Inclusion Criteria:fvphcNCT01209481
Impact of Educational Group Intervention on the Consumption of Fruit and Vegetables
A study testing nutritional education group action in people with Inclusion Criteria: and Adult, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Inclusion Criteria:, Adult, No Pregnancy
- What is being tested?
- nutritional education group action
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2010to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- adult healthy
Who cannot join
- pregnancy, lactation, morbidity
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Sao Paulo State University, Faculty of Medicine
Botucatu, São Paulo
Maria Antonieta BL Carvalhaes, PHD, 55-14-38135264, carvalha@fmb.unesp.br
Maria Antonieta BL Carvalhaes, PHD
About this study
Official title: Impact of Educational Group Intervention on the Consumption of Fruit and Vegetables by Adult People Attended to Primary Health Care.
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.
- Conditions
- Inclusion Criteria:, Adult, No Pregnancy, No Lactation, No Morbidity
- Being tested
- nutritional education group action
- Keywords
- fruits, vegetables, primary health care, nutritional education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional education group actionBehavioural
The educational group activities will consist of two-hour group dynamics and cooking workshops once a week and for five weeks.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional education | Experimental | Not described Receives: Behavioral: nutritional education group action |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
consumption of fruit and vegetables
Measured: Jan 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2011 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inclusion Criteria:Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Investigators
- Maria Antonieta BL Carvalhaes, PHD, Principal investigator, Sao Paulo State University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209481
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-48
- Acronym
- fvphc
- Status last verified
- Sep 2010
- First submitted
- 30 Aug 2010
- Last updated
- 27 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Educational Group Intervention on the Consumption of Fruit and Vegetables by Adult People Attended to Primary Health Care.
- ClinicalTrials.gov ID
- NCT01209481
- Acronym / sponsor ID
- fvphc / upeclin/HC/FMB-Unesp-48
- Conditions
- Inclusion Criteria:, Adult, No Pregnancy, No Lactation, No Morbidity
- Keywords
- fruits, vegetables, primary health care, nutritional education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 27 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional education | Experimental | Behavioral: nutritional education group action |
| control | No intervention | – |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- adult healthy
Key exclusion criteria (1 listed)
- pregnancy, lactation, morbidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutritional education group actionThe educational group activities will consist of two-hour group dynamics and cooking workshops once a week and for five weeks. | Behavioural | Nutritional education |
Primary outcome
consumption of fruit and vegetables
Time frame: Jan 2011
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Antonieta BL Carvalhaes, PHD principal investigator
Sao Paulo State University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutritional education group action in people with Inclusion Criteria: and Adult, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aline GS Pereira, Ms (55-14-38141430, aline_grazi@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
consumption of fruit and vegetables (time frame: Jan 2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2010.