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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01209481
Other study ID # upeclin/HC/FMB-Unesp-48
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 30, 2010
Last updated September 24, 2010
Start date September 2010
Est. completion date March 2012

Study information

Verified date September 2010
Source UPECLIN HC FM Botucatu Unesp
Contact Aline GS Pereira, Ms
Phone 55-14-38141430
Email aline_grazi@yahoo.com.br
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

The right to food and nutrition is established in the Universal Declaration of Human Rights as they are basic requirements for promoting and protecting good health. They can also be instruments to evaluate the quality of life of human beings and communities. Awareness of a healthy diet is the first step in behavioral change, and nutritional education can be an instrument for avoiding diseases resulting from both intake deficit and excess. Educational group actions can change food intake. This study will aim at evaluating, planning and implementing the impact of a nutritional education group action concerning the consumption of fruit and vegetables in adult and elderly individuals attended to by a Primary Health Care (PHCU) Unit. It will be a randomized assay involving two groups comprising male and females individuals distributed in the following fashion: Intervention Group, in which the educational group action (EGA) will be performed in addition to routine activities; and Control Group, the individuals from which will only participate in the routine activities in the PHCA (Teaching Health Care Unit). The total sample will comprise 80 individuals with 40 in each group. In order to determine the consumption of fruit and vegetables, a weekday and a Sunday 24-hour recalls will be performed 2 (short-term effects) and 6 (medium-term effects) months after completing the intervention. The educational group activities will consist of two-hour group dynamics and cooking workshops once a week and for five weeks. Serum carotenoid dosages will also be performed in the two groups by sub-sampling (n=40) with the purpose to validate the estimated intake of fruit and vegetables obtained from the recalls.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date March 2012
Est. primary completion date January 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 59 Years
Eligibility Inclusion Criteria:

- adult healthy

Exclusion Criteria:

- pregnancy, lactation, morbidity

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Intervention

Behavioral:
nutritional education group action
The educational group activities will consist of two-hour group dynamics and cooking workshops once a week and for five weeks.

Locations

Country Name City State
Brazil Sao Paulo State University, Faculty of Medicine Botucatu São Paulo

Sponsors (1)

Lead Sponsor Collaborator
UPECLIN HC FM Botucatu Unesp

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary consumption of fruit and vegetables Jan 2011 No
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