NCT01209481

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2010

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
26 days until next milestone

First Posted

Study publicly available on registry

September 27, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

September 27, 2010

Status Verified

September 1, 2010

Enrollment Period

4 months

First QC Date

August 30, 2010

Last Update Submit

September 24, 2010

Conditions

Keywords

fruitsvegetablesprimary health carenutritional education

Outcome Measures

Primary Outcomes (1)

  • consumption of fruit and vegetables

    Jan 2011

Study Arms (2)

Nutritional education

EXPERIMENTAL
Behavioral: nutritional education group action

control

NO INTERVENTION

Interventions

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

Nutritional education

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • adult healthy

You may not qualify if:

  • pregnancy, lactation, morbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sao Paulo State University, Faculty of Medicine

Botucatu, São Paulo, Brazil

Location

Study Officials

  • Maria Antonieta BL Carvalhaes, PHD

    Sao Paulo State University, Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aline GS Pereira, Ms

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2010

First Posted

September 27, 2010

Study Start

September 1, 2010

Primary Completion

January 1, 2011

Study Completion

March 1, 2012

Last Updated

September 27, 2010

Record last verified: 2010-09

Locations