Primary PreventionFLAMNCT02461238
Impact of Vouchers and Nutrition Education on the Consumption of Fruits and Vegetables Among Vulnerable Families (FLAM)
A study testing Vouchers and Nutrition education in people with Primary Prevention and Nutrition Policy, run by University of Paris 13 at 1 site in France.
Trial summary
The purpose of this study is to assess whether fruit and vegetables vouchers combined with educational support may increase fruits and vegetables consumption of children aged 3 to 10 living in vulnerable families in Saint-Denis, France. Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Prevention, Nutrition Policy
- What is being tested?
- Vouchers and Nutrition education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Jul 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 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- At least one of the following criteria :
- One or both parent(s) is/are beneficiary of resource allocation condition
- One or both parent is/are unemployed
- Household income below the poverty line
- Minimum of one child aged 3 to 10 at the time of the inclusion
- Stable housing
Who cannot join
- Parent is under 18
- Family having no permanent address or planned move within a year
- Consent form unsigned
- Opposition of a parent for their child's inclusion in the study
- Higher household income of 1700 euros per month for single-parent family or higher than 2 000 euros for other families
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etude Fruits et Légumes à la Maison (FLAM)
The purpose of this study is to assess whether fruit and vegetables vouchers combined with educational support may increase fruits and vegetables consumption of children aged 3 to 10 living in vulnerable families in Saint-Denis, France.
- Conditions
- Primary Prevention, Nutrition Policy
- Being tested
- Vouchers, Nutrition education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VouchersOther
The vouchers sent to families can be used in supermarkets for fresh, frozen or canned fruits and vegetables, excluding potatoes. The amount of the vouchers takes into account family composition, calculated to correspond to a serving per day per person.
Nutrition educationOther
Nutrition education workshops taught by a dietician
| Study group | Role | What they receive |
|---|---|---|
| Vouchers | Active comparator | Families included in the Voucher arm will receive vouchers for fruits and vegetables by mail every month for a period of 1 year coupled to nutritional education from a dietician Receives: Other: Vouchers; Other: Nutrition education |
| Control | Other | Families included in the control arm will only receive nutritional education Receives: Other: Nutrition education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of small consumers of fruits and vegetables among children
Average daily intake of fruits and vegetables is measured using a food frequency questionnaire, in order to determine the proportion of small consumer of fruits and vegetables. Before-after comparisons will be made in each arm, and compared between both arms at T+1.
Subjects consuming less than 3.5 servings of fruit and vegetables per day are defined as small consumers.
Measured: 12 months
Secondary outcomes (2)
Proportion of small consumers of fruits and vegetables among adults (parents)
Average daily intake of fruits and vegetables is measured using a food frequency questionnaire, in order to determine the proportion of small consumer of fruits and vegetables. Before-after comparisons will be made in each arm, and compared between both arms at T+1.
Subjects consuming less than 3.5 servings of fruit and vegetables per day are defined as small consumers.
Measured: 12 months
Utilization rate of vouchers (voucher arm)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary PreventionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Paris 13
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de la Santé, France, Maison de la Santé de la ville de Saint Denis, Ville de Saint Denis, Programme Malin, Institut national de prevention et d'education pour la sante
- Responsible party
- Principal investigator, Serge HERCBERG, University of Paris 13
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461238
- Sponsor's protocol ID
- UParis13
- Acronym
- FLAM
- Status last verified
- Sep 2017
- First submitted
- 27 May 2015
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Buscail C, Gendreau J, Daval P, Lombrail P, Hercberg S, Latino-Martel P, Julia C. Impact of fruits and vegetables vouchers on food insecurity in disadvantaged families from a Paris suburb. BMC Nutr. 2019 Apr 4;5:26. doi: 10.1186/s40795-019-0289-4. eCollection 2019.
PubMed 32153939Buscail C, Margat A, Miszkowicz T, Gendreau J, Daval P, Lombrail P, Hercberg S, Latino-Martel P, Maurice A, Julia C. Recruitment of precarious families in an interventional study: Lessons from the French "Fruits and vegetables at home" (FLAM) trial. Contemp Clin Trials Commun. 2018 Nov 2;12:161-168. doi: 10.1016/j.conctc.2018.10.008. eCollection 2018 Dec.
