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

Not Applicable

Active, not recruiting

• Conditions: Obesity; Cardiovascular Diseases

• Registration Number: NCT03845283
• Lead Sponsor: The Miriam Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-05
• Study First Submitted QC: 2019-02-15
• Study First Posted: 2019-02-19
• Study Start: 2019-05-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-05-19
• Last Update Posted: 2024-05-21
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 198

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Weight Change	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.

Secondary Outcome Measures

Name	Time	Method
Structured Weekly Moderate-to-Vigorous Physical Activity Minutes	At baseline, 3-, and 6-months after initiating the program	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	At baseline, 3-, and 6-months after initiating the program	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	At baseline, 3-, and 6-months after initiating the program	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	At baseline, 3-, and 6-months after initiating the program	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.

Trial Locations

Locations (1)

The Weight Control and Diabetes Research Center; 🇺🇸 Providence, Rhode Island, United States