St Joseph's Healthcare Hamilton
Hamilton, Ontario, L9C0E3, Canada
NCT Number: NCT04658550
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Hamilton, Ontario, L9C0E3, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The standard of care behaviour modification program for weight loss will be offered virtually due to the COVID-19 pandemic (prospective).
The standard of care behaviour modification program for weight loss was offered in person prior to the COVID-19 pandemic (retrospective).
Time frame: 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
Time frame: 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.
Time frame: Baseline to Week 26
Change in blood pressure
Time frame: Baseline to Week 26
Change in lipid profile including total cholesterol, triglycerides, low density lipoprotein and high density lipoprotein
Time frame: Baseline to Week 26
Change in fasting blood glucose
Time frame: Baseline to Week 26
Change in heart rate
Time frame: Baseline to Week 26
Change in HbA1C
St. Joseph's Healthcare Hamilton
Other
A Mixed Retrospective-prospective, Observational Study Evaluating the Efficacy of Counselling in a Remote Setting Compared to an In-person Setting on Weight Loss, in Obese Patients With Body Mass Index > 35 Kg/m2 and Enrolled in the Behaviour Modification Program at the Bariatric Centre of Excellence at St Joseph's Healthcare Hamilton.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05742165
Behavior, Body Weight
New York, United States
View Trial DetailsNCT05882045
Body Weight, Cardiovascular Diseases
Phoenix, Arizona, United States
View Trial DetailsNCT05929079
Apnea, Body Weight
Anniston, Alabama, United States
View Trial DetailsNCT00342732
Body Weight, Nutrition Disorders
Phoenix, Arizona, United States
View Trial Details