Health Behavior Clinical Trial
— Life of Health| 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 |
| 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 |
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).
| 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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Brazil | University of Sao Paulo | Sao Paulo |
| Lead Sponsor | Collaborator |
|---|---|
| University of Sao Paulo |
Brazil,
| 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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