ObesityNCT02489149
Food and Nutrition Education in Quilombolas Communities With Food Insecurity: Multi-sector Intervention
A study testing Multi-sector interventions in people with Obesity, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
To optimize the food security in quilombolas communities with high prevalence of food insecurity and obesity, the present study proposes to test a multi-sector intervention including agriculture sectors, health professionals and family members of communities, based on promotion of traditional food practices, health… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Multi-sector interventions
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2015to May 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Quilombolas certified communities in Rio Grande do Sul, Brazil, with higher prevalence of food insecurity and obesity.
Who cannot join
- Community leaders with no interest in study intervention.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Pos-graduated Program in Epidemiology. Federal University of Rio Grande do Sul.
Porto Alegre, Rio Grande do Sul, 90035-003
About this study
Official title: Food and Nutrition Education in Quilombolas Communities With Food Insecurity: Intervention Based on Traditional Food Practices, Healthy Eating Promotion and Enforceability of Human Right to Adequate Food
To optimize the food security in quilombolas communities with high prevalence of food insecurity and obesity, the present study proposes to test a multi-sector intervention including agriculture sectors, health professionals and family members of communities, based on promotion of traditional food practices, health eating and enforceability of human right to adequate food.
Read the detailed description
The present study proposes to develop nutrition education strategies through multi-sector intervention in order to promote the consumption of healthy foods and improvements in the health status of the quilombola population.This is a non-randomized cluster trial in four quilombolas communities in Southern Brazil (Passo do Lorenço, Algodão, Serrinha do Cristal and Nova Palma), combining qualitative and quantitative methodologies.
- Conditions
- Obesity
- Being tested
- Multi-sector interventions, Control
- Keywords
- food insecurity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-sector interventionsOther
- Multi-sector interventions to enhance food security: Agricultural interventions are matched with field training for government sectors working with quilombolas communities on best agronomic practices to promote technical assistance for this communities. Stimulate the participation in the Program of Food Acquisition, supporting quilombolas agriculture.
- For quilombolas participants: nutritional counseling based on traditional healthy cooking practices, using traditional recipes.
- For health professionals: to strengthen food and nutrition actions at all levels of health care. Food and nutritional education training for primary care health professionals.
- Helping families to have more knowledge about your citizen rights.
ControlOther
Also called Placebo
Placebo Comparator: Conventional approach of current public food and nutrition policies.
| Study group | Role | What they receive |
|---|---|---|
| Multi-sector interventions | Experimental | Multi-sector interventions
* Multi-sector interventions to enhance food security: Agricultural interventions are matched with field training for government sectors working with quilombolas communities on best agronomic practices to promote technical assistance for this communities. Stimulate the participation in the Program of Food Acquisition, supporting quilombolas agriculture.
* For quilombolas participants: nutritional counseling based on traditional healthy cooking practices, using traditional recipes.
* For health professionals: to strengthen food and nutrition actions at all levels of health care. Food and nutritional education training for primary care health professionals.
* Helping families to have more knowledge about your citizen rights. Receives: Other: Multi-sector interventions |
| Control | Placebo comparator | Conventional approach of current public food and nutrition policies. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Brazilian Food Insecurity Scale score
Measured: 16 weeks after multisector intervention
Secondary outcomes (3)
Improve consumption of healthy foods
Healthy Eating Index (HEI) score. HEI is an indicator of dietary quality developed according to current Brazilian nutritional recommendations.
Measured: 16 weeks after multisector intervention
Number of participants who access food programs
Measured: 16 weeks after multisector intervention
Number of participants that improve knowledge about citizen rights.
Measured: 16 weeks after multisector intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
- Responsible party
- Principal investigator, Marilda Borges Neutzling, Federal University of Rio Grande do Sul
- Investigators
- Marilda Neutzling, PhD, Principal investigator, Post Graduate Studies Program in Epidemiology. Federal University of Rio Grande do SulMichele Drehmer, PhD, Study chair, Post Graduate Studies Program in Epidemiology. Federal University of Rio Grande do SulDaniela Knauth, PhD, Study chair, Post Graduate Studies Program in Epidemiology. Federal University of Rio Grande do SulFernanda Bairros, PhD, Study chair, Post Graduate Studies Program in Epidemiology. Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489149
- Sponsor's protocol ID
- 25445
- Status last verified
- Apr 2019
- First submitted
- 29 Jun 2015
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Pacheco PM, Bairros FS, Neutzling MB, Nunes LN, Knauth DR, Dos Santos FS, Drehmer M. Effectiveness of a Nutrition Counseling Intervention on Food Consumption, According to the Degree of Processing: A Community-Based Non-Randomized Trial of Quilombola Communities in South Brazil. Int J Public Health. 2024 Nov 27;69:1607549. doi: 10.3389/ijph.2024.1607549. eCollection 2024.
