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Remote vs In Person Weight Loss Study

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04658550
Enrollment
77
Registered
2020-12-08
Start date
2020-10-16
Completion date
2021-12-31
Last updated
2023-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

OTHERRemote Behaviour Modification Program

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

OTHERIn 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).

Sponsors

St. Joseph's Healthcare Hamilton
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Mean Percentage Change in Body WeightBaseline to Week 26To 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

MeasureTime frameDescription
Change in blood pressureBaseline to Week 26Change in blood pressure
Change in lipid profileBaseline to Week 26Change in lipid profile including total cholesterol, triglycerides, low density lipoprotein and high density lipoprotein
Patient satisfaction and barriers to participationWeek 26Patient 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.
Change in heart rateBaseline to Week 26Change in heart rate
Change in HbA1CBaseline to Week 26Change in HbA1C
Change in fasting blood glucoseBaseline to Week 26Change in fasting blood glucose

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026