Clinical trial NCT04658550: Remote vs In Person Weight Loss Study
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese patients with Body Mass Index \> 35 Kg/m2 and enrolled in the behaviour modification program for weight loss at the Bariatric Centre of Excellence at 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.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* Enrolled in 26-week BCoE behaviour modification program with meal replacements
* Able and willing to provide signed informed consent

Exclusion Criteria:

- Subjects will be excluded if they contact clinic or study personnel to withdraw consent or withdraw data from the study.

Primary outcomes:
measure: Mean Percentage Change in Body Weight
timeFrame: Baseline to Week 26
Secondary outcomes:
measure: Patient satisfaction and barriers to participation
timeFrame: Week 26
measure: Change in blood pressure
timeFrame: Baseline to Week 26
measure: Change in lipid profile
timeFrame: Baseline to Week 26
measure: Change in fasting blood glucose
timeFrame: Baseline to Week 26
measure: Change in heart rate
timeFrame: Baseline to Week 26
measure: Change in HbA1C
timeFrame: Baseline to Week 26
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare Hamilton
name: Tony Chetty, MD
role: PRINCIPAL_INVESTIGATOR
References: