Clinical trial NCT02461238: Impact of Vouchers and Nutrition Education on the Consumption of Fruits and Vegetables Among Vulnerable Families (FLAM)
Official title: Etude Fruits et Légumes à la Maison (FLAM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Prevention
Nutrition Policy
Lead sponsor: University of Paris 13
Sponsor class: OTHER
Collaborators: name: Direction Générale de la Santé, France
name: Maison de la Santé de la ville de Saint Denis
name: Ville de Saint Denis
name: Programme Malin
name: Institut National de Prévention et d'Education pour la Sante
First posted: 2015-06-03
Enrollment: 92
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of small consumers of fruits and vegetables among children
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of small consumers of fruits and vegetables among adults (parents)
timeFrame: 12 months
measure: Utilization rate of vouchers (voucher arm)
timeFrame: 12 months
Other outcomes:
Locations:
city: Saint Denis
country: France
facility: Maison de la Santé
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.