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Behavioral Intervention

Technology-Based Weight Loss for Cardiovascular Disease

N/A
Waitlist Available
Research Sponsored by The Miriam Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Weight loss of ≥ 5% of body weight in the past 6 months
Physician prescription for 24 hours of oxygen therapy daily
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, 3-, and 6-months after initiating the program
Awards & highlights

Summary

This trial aims to improve outcomes for individuals with cardiovascular disease by incorporating weight loss interventions into cardiac rehabilitation. The study will test the effectiveness of different components such as Fitbit, bite counting device, virtual reality

Who is the study for?
This trial is for cardiac rehabilitation patients with a BMI of 27-45, who are currently in outpatient phase II programs at The Miriam or Newport Hospital. They must have medical clearance, home internet access, and be comfortable using English and technology for weight loss.Check my eligibility
What is being tested?
The study tests if adding tech like Fitbits, bite counters, VR interventions, and virtual meetings to an online weight loss program helps cardiac rehab patients lose more weight. Participants will randomly receive different combinations of these tools to see which work best.See study design
What are the potential side effects?
Since this trial involves non-invasive technology and behavioral changes rather than medication, side effects may include discomfort from wearing devices or frustration with the technology. Physical activity could cause typical exercise-related strain.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have lost 5% or more of my body weight in the last 6 months.
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My doctor has prescribed me oxygen therapy all day.
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I am currently taking medication to lose weight.
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I have the most severe form of heart failure.
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My doctor has diagnosed me with dementia.
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I am currently undergoing dialysis.
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I can't walk a block without stopping.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, 3-, and 6-months after initiating the program
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, 3-, and 6-months after initiating the program for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Weight Change
Secondary outcome measures
Number of Bites
Structured Weekly Moderate-to-Vigorous Physical Activity Minutes
Weight Control Practices
+1 more
Other outcome measures
Overall Behavioral Self-Management in Cardiac Rehabilitation

Trial Design

16Treatment groups
Experimental Treatment
Group I: Virtual Reality & Virtual MeetingsExperimental Treatment3 Interventions
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.
Group II: Virtual RealityExperimental Treatment2 Interventions
Participants will receive the core 6-month weight loss program and access to the virtual reality platform for behavioral weight loss skills training.
Group III: Virtual MeetingsExperimental Treatment2 Interventions
Participants will receive the core 6-month weight loss program and the virtual meetings to support weight loss.
Group IV: Physical Activity, Virtual Reality, & Virtual MeetingsExperimental Treatment4 Interventions
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.
Group V: Physical Activity, Bite Counter, Virtual Reality & MeetingsExperimental Treatment5 Interventions
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.
Group VI: Physical Activity, Bite Counter, & Virtual RealityExperimental Treatment4 Interventions
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.
Group VII: Physical Activity, Bite Counter, & Virtual MeetingsExperimental Treatment4 Interventions
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.
Group VIII: Physical Activity & Virtual RealityExperimental Treatment3 Interventions
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.
Group IX: Physical Activity & Virtual MeetingsExperimental Treatment3 Interventions
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.
Group X: Physical Activity & Bite CounterExperimental Treatment3 Interventions
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.
Group XI: Physical ActivityExperimental Treatment2 Interventions
Participants will receive the core 6-month weight loss program and the tailored intervention to promote structured physical activity.
Group XII: Core ProgramExperimental Treatment1 Intervention
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.
Group XIII: Bite Counter, Virtual Reality, & Virtual MeetingsExperimental Treatment4 Interventions
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.
Group XIV: Bite Counter & Virtual RealityExperimental Treatment3 Interventions
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.
Group XV: Bite Counter & Virtual MeetingsExperimental Treatment3 Interventions
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.
Group XVI: Bite CounterExperimental Treatment2 Interventions
Participants will receive the core 6-month weight loss program and the Bite Counter device to reduce dietary intake.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bite Counter
2015
Completed Phase 1
~130
Virtual Reality
2017
Completed Phase 3
~1630
Physical Activity Intervention
2020
N/A
~990
Online Behavioral Weight Loss Program
2021
Completed Phase 3
~480

Find a Location

Who is running the clinical trial?

The Miriam HospitalLead Sponsor
241 Previous Clinical Trials
37,390 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,854 Previous Clinical Trials
47,817,674 Total Patients Enrolled
~3 spots leftby Sep 2024