Impact of Educational Group Intervention on the Consumption of Fruit and Vegetables
fvphc
1 other identifier
interventional
80
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2010
1 active site
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
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedFirst Posted
Study publicly available on registry
September 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedSeptember 27, 2010
September 1, 2010
4 months
August 30, 2010
September 24, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
consumption of fruit and vegetables
Jan 2011
Study Arms (2)
Nutritional education
EXPERIMENTALcontrol
NO INTERVENTIONInterventions
The educational group activities will consist of two-hour group dynamics and cooking workshops once a week and for five weeks.
Eligibility Criteria
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
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Antonieta BL Carvalhaes, PHD
Sao Paulo State University, Faculty of Medicine
Central Study Contacts
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