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OpenTrials
Completed

NCT Number: NCT04658550

Remote vs In Person Weight Loss Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Joseph's Healthcare Hamilton

Hamilton, Ontario, L9C0E3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote Behaviour Modification Program

Other

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

In Person Behaviour Modification Program

Other

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

Primary outcomes

  1. 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

  1. Patient satisfaction and barriers to participation

    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.

  2. Change in blood pressure

    Time frame: Baseline to Week 26

    Change in blood pressure

  3. Change in lipid profile

    Time frame: Baseline to Week 26

    Change in lipid profile including total cholesterol, triglycerides, low density lipoprotein and high density lipoprotein

  4. Change in fasting blood glucose

    Time frame: Baseline to Week 26

    Change in fasting blood glucose

  5. Change in heart rate

    Time frame: Baseline to Week 26

    Change in heart rate

  6. Change in HbA1C

    Time frame: Baseline to Week 26

    Change in HbA1C

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 8, 2020
Registry last updated
Aug 3, 2023

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.

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