Creating an Optimized Technology-Based Weight Loss Program for Cardiac Rehabilitation Patients

Obesity Clinical Trial

Official title:

Optimization and Evaluation of a Tailored Behavioral eHealth/mHealth Weight Loss Intervention for Cardiac Rehabilitation Patients Using the Multiphase Optimization Strategy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03845283
• Other study ID #: K23HL136845
• Secondary ID: K23HL136845
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2, 2019
• Est. completion date: September 1, 2024

Study information

• Verified date: February 2024
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 199
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Obesity
• Weight Loss

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	The Weight Control and Diabetes Research Center	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall Behavioral Self-Management in Cardiac Rehabilitation	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.	At baseline, 3-, and 6-months after initiating the program
Primary	Weight Change	The difference between initial weight and weight at the follow-up assessments. Patients will be asked to step on a scale at the assessment clinic.	At baseline, 3-, and 6-months after initiating the program
Secondary	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.	At baseline, 3-, and 6-months after initiating the program
Secondary	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.	At baseline, 3-, and 6-months after initiating the program
Secondary	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.	At baseline, 3-, and 6-months after initiating the program
Secondary	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.	At baseline, 3-, and 6-months after initiating the program