Remote vs In Person Weight Loss Study

NCT ID: NCT04658550

Last Updated: 2023-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-16

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Remote Weight Loss Behaviour Modification Program with Meal Replacements

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.

Remote Behaviour Modification Program

Intervention Type OTHER

The standard of care behaviour modification program for weight loss will be offered virtually due to the COVID-19 pandemic (prospective).

In Person Weight Bahaviour Modification Program with Meal Replacements

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.

In Person Behaviour Modification Program

Intervention Type OTHER

The standard of care behaviour modification program for weight loss was offered in person prior to the COVID-19 pandemic (retrospective).

Interventions

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Remote Behaviour Modification Program

The standard of care behaviour modification program for weight loss will be offered virtually due to the COVID-19 pandemic (prospective).

Intervention Type OTHER

In Person Behaviour Modification Program

The standard of care behaviour modification program for weight loss was offered in person prior to the COVID-19 pandemic (retrospective).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role lead

Responsible Party

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Tony Chetty

Associate Professor Pathology and Molecular Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tony Chetty, MD

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Healthcare Hamilton

Locations

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St Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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Remote v In Person Weight Loss

Identifier Type: -

Identifier Source: org_study_id

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