PubMed 39664767
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food and Nutrition Education in Quilombolas Communities With Food Insecurity: Intervention Based on Traditional Food Practices, Healthy Eating Promotion and Enforceability of Human Right to Adequate Food
- ClinicalTrials.gov ID
- NCT02489149
- Acronym / sponsor ID
- 25445
- Conditions
- Obesity
- Keywords
- food insecurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
- Study start
- Mar 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 2 Jul 2015 (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.
To optimize the food security in quilombolas communities with high prevalence of food insecurity and obesity, the present study proposes to test a multi-sector intervention including agriculture sectors, health professionals and family members of communities, based on promotion of traditional food practices, health eating and enforceability of human right to adequate food.
Detailed description
The present study proposes to develop nutrition education strategies through multi-sector intervention in order to promote the consumption of healthy foods and improvements in the health status of the quilombola population.This is a non-randomized cluster trial in four quilombolas communities in Southern Brazil (Passo do Lorenço, Algodão, Serrinha do Cristal and Nova Palma), combining qualitative and quantitative methodologies.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-sector interventions | Experimental | Other: Multi-sector interventionsMulti-sector interventions * Multi-sector interventions to enhance food security: Agricultural interventions are matched with field training for government sectors working with quilombolas communities on best agronomic practices to promote technical assistance for this communities. Stimulate the participation in the Program of Food Acquisition, supporting quilombolas agriculture. * For quilombolas participants: nutritional counseling based on traditional healthy cooking practices, using traditional recipes. * For health professionals: to strengthen food and nutrition actions at all levels of health care. Food and nutritional education training for primary care health professionals. * Helping families to have more knowledge about your citizen rights. |
| Control | Placebo comparator | Other: ControlConventional approach of current public food and nutrition policies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Quilombolas certified communities in Rio Grande do Sul, Brazil, with higher prevalence of food insecurity and obesity.
Key exclusion criteria (1 listed)
- Community leaders with no interest in study intervention.
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 |
|---|---|---|
| Multi-sector interventions* Multi-sector interventions to enhance food security: Agricultural interventions are matched with field training for government sectors working with quilombolas communities on best agronomic practices to promote technical assistance for this communities. Stimulate the participation in the Program of Food Acquisition, supporting quilombolas agriculture. * For quilombolas participants: nutritional counseling based on traditional healthy cooking practices, using traditional recipes. * For health professionals: to strengthen food and nutrition actions at all levels of health care. Food and nutritional education training for primary care health professionals. * Helping families to have more knowledge about your citizen rights. | Other | Multi-sector interventions |
| ControlAlso: PlaceboPlacebo Comparator: Conventional approach of current public food and nutrition policies. | Other | Control |
Primary outcome
Reduction in Brazilian Food Insecurity Scale score
Time frame: 16 weeks after multisector intervention
3 secondary outcomes
Improve consumption of healthy foods
Time frame: 16 weeks after multisector intervention
Number of participants who access food programs
Time frame: 16 weeks after multisector intervention
Number of participants that improve knowledge about citizen rights.
Time frame: 16 weeks after multisector intervention
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 19 Apr 2019.
- Derived from this study: PubMed 39664767Pacheco PM, Bairros FS, Neutzling MB, Nunes LN, Knauth DR, Dos Santos FS, Drehmer M. Effectiveness of a Nutrition Counseling Intervention on Food Consumption, According to the Degree of Processing: A Community-Based Non-Randomized Trial of Quilombola Communities in South Brazil. Int J Public Health. 2024 Nov 27;69:1607549. doi: 10.3389/ijph.2024.1607549. eCollection 2024.
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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.
Marilda Neutzling, PhD principal investigator
Post Graduate Studies Program in Epidemiology. Federal University of Rio Grande do Sul
Michele Drehmer, PhD study chair
Post Graduate Studies Program in Epidemiology. Federal University of Rio Grande do Sul
Daniela Knauth, PhD study chair
Post Graduate Studies Program in Epidemiology. Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-sector interventions in people with Obesity, run by Federal University of Rio Grande do Sul 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 19 Apr 2019. 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. Some participants in this study may receive a placebo. 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?
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?
Reduction in Brazilian Food Insecurity Scale score (time frame: 16 weeks after multisector intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02489149, which also lists 1 linked publication.
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 19 Apr 2019.