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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02765321
Other study ID # Life of Health Study
Secondary ID
Status Recruiting
Phase N/A
First received May 2, 2016
Last updated May 5, 2016
Start date April 2016

Study information

Verified date May 2016
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 8 Years and older
Eligibility Inclusion Criteria:

- citizens from Jaguariuna city (Sao Paulo, Brazil)

Exclusion Criteria:

- citizens not from Jaguariuna city (Sao Paulo, Brazil)

- children below 8 years of age.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Healthy lifestyle promotion
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.

Locations

Country Name City State
Brazil University of Sao Paulo Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary waist circumference 7 months No
Secondary fasting glycemia 7 months No
Secondary fasting insulinemia 7 months No
Secondary total cholesterol 7 months No
Secondary LDL-cholesterol 7 months No
Secondary HDL-cholesterol 7 months No
Secondary triglycerides 7 months No
Secondary VLDL-cholesterol 7 months No
Secondary C-reactive protein 7 months No
Secondary objectively measured physical activity levels assessed by accelerometers in a sub-sample 7 months No
Secondary subjectively measured physical activity levels assessed by International Physical Activity Questionnaires (IPAQ) 7 months No
Secondary subjectively measured physical activity levels assessed by phone interview 7 months No
Secondary food intake food frequency questionnaire 7 months No
Secondary blood pressure 7 months No
Secondary body mass index 7 months No
Secondary self-perceived health status assessed by phone interview 7 months No
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