Health BehaviorLife of HealthNCT02765321
Populational Program of Physical Activity and Healthy Eating Promotion: the "Life of Health" Study
A study testing Healthy lifestyle promotion in people with Health Behavior, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This is a population-based "natural experiment" study aimed to examine the effect of a multi-approach intervention focused on physical activity and healthy eating promotion to individuals living in Jaguariuna city (São Paulo, Brazil). Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Healthy lifestyle promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2016to Dec 2016
- 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 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- citizens from Jaguariuna city (Sao Paulo, Brazil)
Who cannot join
- citizens not from Jaguariuna city (Sao Paulo, Brazil)
- children below 8 years of age.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo
São Paulo, São Paulo, 05508-30
Bruno Gualano, PhD, gualano@usp.br
Bruno Gualano, PhD
About this study
This is a population-based "natural experiment" study aimed to examine the effect of a multi-approach intervention focused on physical activity and healthy eating promotion to individuals living in Jaguariuna city (São Paulo, Brazil).
- Conditions
- Health Behavior
- Being tested
- Healthy lifestyle promotion
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy lifestyle promotionBehavioural
Healthy lifestyle changes (i.e., increase in physical activity levels and improvement in eating habits) will be promoted via population-based counselling through media (i.e., radio, newspapers, magazines, television, banners), cell phone applicative, workshops, specific programs at schools and companies, and community physical activity programs.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity and healthy eating promotion | Experimental | Not described Receives: Behavioral: Healthy lifestyle promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
waist circumference
Measured: 7 months
Secondary outcomes (15)
fasting glycemia
Measured: 7 months
fasting insulinemia
Measured: 7 months
total cholesterol
Measured: 7 months
LDL-cholesterol
Measured: 7 months
HDL-cholesterol
Measured: 7 months
triglycerides
Measured: 7 months
VLDL-cholesterol
Measured: 7 months
C-reactive protein
Measured: 7 months
objectively measured physical activity levels
assessed by accelerometers in a sub-sample
Measured: 7 months
subjectively measured physical activity levels
assessed by International Physical Activity Questionnaires (IPAQ)
Measured: 7 months
subjectively measured physical activity levels
assessed by phone interview
Measured: 7 months
food intake
food frequency questionnaire
Measured: 7 months
blood pressure
Measured: 7 months
body mass index
Measured: 7 months
self-perceived health status
assessed by phone interview
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
- Investigators
- Fabiana B Benatti, PhD, Principal investigator, University of Sao PauloMarcio Atalla, Principal investigator, Casa do BemStar Marcio AtallaEvelyn F Costa, PhD, Principal investigator, University of Sao PauloAlex Florindo, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765321
- Sponsor's protocol ID
- Life of Health Study
- Acronym
- Life of Health
- Status last verified
- May 2016
- First submitted
- 2 May 2016
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Populational Program of Physical Activity and Healthy Eating Promotion: the "Life of Health" Study
- ClinicalTrials.gov ID
- NCT02765321
- Acronym / sponsor ID
- Life of Health / Life of Health Study
- Conditions
- Health Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2016 (estimated)
- First posted
- 6 May 2016 (estimated)
- 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.
This is a population-based "natural experiment" study aimed to examine the effect of a multi-approach intervention focused on physical activity and healthy eating promotion to individuals living in Jaguariuna city (São Paulo, Brazil).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical activity and healthy eating promotion | Experimental | Behavioral: Healthy lifestyle promotion |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- citizens from Jaguariuna city (Sao Paulo, Brazil)
Key exclusion criteria (2 listed)
- citizens not from Jaguariuna city (Sao Paulo, Brazil)
- children below 8 years of age.
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 |
|---|---|---|
| Healthy lifestyle promotionHealthy lifestyle changes (i.e., increase in physical activity levels and improvement in eating habits) will be promoted via population-based counselling through media (i.e., radio, newspapers, magazines, television, banners), cell phone applicative, workshops, specific programs at schools and companies, and community physical activity programs. | Behavioural | Physical activity and healthy eating promotion |
Primary outcome
waist circumference
Time frame: 7 months
15 secondary outcomes
fasting glycemia
Time frame: 7 months
fasting insulinemia
Time frame: 7 months
total cholesterol
Time frame: 7 months
LDL-cholesterol
Time frame: 7 months
HDL-cholesterol
Time frame: 7 months
triglycerides
Time frame: 7 months
VLDL-cholesterol
Time frame: 7 months
C-reactive protein
Time frame: 7 months
objectively measured physical activity levels
Time frame: 7 months
subjectively measured physical activity levels
Time frame: 7 months
subjectively measured physical activity levels
Time frame: 7 months
food intake
Time frame: 7 months
blood pressure
Time frame: 7 months
body mass index
Time frame: 7 months
self-perceived health status
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
- Individual participant dataSharing planned: No
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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.
Fabiana B Benatti, PhD principal investigator
University of Sao Paulo
Marcio Atalla principal investigator
Casa do BemStar Marcio Atalla
Evelyn F Costa, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy lifestyle promotion in people with Health Behavior, run by University of Sao Paulo at 1 site in Brazil.
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 1 inclusion and 2 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 6 May 2016. 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 Brazil. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
waist circumference (time frame: 7 months). 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 6 May 2016.