Populational Program of Physical Activity and Healthy Eating Promotion: the "Life of Health" Study (Life of Health)

May 5, 2016 updated by: Bruno Gualano, University of Sao Paulo
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10000

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 Locations

  • Brazil
      • Sao Paulo, Brazil, 05508-30
        • Recruiting
        • University of Sao Paulo
        • Contact:

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

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical activity and healthy eating promotion
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
waist circumference
Time Frame: 7 months
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fasting glycemia
Time Frame: 7 months
7 months
fasting insulinemia
Time Frame: 7 months
7 months
total cholesterol
Time Frame: 7 months
7 months
LDL-cholesterol
Time Frame: 7 months
7 months
HDL-cholesterol
Time Frame: 7 months
7 months
triglycerides
Time Frame: 7 months
7 months
VLDL-cholesterol
Time Frame: 7 months
7 months
C-reactive protein
Time Frame: 7 months
7 months
objectively measured physical activity levels
Time Frame: 7 months
assessed by accelerometers in a sub-sample
7 months
subjectively measured physical activity levels
Time Frame: 7 months
assessed by International Physical Activity Questionnaires (IPAQ)
7 months
subjectively measured physical activity levels
Time Frame: 7 months
assessed by phone interview
7 months
food intake
Time Frame: 7 months
food frequency questionnaire
7 months
blood pressure
Time Frame: 7 months
7 months
body mass index
Time Frame: 7 months
7 months
self-perceived health status
Time Frame: 7 months
assessed by phone interview
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Fabiana B Benatti, PhD, University of Sao Paulo
  • Principal Investigator: Marcio Atalla, Casa do BemStar Marcio Atalla
  • Principal Investigator: Evelyn F Costa, PhD, University of Sao Paulo
  • Principal Investigator: Alex Florindo, PhD, University of Sao Paulo

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

April 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

May 2, 2016

First Submitted That Met QC Criteria

May 5, 2016

First Posted (Estimate)

May 6, 2016

Study Record Updates

Last Update Posted (Estimate)

May 6, 2016

Last Update Submitted That Met QC Criteria

May 5, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • Life of Health Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Clinical Trials on Health Behavior

Clinical Trials on Healthy lifestyle promotion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe