Cardiovascular DiseasesNCT03845283
Creating an Optimized Technology-Based Weight Loss Program for Cardiac Rehabilitation Patients
A study testing Online Behavioral Weight Loss Program, Physical Activity Intervention and Bite Counter in people with Cardiovascular Diseases and Obesity, run by The Miriam Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Cardiovascular Diseases, Obesity
- What is being tested?
- Online Behavioral Weight Loss Program, Physical Activity Intervention and Bite Counter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2019to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
About this study
Official title: Optimization and Evaluation of a Tailored Behavioral eHealth/mHealth Weight Loss Intervention for Cardiac Rehabilitation Patients Using the Multiphase Optimization Strategy
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.
- Conditions
- Cardiovascular Diseases, Obesity
- Being tested
- Online Behavioral Weight Loss Program, Physical Activity Intervention, Bite Counter, Virtual Reality, Virtual Meetings
- Keywords
- Cardiovascular Diseases, Obesity, Multiphase Optimization Strategy, Technology, Weight Loss, Cardiac Rehabilitation
- Medical subject headings
- Cardiovascular Diseases, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Behavioral Weight Loss ProgramBehavioural
A self-guided, online program that helps participants reduce excess calories and gradually increase physical activity.
Physical Activity InterventionBehavioural
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 CounterBehavioural
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 RealityBehavioural
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 MeetingsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity | Experimental | Participants will receive the core 6-month weight loss program and the tailored intervention to promote structured physical activity. Receives: Behavioral: Online Behavioral Weight Loss Program; Behavioral: Physical Activity Intervention |
| Core Program | Experimental | 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. Receives: Behavioral: Online Behavioral Weight Loss Program |
| Physical Activity & Virtual Meetings | Experimental | 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. Receives: Behavioral: Online Behavioral Weight Loss Program; Behavioral: Physical Activity Intervention; Behavioral: Virtual Meetings |
| Virtual Meetings | Experimental | Participants will receive the core 6-month weight loss program and the virtual meetings to support weight loss. Receives: Behavioral: Online Behavioral Weight Loss Program; Behavioral: Virtual Meetings |
| Physical Activity & Virtual Reality | Experimental | 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. Receives: Behavioral: Online Behavioral Weight Loss Program; Behavioral: Physical Activity Intervention; Behavioral: Virtual Reality |
| Virtual Reality | Experimental | Participants will receive the core 6-month weight loss program and access to the virtual reality platform for behavioral weight loss skills training. Receives: Behavioral: Online Behavioral Weight Loss Program; Behavioral: Virtual Reality |
| Physical Activity, Virtual Reality, & Virtual Meetings | Experimental | 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. Receives: Behavioral: Online Behavioral Weight Loss Program; Behavioral: Physical Activity Intervention; Behavioral: Virtual Reality; Behavioral: Virtual Meetings |
| Virtual Reality & Virtual Meetings | Experimental | 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. Receives: Behavioral: Online Behavioral Weight Loss Program; Behavioral: Virtual Reality; Behavioral: Virtual Meetings |
| Physical Activity & Bite Counter | Experimental | 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. Receives: Behavioral: Online Behavioral Weight Loss Program; Behavioral: Physical Activity Intervention; Behavioral: Bite Counter |
| Bite Counter | Experimental | Participants will receive the core 6-month weight loss program and the Bite Counter device to reduce dietary intake. Receives: Behavioral: Online Behavioral Weight Loss Program; Behavioral: Bite Counter |
| Physical Activity, Bite Counter, & Virtual Meetings | Experimental | 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. Receives: Behavioral: Online Behavioral Weight Loss Program; Behavioral: Physical Activity Intervention; Behavioral: Bite Counter; Behavioral: Virtual Meetings |
| Bite Counter & Virtual Meetings | Experimental | 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. Receives: Behavioral: Online Behavioral Weight Loss Program; Behavioral: Bite Counter; Behavioral: Virtual Meetings |
| Physical Activity, Bite Counter, & Virtual Reality | Experimental | 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. Receives: Behavioral: Online Behavioral Weight Loss Program; Behavioral: Physical Activity Intervention; Behavioral: Bite Counter; Behavioral: Virtual Reality |
| Bite Counter & Virtual Reality | Experimental | 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. Receives: Behavioral: Online Behavioral Weight Loss Program; Behavioral: Bite Counter; Behavioral: Virtual Reality |
| Physical Activity, Bite Counter, Virtual Reality & Meetings | Experimental | 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. Receives: Behavioral: Online Behavioral Weight Loss Program; Behavioral: Physical Activity Intervention; Behavioral: Bite Counter; Behavioral: Virtual Reality; Behavioral: Virtual Meetings |
| Bite Counter, Virtual Reality, & Virtual Meetings | Experimental | 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. Receives: Behavioral: Online Behavioral Weight Loss Program; Behavioral: Bite Counter; Behavioral: Virtual Reality; Behavioral: Virtual Meetings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, 3-, and 6-months after initiating the program
Secondary outcomes (4)
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.
Measured: At baseline, 3-, and 6-months after initiating the program
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.
Measured: At baseline, 3-, and 6-months after initiating the program
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.
Measured: At baseline, 3-, and 6-months after initiating the program
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.
Measured: At baseline, 3-, and 6-months after initiating the program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start2 May 2019
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845283
- Sponsor's protocol ID
- K23HL136845
- Other IDs
- K23HL136845
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2019
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization and Evaluation of a Tailored Behavioral eHealth/mHealth Weight Loss Intervention for Cardiac Rehabilitation Patients Using the Multiphase Optimization Strategy
- ClinicalTrials.gov ID
- NCT03845283
- Acronym / sponsor ID
- K23HL136845
- Conditions
- Cardiovascular Diseases, Obesity
- Keywords
- Cardiovascular Diseases, Obesity, Multiphase Optimization Strategy, Technology, Weight Loss, Cardiac Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 2 May 2019 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Physical Activity | Experimental | Behavioral: Online Behavioral Weight Loss Program, Behavioral: Physical Activity InterventionParticipants will receive the core 6-month weight loss program and the tailored intervention to promote structured physical activity. |
| Core Program | Experimental | Behavioral: Online Behavioral Weight Loss ProgramParticipants 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 | Experimental | Behavioral: Online Behavioral Weight Loss Program, Behavioral: Physical Activity Intervention, Behavioral: Virtual MeetingsParticipants 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 | Experimental | Behavioral: Online Behavioral Weight Loss Program, Behavioral: Virtual MeetingsParticipants will receive the core 6-month weight loss program and the virtual meetings to support weight loss. |
| Physical Activity & Virtual Reality | Experimental | Behavioral: Online Behavioral Weight Loss Program, Behavioral: Physical Activity Intervention, Behavioral: Virtual RealityParticipants 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 | Experimental | Behavioral: Online Behavioral Weight Loss Program, Behavioral: Virtual RealityParticipants 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 | Experimental | Behavioral: Online Behavioral Weight Loss Program, Behavioral: Physical Activity Intervention, Behavioral: Virtual Reality, Behavioral: Virtual MeetingsParticipants 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 | Experimental | Behavioral: Online Behavioral Weight Loss Program, Behavioral: Virtual Reality, Behavioral: Virtual MeetingsParticipants 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 | Experimental | Behavioral: Online Behavioral Weight Loss Program, Behavioral: Physical Activity Intervention, Behavioral: Bite CounterParticipants 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 | Experimental | Behavioral: Online Behavioral Weight Loss Program, Behavioral: Bite CounterParticipants will receive the core 6-month weight loss program and the Bite Counter device to reduce dietary intake. |
| Physical Activity, Bite Counter, & Virtual Meetings | Experimental | Behavioral: Online Behavioral Weight Loss Program, Behavioral: Physical Activity Intervention, Behavioral: Bite Counter, Behavioral: Virtual MeetingsParticipants 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 | Experimental | Behavioral: Online Behavioral Weight Loss Program, Behavioral: Bite Counter, Behavioral: Virtual MeetingsParticipants 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 | Experimental | Behavioral: Online Behavioral Weight Loss Program, Behavioral: Physical Activity Intervention, Behavioral: Bite Counter, Behavioral: Virtual RealityParticipants 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 | Experimental | Behavioral: