Impact of Vouchers and Nutrition Education on the Consumption of Fruits and Vegetables Among Vulnerable Families (FLAM)

NCT ID: NCT02461238

Last Updated: 2017-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Prevention Nutrition Policy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Vouchers

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

Group Type ACTIVE_COMPARATOR

Vouchers

Intervention Type OTHER

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 education

Intervention Type OTHER

Nutrition education workshops taught by a dietician

Control

Families included in the control arm will only receive nutritional education

Group Type OTHER

Nutrition education

Intervention Type OTHER

Nutrition education workshops taught by a dietician

Interventions

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Vouchers

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.

Intervention Type OTHER

Nutrition education

Nutrition education workshops taught by a dietician

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Direction Générale de la Santé, France

OTHER

Sponsor Role collaborator

Maison de la Santé de la ville de Saint Denis

UNKNOWN

Sponsor Role collaborator

Ville de Saint Denis

UNKNOWN

Sponsor Role collaborator

Programme Malin

UNKNOWN

Sponsor Role collaborator

Institut National de Prévention et d'Education pour la Sante

UNKNOWN

Sponsor Role collaborator

University of Paris 13

OTHER

Sponsor Role lead

Responsible Party

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Serge HERCBERG

Head of department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Maison de la Santé

Saint-Denis, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 32153939 (View on PubMed)

Buscail 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.

Reference Type DERIVED
PMID: 30480163 (View on PubMed)

Buscail 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.

Reference Type DERIVED
PMID: 30153820 (View on PubMed)

Other Identifiers

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UParis13

Identifier Type: -

Identifier Source: org_study_id