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

Study Overview
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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.

Official Title
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Etude Fruits et Légumes à la Maison (FLAM)

Conditions
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Primary Prevention, Nutrition Policy

Intervention / Treatment
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* Other: Vouchers
* Other: Nutrition education


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vouchers<br>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 | Other: Vouchers<br>* 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.<br>Other: Nutrition education<br>* Nutrition education workshops taught by a dietician<br>|
| Other: Control<br>Families included in the control arm will only receive nutritional education | Other: Nutrition education<br>* Nutrition education workshops taught by a dietician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Utilization rate of vouchers (voucher arm) |  | 12 months |