- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05460897
Health Behaviour Change in Brazilians
July 12, 2022 updated by: Darren Warburton, University of British Columbia
Health Behaviour Change in Brazilians - Effectiveness of a Pan-Canadian English-language Program, Translated Into Brazilian Portuguese, to Increase Healthy Behaviours
Chronic diseases are the leading health problem in Brazil and Canada.
Such diseases share common risk factors in common, such as physical inactivity, poor diet, and smoking.
This context requires a comprehensive approach to change these behavioural risk factors, aiming at the promotion of healthy lifestyles and the prevention of diseases.
Although Brazil and Canada have significant differences, particularly in terms of socioeconomic factors, some similarities in the health domain allow both countries to mutually benefit from an exchange of knowledge.
For instance, the newest version of Canada's dietary guidelines has incorporated several aspects presented in the pioneering evidence-based dietary guidelines for the Brazilian population, launched in 2014.
Similarly, Brazil can greatly benefit if the country follows the Canadian lead in prioritizing investment in physical activity initiatives.
The present project aims to verify the effectiveness of a Canadian program to change health behaviours, specifically physical inactivity, poor diet, and smoking, adapted for Brazilians.
The project consists of a 12-week randomized controlled trial, based on education and behaviour change techniques focusing on physical activity, healthy eating habits, and smoking cessation.
Pre-, post, and 3-month follow-up health and fitness assessments will evaluate respectively the initial condition of the participants, eventual changes and if the changes persist.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
124
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Darren Warburton, PhD
- Phone Number: 604-822-4603
- Email: darren.warburton@ubc.ca
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6T1Z4
- University of British Columbia
-
Contact:
- Juliano Schwartz, PhD
- Phone Number: 604-822-1337
- Email: juliano@alumni.ubc.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Brazilians who speak Brazilian Portuguese fluently, and present at least one of the following risk factors:
- physical inactivity (<150 min of MVPA per week)
- unhealthy diet (consumption of fewer than five fruits/vegetables per day)
- smoking (any amount of personal tobacco use)
Exclusion Criteria:
- unstable clinical conditions
- inability to participate fully in the program due to mental or physical limitations
- concurrently participation in other studies of intensive health behaviour modification
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
12-week intervention consisting of educational sessions and health behaviour change techniques
|
weekly sessions addressing strategies to tackle behavioural risk factors for chronic disease
|
|
No Intervention: Waitlist control group
After the first 12 weeks, this group will receive the same intervention as the experimental group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity
Time Frame: 12 weeks
|
change in the proportion of participants engaging in ≥ 150 min moderate to vigorous physical activity (MVPA) per week
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Darren Warburton, PhD, Professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2022
Primary Completion (Anticipated)
July 1, 2023
Study Completion (Anticipated)
July 1, 2024
Study Registration Dates
First Submitted
July 12, 2022
First Submitted That Met QC Criteria
July 12, 2022
First Posted (Actual)
July 15, 2022
Study Record Updates
Last Update Posted (Actual)
July 15, 2022
Last Update Submitted That Met QC Criteria
July 12, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- H17-03564
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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