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

September 29, 2017 updated by: Serge HERCBERG, University of Paris 13

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint Denis, France, 930000
        • Maison de la Santé

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 10 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of small consumers of fruits and vegetables among adults (parents)
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.
12 months
Utilization rate of vouchers (voucher arm)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Paris 13

Collaborators

Institut national de prevention et d'education pour la sante
Direction Générale de la Santé, France
Maison de la Santé de la ville de Saint Denis
Ville de Saint Denis
Programme Malin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

May 27, 2015

First Submitted That Met QC Criteria

May 29, 2015

First Posted (Estimate)

June 3, 2015

Study Record Updates

Last Update Posted (Actual)

October 3, 2017

Last Update Submitted That Met QC Criteria

September 29, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • UParis13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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