Clinical trial NCT03845283: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Obesity
Keywords: Cardiovascular Diseases
Obesity
Multiphase Optimization Strategy
Technology
Weight Loss
Cardiac Rehabilitation
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-02-19
Enrollment: 198
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Weight Change
timeFrame: At baseline, 3-, and 6-months after initiating the program
Secondary outcomes:
measure: Structured Weekly Moderate-to-Vigorous Physical Activity Minutes
timeFrame: At baseline, 3-, and 6-months after initiating the program
measure: Number of Bites
timeFrame: At baseline, 3-, and 6-months after initiating the program
measure: Weight Control Practices
timeFrame: At baseline, 3-, and 6-months after initiating the program
measure: Weight Loss Self-Efficacy: Weight Efficacy Lifestyle Questionnaire
timeFrame: At baseline, 3-, and 6-months after initiating the program
Other outcomes:
measure: Overall Behavioral Self-Management in Cardiac Rehabilitation
timeFrame: At baseline, 3-, and 6-months after initiating the program
Locations:
city: Providence
country: United States
facility: The Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
References: