
Study Start
May 2, 2019
Primary Completion
September 1, 2024
Study Completion
September 1, 2024
Last Updated
May 21, 2024
Record last verified: 2024-02