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Completed

NCT Number: NCT02461238

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

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Key information

Conditions

Primary Prevention Nutrition Policy

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maison de la Santé

Saint-Denis, 930000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vouchers

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

Other

Nutrition education workshops taught by a dietician

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Utilization rate of vouchers (voucher arm)

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Paris 13

Other

Collaborators

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

Registry information

Official study title

Etude Fruits et Légumes à la Maison (FLAM)

Acronym: FLAM

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 3, 2015
Registry last updated
Oct 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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