PubMed 30480163Buscail C, Margat A, Petit S, Gendreau J, Daval P, Lombrail P, Hercberg S, Latino-Martel P, Maurice A, Julia C. Fruits and vegetables at home (FLAM): a randomized controlled trial of the impact of fruits and vegetables vouchers in children from low-income families in an urban district of France. BMC Public Health. 2018 Aug 28;18(1):1065. doi: 10.1186/s12889-018-5908-5.
PubMed 30153820
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude Fruits et Légumes à la Maison (FLAM)
- ClinicalTrials.gov ID
- NCT02461238
- Acronym / sponsor ID
- FLAM / UParis13
- Conditions
- Primary Prevention, Nutrition Policy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of Paris 13University, hospital or other
- Collaborators
- Direction Générale de la Santé, France, Maison de la Santé de la ville de Saint Denis, Ville de Saint Denis, Programme Malin, Institut national de prevention et d'education pour la sante
- Study start
- Jun 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 3 Jun 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.
The purpose of this study is to assess whether fruit and vegetables vouchers combined with educational support may increase fruits and vegetables consumption of children aged 3 to 10 living in vulnerable families in Saint-Denis, France.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vouchers | Active comparator | Other: Vouchers, Other: Nutrition educationFamilies included in the Voucher arm will receive vouchers for fruits and vegetables by mail every month for a period of 1 year coupled to nutritional education from a dietician |
| Control | Other | Other: Nutrition educationFamilies included in the control arm will only receive nutritional education |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- At least one of the following criteria :
- Minimum of one child aged 3 to 10 at the time of the inclusion
- Stable housing
Key exclusion criteria (5 listed)
- Parent is under 18
- Family having no permanent address or planned move within a year
- Consent form unsigned
- Opposition of a parent for their child's inclusion in the study
- Higher household income of 1700 euros per month for single-parent family or higher than 2 000 euros for other families
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 |
|---|---|---|
| VouchersThe vouchers sent to families can be used in supermarkets for fresh, frozen or canned fruits and vegetables, excluding potatoes. The amount of the vouchers takes into account family composition, calculated to correspond to a serving per day per person. | Other | Vouchers |
| Nutrition educationNutrition education workshops taught by a dietician | Other | Control, Vouchers |
Primary outcome
Proportion of small consumers of fruits and vegetables among children
Time frame: 12 months
Average daily intake of fruits and vegetables is measured using a food frequency questionnaire, in order to determine the proportion of small consumer of fruits and vegetables. Before-after comparisons will be made in each arm, and compared between both arms at T+1. Subjects consuming less than 3.5 servings of fruit and vegetables per day are defined as small consumers.
2 secondary outcomes
Proportion of small consumers of fruits and vegetables among adults (parents)
Time frame: 12 months
Utilization rate of vouchers (voucher arm)
Time frame: 12 months
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 3 Oct 2017.
- Derived from this study: PubMed 32153939Buscail C, Gendreau J, Daval P, Lombrail P, Hercberg S, Latino-Martel P, Julia C. Impact of fruits and vegetables vouchers on food insecurity in disadvantaged families from a Paris suburb. BMC Nutr. 2019 Apr 4;5:26. doi: 10.1186/s40795-019-0289-4. eCollection 2019.
- Derived from this study: PubMed 30480163Buscail C, Margat A, Miszkowicz T, Gendreau J, Daval P, Lombrail P, Hercberg S, Latino-Martel P, Maurice A, Julia C. Recruitment of precarious families in an interventional study: Lessons from the French "Fruits and vegetables at home" (FLAM) trial. Contemp Clin Trials Commun. 2018 Nov 2;12:161-168. doi: 10.1016/j.conctc.2018.10.008. eCollection 2018 Dec.
- Derived from this study: PubMed 30153820Buscail C, Margat A, Petit S, Gendreau J, Daval P, Lombrail P, Hercberg S, Latino-Martel P, Maurice A, Julia C. Fruits and vegetables at home (FLAM): a randomized controlled trial of the impact of fruits and vegetables vouchers in children from low-income families in an urban district of France. BMC Public Health. 2018 Aug 28;18(1):1065. doi: 10.1186/s12889-018-5908-5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vouchers and Nutrition education in people with Primary Prevention and Nutrition Policy, run by University of Paris 13 at 1 site in France.
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 6 inclusion and 5 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 3 Oct 2017. 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 France. 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?
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?
Proportion of small consumers of fruits and vegetables among children (time frame: 12 months). 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 NCT02461238, which also lists 3 linked publications.
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 3 Oct 2017.