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Clinical Trials/NCT04658550
NCT04658550
Completed
Not Applicable

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.

St. Joseph's Healthcare Hamilton1 site in 1 country77 target enrollmentOctober 16, 2020
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
St. Joseph's Healthcare Hamilton
Enrollment
77
Locations
1
Primary Endpoint
Mean Percentage Change in Body Weight
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 16, 2020
End Date
December 31, 2021
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tony Chetty

Associate Professor Pathology and Molecular Medicine

St. Joseph's Healthcare Hamilton

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.

Outcomes

Primary Outcomes

Mean Percentage Change in Body Weight

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

Secondary Outcomes

  • Patient satisfaction and barriers to participation(Week 26)
  • Change in heart rate(Baseline to Week 26)
  • Change in HbA1C(Baseline to Week 26)
  • Change in blood pressure(Baseline to Week 26)
  • Change in lipid profile(Baseline to Week 26)
  • Change in fasting blood glucose(Baseline to Week 26)

Study Sites (1)

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