Remote vs In Person Weight Loss Study

NCT04658550 | Completed

• 1 other identifier: Remote v In Person Weight Loss
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Mean Percentage Change in Body Weight

  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

  Baseline to Week 26

Secondary Outcomes (6)

• Patient satisfaction and barriers to participation

  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

• Change in heart rate

  Baseline to Week 26

Study Arms (2)

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

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

Interventions

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).

Remote Weight Loss Behaviour Modification Program with Meal Replacements

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).

In Person Weight Bahaviour Modification Program with Meal Replacements

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese patients with Body Mass Index \> 35 Kg/m2 and enrolled in the behaviour modification program for weight loss at the Bariatric Centre of Excellence at St Joseph's Healthcare Hamilton

You may qualify if:

• ≥ 18 years of age
• Enrolled in 26-week BCoE behaviour modification program with meal replacements
• Able and willing to provide signed informed consent

You may not qualify if:

• \- Subjects will be excluded if they contact clinic or study personnel to withdraw consent or withdraw data from the study.

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

St Joseph's Healthcare Hamilton

Hamilton, Ontario, L9C0E3, Canada

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tony Chetty, MD

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Pathology and Molecular Medicine

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: December 8, 2020
• Study Start: October 16, 2020
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)