Sugar IntakePhase 3NCT01267474
Reducing the Use of Sugar by School Lunch Cooks in Public Schools
A Phase 3 study testing Nutritional education in people with Sugar Intake, run by Rio de Janeiro State University at 1 site in Brazil.
Trial summary
The main objective was to evaluate the effect of a nutritional education program for school lunch cooks, aiming to reduce added sugar in schools meals and in their sugar intake. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Sugar Intake
- What is being tested?
- Nutritional education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2007to Dec 2007
- Phase
- Phase 3
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who were working in the function of school lunch cook in the schools.
Who cannot join
- Pregnancy, male.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Rio de Janeiro State University
Rio de Janeiro, Rio de Janeiro, 20550-900
About this study
Official title: Reducing the Use and the Consumption of Sugar by School Lunch Cooks in Public Schools: a Cluster Randomized Trial
The main objective was to evaluate the effect of a nutritional education program for school lunch cooks, aiming to reduce added sugar in schools meals and in their sugar intake.
Read the detailed description
Although Brazil is the largest producer and one of the world's largest consumers of sugar, research on sugar consumption is still a weak point among health indicators and there are no population studies to investigate the sugar intake in Brazilian population. Available data have shown reduction in the consumption of refined sugar (-37% between 1996 and 2003) but significant increase in consumption of soft drinks (400%), which constitute the main vehicle for consumption of added sugar. Moreover, studies have shown the adverse effects of excessive consumption of added sugar in dental caries and health, as excess energy intake hence in weight gain. Although several factors are associated with weight gain in adolescents, adults and elders, and several strategies have been released by both Brazil and International Agencies, as the Global Strategy, increased weight gain, particularly in adolescents, has been observed in several countries with large increase in Brazil, justifying specific projects to evaluate which messages, strategies and proposals for intervention would be effective.
- Conditions
- Sugar Intake
- Being tested
- Nutritional education, Control
- Keywords
- School children, Sugar intake, Nutritional education program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional educationOther
Also called Use and consumption of sugar, School lunch cooks
A nutritional education program was carried out during seven months of one school year aiming to reduce added sugar in school meals by the school lunch cooks and in their own consumption.
All women in the intervention group participated in three sections about sugar consumption and one section on food labeling, as well as recipes competition of with reducing sugar.
Printed material and gifts, such as mugs, refrigerator magnets and small purses with the logo of the campaign were given to the participants.
All sections of education were delivered in the schools. The activities required 20 to 30 minutes and were facilitated by trained research assistants. Printed instructions and orientations on the facilitation process supported the assistants' efforts.
ControlOther
Also called General sessions on health issues
The control group received only three one-hour general sessions on health issues.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional education | Experimental | Not described Receives: Other: Nutritional education |
| Control | No intervention | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sugar intake
Reducing added sugar in the schools meals by school lunch cooks and in their sugar intake.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2010 (estimated)
- Study startMar 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sugar IntakeStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Investigators
- Rosely Sichieri, PhD, Principal investigator, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267474
- Sponsor's protocol ID
- CNPQ:474135/2006-3
- Status last verified
- Nov 2010
- First submitted
- 27 Dec 2010
- Last updated
- 28 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing the Use and the Consumption of Sugar by School Lunch Cooks in Public Schools: a Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT01267474
- Acronym / sponsor ID
- CNPQ:474135/2006-3
- Conditions
- Sugar Intake
- Keywords
- School children, Sugar intake, Nutritional education program
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Mar 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 28 Dec 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 main objective was to evaluate the effect of a nutritional education program for school lunch cooks, aiming to reduce added sugar in schools meals and in their sugar intake.
Detailed description
Although Brazil is the largest producer and one of the world's largest consumers of sugar, research on sugar consumption is still a weak point among health indicators and there are no population studies to investigate the sugar intake in Brazilian population. Available data have shown reduction in the consumption of refined sugar (-37% between 1996 and 2003) but significant increase in consumption of soft drinks (400%), which constitute the main vehicle for consumption of added sugar. Moreover, studies have shown the adverse effects of excessive consumption of added sugar in dental caries and health, as excess energy intake hence in weight gain. Although several factors are associated with weight gain in adolescents, adults and elders, and several strategies have been released by both Brazil and International Agencies, as the Global Strategy, increased weight gain, particularly in adolescents, has been observed in several countries with large increase in Brazil, justifying specific projects to evaluate which messages, strategies and proposals for intervention would be effective.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional education | Experimental | Other: Nutritional education |
| Control | No intervention | Other: Control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women who were working in the function of school lunch cook in the schools.
Key exclusion criteria (1 listed)
- Pregnancy, male.
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 educationAlso: Use and consumption of sugar, School lunch cooksA nutritional education program was carried out during seven months of one school year aiming to reduce added sugar in school meals by the school lunch cooks and in their own consumption. All women in the intervention group participated in three sections about sugar consumption and one section on food labeling, as well as recipes competition of with reducing sugar. Printed material and gifts, such as mugs, refrigerator magnets and small purses with the logo of the campaign were given to the participants. All sections of education were delivered in the schools. The activities required 20 to 30 minutes and were facilitated by trained research assistants. Printed instructions and orientations on the facilitation process supported the assistants' efforts. | Other | Nutritional education |
| ControlAlso: General sessions on health issuesThe control group received only three one-hour general sessions on health issues. | Other | Control |
Primary outcome
Sugar intake
Time frame: 10 months
Reducing added sugar in the schools meals by school lunch cooks and in their sugar intake.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 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.
Rosely Sichieri, PhD principal investigator
Rio de Janeiro State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nutritional education in people with Sugar Intake, run by Rio de Janeiro State University 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: finished, as of the sponsor's last update on 28 Dec 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sugar intake (time frame: 10 months). 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 28 Dec 2010.