Impact of Educational Group Intervention on the Consumption of Fruit and Vegetables (fvphc)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by UPECLIN HC FM Botucatu Unesp.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT01209481
First received: August 30, 2010
Last updated: September 24, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Inclusion Criteria:
Adult
No Pregnancy
No Lactation
No Morbidity
Behavioral: nutritional education group action

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Impact of Educational Group Intervention on the Consumption of Fruit and Vegetables by Adult People Attended to Primary Health Care.

Further study details as provided by UPECLIN HC FM Botucatu Unesp:

Primary Outcome Measures:
  • consumption of fruit and vegetables [ Time Frame: Jan 2011 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nutritional education 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.
No Intervention: control

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adult healthy

Exclusion Criteria:

  • pregnancy, lactation, morbidity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209481

Contacts
Contact: Aline GS Pereira, Ms 55-14-38141430 aline_grazi@yahoo.com.br

Locations
Brazil
Sao Paulo State University, Faculty of Medicine Not yet recruiting
Botucatu, São Paulo, Brazil
Contact: Maria Antonieta BL Carvalhaes, PHD    55-14-38135264    carvalha@fmb.unesp.br   
Principal Investigator: Maria Antonieta BL Carvalhaes, PHD         
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Investigators
Principal Investigator: Maria Antonieta BL Carvalhaes, PHD Sao Paulo State University, Faculty of Medicine
  More Information

No publications provided

Responsible Party: Maria Antonieta de Barros Leite Carvalhaes, São Paulo State University - Faculty of Medicine
ClinicalTrials.gov Identifier: NCT01209481     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-48
Study First Received: August 30, 2010
Last Updated: September 24, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by UPECLIN HC FM Botucatu Unesp:
fruits
vegetables
primary health care
nutritional education

ClinicalTrials.gov processed this record on August 19, 2014