Back to resultsCreating an Optimized Technology-Based Weight Loss Program for Cardiac Rehabilitation Patients
Primary Purpose
Cardiovascular Diseases, Obesity
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online Behavioral Weight Loss Program
Physical Activity Intervention
Bite Counter
Virtual Reality
Virtual Meetings
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Diseases focused on measuring Cardiovascular Diseases, Obesity, Multiphase Optimization Strategy, Technology, Weight Loss, Cardiac Rehabilitation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- The Weight Control and Diabetes Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm 15
Arm 16
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Physical Activity
Core Program
Physical Activity & Virtual Meetings
Virtual Meetings
Physical Activity & Virtual Reality
Virtual Reality
Physical Activity, Virtual Reality, & Virtual Meetings
Virtual Reality & Virtual Meetings
Physical Activity & Bite Counter
Bite Counter
Physical Activity, Bite Counter, & Virtual Meetings
Bite Counter & Virtual Meetings
Physical Activity, Bite Counter, & Virtual Reality
Bite Counter & Virtual Reality
Physical Activity, Bite Counter, Virtual Reality & Meetings
Bite Counter, Virtual Reality, & Virtual Meetings
Arm Description
Participants will receive the core 6-month weight loss program and the tailored intervention to promote structured physical activity.
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.
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.
Participants will receive the core 6-month weight loss program and the virtual meetings to support weight loss.
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.
Participants will receive the core 6-month weight loss program and access to the virtual reality platform for behavioral weight loss skills training.
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.
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.
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.
Participants will receive the core 6-month weight loss program and the Bite Counter device to reduce dietary intake.
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.
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.
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Structured Weekly Moderate-to-Vigorous Physical Activity Minutes
Structured MVPA minutes will be measured via a SenseWear Armband monitor (BodyMedia, Inc, Pittsburgh PA, USA). This multi-sensor monitor worn on the upper triceps wirelessly integrates motion data from a triaxial accelerometer with other sensors to estimate energy expenditure and activity intensity. Everyone will be asked to wear the armband during waking hours across the 7-day period prior to each assessment. Participants will be required to provide at least 5 days of data (including 1 weekend day), defined as ≥ 600 min during the hours of 7 am to 11 pm, to be included in analyses.
Number of Bites
All study participants' average number of recorded daily bites of food over 7 consecutive days will be assessed by a Bite Counter (Bite Technologies, Pendleton SC, USA) with the display inactivated. Participants' average number of daily bites will be compared from each 7-day period prior to each assessment.
Weight Control Practices
The validated, widely-used Weight Control Practices Scale measures the health behaviors an individual executes to influence energy balance and is targeted by the VR program. All participants will complete this measure at each assessment point. The overall scale scores range from 0-30 where higher scores indicate that the participant is using more strategies to control their weight. The subscale scores, which assess dietary choices (score range 0-10), self-monitoring strategies (score range 0-8), physical activity (score range 0-6), and psychological coping (score range 0-7), will also be examined. Higher scores on the subscales indicate greater weight control (which is a better outcome). Subscale scores are summed to compute the total scale score.
Weight Loss Self-Efficacy: Weight Efficacy Lifestyle Questionnaire
This is the participant's confidence in implementing BWL skills. It will be targeted by the virtual meetings and will be measured via the well-validated Weight Efficacy Lifestyle Questionnaire in all participants. The scores can range from 0-180 where higher scores indicate more weight loss self-efficacy and better outcomes.
Full Information
NCT ID
NCT03845283
First Posted
February 5, 2019
Last Updated
September 2, 2021
Sponsor
The Miriam Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT03845283
Brief Title
Creating an Optimized Technology-Based Weight Loss Program for Cardiac Rehabilitation Patients
Official Title
Optimization and Evaluation of a Tailored Behavioral eHealth/mHealth Weight Loss Intervention for Cardiac Rehabilitation Patients Using the Multiphase Optimization Strategy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2019 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Miriam Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Obesity
Keywords
Cardiovascular Diseases, Obesity, Multiphase Optimization Strategy, Technology, Weight Loss, Cardiac Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physical Activity
Arm Type
Experimental
Arm Description
Participants will receive the core 6-month weight loss program and the tailored intervention to promote structured physical activity.
Arm Title
Core Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Physical Activity & Virtual Meetings
Arm Type
Experimental
Arm Description
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.
Arm Title
Virtual Meetings
Arm Type
Experimental
Arm Description
Participants will receive the core 6-month weight loss program and the virtual meetings to support weight loss.
Arm Title
Physical Activity & Virtual Reality
Arm Type
Experimental
Arm Description
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.
Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
Participants will receive the core 6-month weight loss program and access to the virtual reality platform for behavioral weight loss skills training.
