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

Primary Prevention Clinical Trial

— FLAM  

Official title:

Etude Fruits et Légumes à la Maison (FLAM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461238
• Other study ID #: UParis13
• Status: Completed
• Phase: N/A
• First received: May 27, 2015
• Last updated: September 29, 2017
• Start date: June 2015
• Est. completion date: July 2017

Study information

• Verified date: September 2017
• Source: University of Paris 13
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Nutrition Policy
• Primary Prevention

Intervention

Other:
• 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.
• Nutrition education
Nutrition education workshops taught by a dietician

Locations

Country	Name	City	State
France	Maison de la Santé	Saint Denis

Sponsors (6)

Lead Sponsor	Collaborator
University of Paris 13	Direction Générale de la Santé, France, Institut National de Prévention et d'Education pour la Sante, Maison de la Santé de la ville de Saint Denis, Programme Malin, Ville de Saint Denis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	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.	12 months
Secondary	Utilization rate of vouchers (voucher arm)		12 months