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

NCT02461238 | Completed

• 1 other identifier: UParis13
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Prevention; Nutrition Policy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Proportion of small consumers of fruits and vegetables among adults (parents)

  12 months

• Utilization rate of vouchers (voucher arm)

  12 months

Study Arms (2)

Vouchers

ACTIVE COMPARATOR

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; Other: Nutrition education

Control

OTHER

Families included in the control arm will only receive nutritional education

Other: Nutrition education

Interventions

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.

Vouchers

Nutrition education OTHER

Nutrition education workshops taught by a dietician

Control; Vouchers

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Stable housing

You may not qualify if:

• Parent is under 18
• Family having no permanent address or planned move within a year
• Consent form unsigned
• Higher household income of 1700 euros per month for single-parent family or higher than 2 000 euros for other families

Sponsors & Collaborators

• University of Paris 13: lead
• Direction Générale de la Santé, France: collaborator
• Maison de la Santé de la ville de Saint Denis: collaborator
• Ville de Saint Denis: collaborator
• Programme Malin: collaborator
• Institut National de Prévention et d'Education pour la Sante: collaborator

Study Sites (1)

Maison de la Santé

Saint-Denis, 930000, France

Location

Related Publications (3)

• 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.

  PMID: 32153939 DERIVED

• 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.

  PMID: 30480163 DERIVED

• 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.

  PMID: 30153820 DERIVED

MeSH Terms

Interventions

Nutrition Assessment

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 3, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 3, 2017

Record last verified: 2017-09

Locations

FR (1)