Arm Title
Physical Activity, Virtual Reality, & Virtual Meetings
Arm Type
Experimental
Arm Description
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.
Arm Title
Virtual Reality & Virtual Meetings
Arm Type
Experimental
Arm Description
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.
Arm Title
Physical Activity & Bite Counter
Arm Type
Experimental
Arm Description
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.
Arm Title
Bite Counter
Arm Type
Experimental
Arm Description
Participants will receive the core 6-month weight loss program and the Bite Counter device to reduce dietary intake.
Arm Title
Physical Activity, Bite Counter, & Virtual Meetings
Arm Type
Experimental
Arm Description
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.
Arm Title
Bite Counter & Virtual Meetings
Arm Type
Experimental
Arm Description
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.
Arm Title
Physical Activity, Bite Counter, & Virtual Reality
Arm Type
Experimental
Arm Description
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.
Arm Title
Bite Counter & Virtual Reality
Arm Type
Experimental
Arm Description
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.
Arm Title
Physical Activity, Bite Counter, Virtual Reality & Meetings
Arm Type
Experimental
Arm Description
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.
Arm Title
Bite Counter, Virtual Reality, & Virtual Meetings
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online Behavioral Weight Loss Program
Intervention Description
A self-guided, online program that helps participants reduce excess calories and gradually increase physical activity.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Bite Counter
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Meetings
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight Change
Description
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.
Time Frame
At baseline, 3-, and 6-months after initiating the program
Secondary Outcome Measure Information:
Title
Structured Weekly Moderate-to-Vigorous Physical Activity Minutes
Description
Structured MVPA minutes will be measured via a SenseWear Armband monitor (BodyMedia, Inc, Pittsburgh PA, USA). This multi-sensor monitor worn on the upper triceps wirelessly integrates motion data from a triaxial accelerometer with other sensors to estimate energy expenditure and activity intensity. Everyone will be asked to wear the armband during waking hours across the 7-day period prior to each assessment. Participants will be required to provide at least 5 days of data (including 1 weekend day), defined as ≥ 600 min during the hours of 7 am to 11 pm, to be included in analyses.
Time Frame
At baseline, 3-, and 6-months after initiating the program
Title
Number of Bites
Description
All study participants' average number of recorded daily bites of food over 7 consecutive days will be assessed by a Bite Counter (Bite Technologies, Pendleton SC, USA) with the display inactivated. Participants' average number of daily bites will be compared from each 7-day period prior to each assessment.
Time Frame
At baseline, 3-, and 6-months after initiating the program
Title
Weight Control Practices
Description
The validated, widely-used Weight Control Practices Scale measures the health behaviors an individual executes to influence energy balance and is targeted by the VR program. All participants will complete this measure at each assessment point. The overall scale scores range from 0-30 where higher scores indicate that the participant is using more strategies to control their weight. The subscale scores, which assess dietary choices (score range 0-10), self-monitoring strategies (score range 0-8), physical activity (score range 0-6), and psychological coping (score range 0-7), will also be examined. Higher scores on the subscales indicate greater weight control (which is a better outcome). Subscale scores are summed to compute the total scale score.
Time Frame
At baseline, 3-, and 6-months after initiating the program
Title
Weight Loss Self-Efficacy: Weight Efficacy Lifestyle Questionnaire
Description
This is the participant's confidence in implementing BWL skills. It will be targeted by the virtual meetings and will be measured via the well-validated Weight Efficacy Lifestyle Questionnaire in all participants. The scores can range from 0-180 where higher scores indicate more weight loss self-efficacy and better outcomes.
Time Frame
At baseline, 3-, and 6-months after initiating the program
Other Pre-specified Outcome Measures:
Title
Overall Behavioral Self-Management in Cardiac Rehabilitation
Description
All participants will complete a newly-developed self-management inventory designed specifically for cardiac rehabilitation patients. The total score can range from 54-300, with higher scores generally reflecting better self-management.
Time Frame
At baseline, 3-, and 6-months after initiating the program
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carly M Goldstein, PhD
Phone
4017938960
Email
carly.goldstein@lifespan.org
First Name & Middle Initial & Last Name or Official Title & Degree
John G Thomas, PhD
Email
jthomas4@lifespan.org
Facility Information:
Facility Name
The Weight Control and Diabetes Research Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carly M Goldstein, PhD
Phone
401-793-8960
Email
carly.goldstein@lifespan.org
First Name & Middle Initial & Last Name & Degree
Carly M Goldstein, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The raw data from the current project are too large to easily transfer to individual investigators. As such, the investigators plan to develop a cost-effective, safe plan for sharing de-identified participant data upon reasonable request by other researchers.
Learn more about this trial
Creating an Optimized Technology-Based Weight Loss Program for Cardiac Rehabilitation Patients
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