Remote vs In Person Weight Loss Study

Sponsor
St. Joseph's Healthcare Hamilton (Other)
Overall Status
Recruiting
CT.gov ID
NCT04658550
Collaborator
(none)
120
1
11.5
10.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Remote Behaviour Modification Program
  • Other: In Person Behaviour Modification Program

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Other
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.
Actual Study Start Date :
Oct 16, 2020
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Oct 1, 2021

Arms and Interventions

Arm Intervention/Treatment
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.

Other: 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).

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.

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).

Outcome Measures

Primary Outcome Measures

  1. Mean Percentage Change in Body Weight [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 Outcome Measures

  1. Patient satisfaction and barriers to participation [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 [Baseline to Week 26]

    Change in blood pressure

  3. Change in lipid profile [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 [Baseline to Week 26]

    Change in fasting blood glucose

  5. Change in heart rate [Baseline to Week 26]

    Change in heart rate

  6. Change in HbA1C [Baseline to Week 26]

    Change in HbA1C

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 St Joseph's Healthcare Hamilton Hamilton Ontario Canada L9C0E3

Sponsors and Collaborators

  • St. Joseph's Healthcare Hamilton

Investigators

  • Principal Investigator: Tony Chetty, MD, St. Joseph's Healthcare Hamilton

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tony Chetty, Associate Professor Pathology and Molecular Medicine, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT04658550
Other Study ID Numbers:
  • Remote v In Person Weight Loss
First Posted:
Dec 8, 2020
Last Update Posted:
Dec 8, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 8, 2020