Creating an Optimized Technology-Based Weight Loss Program for Cardiac Rehabilitation Patients
NCT ID: NCT03845283
Last Updated: 2024-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
198 participants
INTERVENTIONAL
2019-05-02
2024-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Energy Balancing Modeling and Mobile Technology to Support e-Weight Loss
NCT02857595
Targeting Obesity to Optimize Health in Cardiac Rehab (TOPCARE)
NCT03423238
Comparison of Weight Loss Programs for Individuals With Severe Obesity
NCT01330329
Innovative Technology To Improve Patient Adherence To Weight Loss Recommendations
NCT01222858
Passive Sensing Technology for Lapse Measurement
NCT03739151
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Physical Activity
Participants will receive the core 6-month weight loss program and the tailored intervention to promote structured physical activity.
Online Behavioral Weight Loss Program
A self-guided, online program that helps participants reduce excess calories and gradually increase physical activity.
Physical Activity Intervention
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.
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.
Online Behavioral Weight Loss Program
A self-guided, online program that helps participants reduce excess calories and gradually increase physical activity.
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.
Online Behavioral Weight Loss Program
A self-guided, online program that helps participants reduce excess calories and gradually increase physical activity.
Physical Activity Intervention
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.
Virtual Meetings
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.
Virtual Meetings
Participants will receive the core 6-month weight loss program and the virtual meetings to support weight loss.
Online Behavioral Weight Loss Program
A self-guided, online program that helps participants reduce excess calories and gradually increase physical activity.
Virtual Meetings
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.
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.
Online Behavioral Weight Loss Program
A self-guided, online program that helps participants reduce excess calories and gradually increase physical activity.
Physical Activity Intervention
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.
Virtual Reality
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.
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.
Online Behavioral Weight Loss Program
A self-guided, online program that helps participants reduce excess calories and gradually increase physical activity.
Virtual Reality
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.
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.
Online Behavioral Weight Loss Program
A self-guided, online program that helps participants reduce excess calories and gradually increase physical activity.
Physical Activity Intervention
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.
Virtual Reality
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.
Virtual Meetings
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.
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.
Online Behavioral Weight Loss Program
A self-guided, online program that helps participants reduce excess calories and gradually increase physical activity.
Virtual Reality
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.
Virtual Meetings
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.
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.
Online Behavioral Weight Loss Program
A self-guided, online program that helps participants reduce excess calories and gradually increase physical activity.
Physical Activity Intervention
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.
Bite Counter
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.
Bite Counter
Participants will receive the core 6-month weight loss program and the Bite Counter device to reduce dietary intake.
Online Behavioral Weight Loss Program
A self-guided, online program that helps participants reduce excess calories and gradually increase physical activity.
Bite Counter
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.
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.
Online Behavioral Weight Loss Program
A self-guided, online program that helps participants reduce excess calories and gradually increase physical activity.
Physical Activity Intervention
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.
Bite Counter
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.
Virtual Meetings
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.
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.
Online Behavioral Weight Loss Program
A self-guided, online program that helps participants reduce excess calories and gradually increase physical activity.
Bite Counter
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.
Virtual Meetings
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.
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.
Online Behavioral Weight Loss Program
A self-guided, online program that helps participants reduce excess calories and gradually increase physical activity.
Physical Activity Intervention
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.
Bite Counter
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.
Virtual Reality
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.
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.
Online Behavioral Weight Loss Program
A self-guided, online program that helps participants reduce excess calories and gradually increase physical activity.
Bite Counter
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.
Virtual Reality
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.
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.
Online Behavioral Weight Loss Program
A self-guided, online program that helps participants reduce excess calories and gradually increase physical activity.
Physical Activity Intervention
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.
Bite Counter
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.
Virtual Reality
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.
Virtual Meetings
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.
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.
Online Behavioral Weight Loss Program
A self-guided, online program that helps participants reduce excess calories and gradually increase physical activity.
Bite Counter
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.
Virtual Reality
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.
Virtual Meetings
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Online Behavioral Weight Loss Program
A self-guided, online program that helps participants reduce excess calories and gradually increase physical activity.
Physical Activity Intervention
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.
Bite Counter
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.
Virtual Reality
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.
Virtual Meetings
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
21 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
The Miriam Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Weight Control and Diabetes Research Center
Providence, Rhode Island, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Other Identifiers
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.