Online Behavioral Weight Loss Program, Behavioral: Bite Counter, Behavioral: Virtual RealityParticipants 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 | Experimental | Behavioral: Online Behavioral Weight Loss Program, Behavioral: Physical Activity Intervention, Behavioral: Bite Counter, Behavioral: Virtual Reality, Behavioral: Virtual MeetingsParticipants 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 | Experimental | Behavioral: Online Behavioral Weight Loss Program, Behavioral: Bite Counter, Behavioral: Virtual Reality, Behavioral: Virtual MeetingsParticipants 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Behavioral Weight Loss ProgramA self-guided, online program that helps participants reduce excess calories and gradually increase physical activity. | Behavioural | Bite Counter, Bite Counter & Virtual Meetings, Bite Counter & Virtual Reality, Bite Counter, Virtual Reality, & Virtual Meetings, Core Program, Physical Activity, Physical Activity & Bite Counter, Physical Activity & Virtual Meetings, Physical Activity & Virtual Reality, Physical Activity, Bite Counter, & Virtual Meetings, Physical Activity, Bite Counter, & Virtual Reality, Physical Activity, Bite Counter, Virtual Reality & Meetings, Physical Activity, Virtual Reality, & Virtual Meetings, Virtual Meetings, Virtual Reality, Virtual Reality & Virtual Meetings |
| Physical Activity InterventionAn 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. | Behavioural | Physical Activity, Physical Activity & Bite Counter, Physical Activity & Virtual Meetings, Physical Activity & Virtual Reality, Physical Activity, Bite Counter, & Virtual Meetings, Physical Activity, Bite Counter, & Virtual Reality, Physical Activity, Bite Counter, Virtual Reality & Meetings, Physical Activity, Virtual Reality, & Virtual Meetings |
| Bite CounterParticipants 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. | Behavioural | Bite Counter, Bite Counter & Virtual Meetings, Bite Counter & Virtual Reality, Bite Counter, Virtual Reality, & Virtual Meetings, Physical Activity & Bite Counter, Physical Activity, Bite Counter, & Virtual Meetings, Physical Activity, Bite Counter, & Virtual Reality, Physical Activity, Bite Counter, Virtual Reality & Meetings |
| Virtual RealityThis 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. | Behavioural | Bite Counter & Virtual Reality, Bite Counter, Virtual Reality, & Virtual Meetings, Physical Activity & Virtual Reality, Physical Activity, Bite Counter, & Virtual Reality, Physical Activity, Bite Counter, Virtual Reality & Meetings, Physical Activity, Virtual Reality, & Virtual Meetings, Virtual Reality, Virtual Reality & Virtual Meetings |
| Virtual MeetingsParticipants 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. | Behavioural | Bite Counter & Virtual Meetings, Bite Counter, Virtual Reality, & Virtual Meetings, Physical Activity & Virtual Meetings, Physical Activity, Bite Counter, & Virtual Meetings, Physical Activity, Bite Counter, Virtual Reality & Meetings, Physical Activity, Virtual Reality, & Virtual Meetings, Virtual Meetings, Virtual Reality & Virtual Meetings |
Primary outcome
Weight Change
Time frame: 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.
4 secondary outcomes
Structured Weekly Moderate-to-Vigorous Physical Activity Minutes
Time frame: At baseline, 3-, and 6-months after initiating the program
Number of Bites
Time frame: At baseline, 3-, and 6-months after initiating the program
Weight Control Practices
Time frame: At baseline, 3-, and 6-months after initiating the program
Weight Loss Self-Efficacy: Weight Efficacy Lifestyle Questionnaire
Time frame: At baseline, 3-, and 6-months after initiating the program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Behavioral Weight Loss Program, Physical Activity Intervention and Bite Counter in people with Cardiovascular Diseases and Obesity, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Change (time frame: At baseline, 3-, and 6-months after initiating the program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.