Physical InactivityNCT05460897
Health Behaviour Change in Brazilians
A study testing Health behaviour change in people with Physical Inactivity and Eating Behavior, run by University of British Columbia at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Eating Behavior, Smoking
- What is being tested?
- Health behaviour change
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2022to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6T1Z4
Juliano Schwartz, PhD, 604-822-1337, juliano@alumni.ubc.ca
About this study
Official title: 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.
- Conditions
- Physical Inactivity, Eating Behavior, Smoking
- Being tested
- Health behaviour change
- Medical subject headings
- Sedentary Behavior, Feeding Behavior, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health behaviour changeBehavioural
weekly sessions addressing strategies to tackle behavioural risk factors for chronic disease
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 12-week intervention consisting of educational sessions and health behaviour change techniques Receives: Behavioral: Health behaviour change |
| Waitlist control group | No intervention | After the first 12 weeks, this group will receive the same intervention as the experimental group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
change in the proportion of participants engaging in ≥ 150 min moderate to vigorous physical activity (MVPA) per week
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study startJul 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Darren Warburton, University of British Columbia
- Investigators
- Darren Warburton, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460897
- Sponsor's protocol ID
- H17-03564
- Status last verified
- Jul 2022
- First submitted
- 12 Jul 2022
- Last updated
- 15 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Behaviour Change in Brazilians - Effectiveness of a Pan-Canadian English-language Program, Translated Into Brazilian Portuguese, to Increase Healthy Behaviours
- ClinicalTrials.gov ID
- NCT05460897
- Acronym / sponsor ID
- H17-03564
- Conditions
- Physical Inactivity, Eating Behavior, Smoking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Health behaviour change12-week intervention consisting of educational sessions and health behaviour change techniques |
| Waitlist control group | No intervention | –After the first 12 weeks, this group will receive the same intervention as the experimental group |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health behaviour changeweekly sessions addressing strategies to tackle behavioural risk factors for chronic disease | Behavioural | Experimental |
Primary outcome
Physical activity
Time frame: 12 weeks
change in the proportion of participants engaging in ≥ 150 min moderate to vigorous physical activity (MVPA) per week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
Related trials for Physical Inactivity
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruiting
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
Depression, Physical Inactivity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren Warburton, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health behaviour change in people with Physical Inactivity and Eating Behavior, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Darren Warburton, PhD (604-822-4603, darren.warburton@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.