NCT03845283

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: The Miriam Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Diseases
• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Online Behavioral Weight Loss Program	A self-guided, online program that helps participants reduce excess calories and gradually increase physical activity.
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2019-05-02
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2019-02-19
• Last updated: 2024-05-21

Locations

1 site across 1 country: United States