Remote vs In Person Weight Loss Study
- Conditions
- Obesity
- Interventions
- Other: Remote Behaviour Modification ProgramOther: In Person Behaviour Modification Program
- Registration Number
- NCT04658550
- Lead Sponsor
- St. Joseph's Healthcare Hamilton
- Brief Summary
The COVID-19 pandemic has created fear, financial difficulties and interruptions in the lives of patients and healthcare providers. As a result, many patients suffering from chronic conditions such as obesity have had their treatment disrupted by the pandemic. The Bariatric Medical Weight Management Clinic at St. Joseph's Healthcare Hamilton transitioned its weight loss and maintenance counselling classes to a remote (online) platform in response to the pandemic. The remote weight loss and maintenance classes allows patients to continue receiving treatment for obesity from their homes. The remote weight loss and maintenance program is conducted on a safe platform that has been thoroughly reviewed and approved by St. Joseph's Privacy Committees.
The aim of this study is to learn whether the remote weight loss and maintenance classes can lead to similar weight loss compared to the in-person weight loss and maintenance classes that were offered to patients before the COVID-19 pandemic. This study also aims to gather feedback about the program to improve its delivery and patients' experiences.
- Detailed Description
The COVID-19 pandemic has created fear, financial difficulties and interruptions in the lives of patients and healthcare providers. As a result, many patients suffering from chronic conditions such as obesity have had their treatment disrupted by the pandemic. The Bariatric Medical Weight Management Clinic at St. Joseph's Healthcare Hamilton transitioned its behaviour modification program, also known as weight loss and maintenance counselling classes, to a remote (online) platform in response to the pandemic. The remote weight loss and maintenance classes allow patients to continue receiving treatment for obesity from their homes.
This is a 26-week, single-centre, mixed retrospective and prospective, observational study evaluating the efficacy of counselling in a remote setting compared to an in-person setting in achieving weight loss among adult patients with obesity enrolled in the behaviour modification program. This study also aims to gather feedback about the program to improve its delivery and patients' experiences.
Approximately 120 patients participating in the behaviour modification program and providing informed consent will be observed in this study. This study involves a prospective and retrospective component. The prospective component will be an observational study of 60 subjects who will receive 26-weeks of weight loss and maintenance counselling in a remote setting and a low-calorie meal replacement as part of their usual care. The retrospective component will involve using historical data from 60 subjects who received 26-weeks of weight loss and maintenance counselling in an in-person setting and a low-calorie meal replacement as part of their usual care.
Parameters measured as part of standard of care at the start and end of the program, such as body weight, blood pressure and lab tests will be collected for analysis of study endpoints. Participants will also be asked to complete a satisfaction survey at the end. There will be no blinding of patients, study investigators, or data analysts.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 77
- ≥ 18 years of age
- Enrolled in 26-week BCoE behaviour modification program with meal replacements
- Able and willing to provide signed informed consent
- Subjects will be excluded if they contact clinic or study personnel to withdraw consent or withdraw data from the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Remote Weight Loss Behaviour Modification Program with Meal Replacements Remote Behaviour Modification Program This is the prospective study group who will receive 26-weeks of weight loss and maintenance counselling in a remote setting and a low-calorie meal replacement as part of their usual care. In Person Weight Bahaviour Modification Program with Meal Replacements In Person Behaviour Modification Program This is the retrospective study group who received 26-weeks of weight loss and maintenance counselling in person and a low-calorie meal replacement as part of their usual care.
- Primary Outcome Measures
Name Time Method Mean Percentage Change in Body Weight Baseline to Week 26 To evaluate the efficacy of counselling in a remote setting compared to an in-person setting in achieving weight loss among adult patients with obesity enrolled in the behaviour modification program
- Secondary Outcome Measures
Name Time Method Change in heart rate Baseline to Week 26 Change in heart rate
Patient satisfaction and barriers to participation Week 26 Patient satisfaction and barriers to participation associated with the remote weight loss and maintenance program as assessed by the Bariatric Centre of Excellence Virtual Medical Program Satisfaction Survey.
Change in HbA1C Baseline to Week 26 Change in HbA1C
Change in blood pressure Baseline to Week 26 Change in blood pressure
Change in lipid profile Baseline to Week 26 Change in lipid profile including total cholesterol, triglycerides, low density lipoprotein and high density lipoprotein
Change in fasting blood glucose Baseline to Week 26 Change in fasting blood glucose
Trial Locations
- Locations (1)
St Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada