Impact of Educational Group Intervention on the Consumption of Fruit and Vegetables

Adult Clinical Trial

— fvphc  

Official title:

Impact of Educational Group Intervention on the Consumption of Fruit and Vegetables by Adult People Attended to Primary Health Care.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01209481
• Other study ID #: upeclin/HC/FMB-Unesp-48
• 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

Related Conditions & MeSH terms

• Adult
• Inclusion Criteria:
• No Lactation
• No Morbidity
• No Pregnancy

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