Offering Free Fruits and Vegetables to Men at Risk of Poverty

Studie Zum Einfluss Der Bereitstellung Von Kostenlosem Favorisiertem Obst Und Gemüse Auf Das Ernährungsverhalten

The study aims to investigate whether the provision of free fresh fruits and vegetables to middle-aged men at risk of poverty increases their fruit and vegetable intake over a period of 4 weeks.

Study Overview

• Status: Completed
• Conditions: Dietary Habits
• Intervention / Treatment: Behavioral: Intervention Group

Detailed Description

A total of 100 men (> 30 years, living alone) with a low SES will be randomly assigned to a control or intervention group while controlling for food bank use. The intervention group will receive free fresh fruits and vegetables consisting of 2 daily portions of their favorite variety over a period of 4 weeks which will be provided to them once per week.

All participants will be asked to fill out a demographic questionnaire as well as a Food Frequency Questionnaire (FFQ), a questionnaire on variety of fruits and vegetables consumed and a 24-h-food-recall questionnaire. All questionnaires will be administered by trained interviewers. During the study period, the 24h-food recall questionnaire will be administered four more times; two times before the 4-week intervention period and two times after the intervention period. After the 4-week intervention period, interviewers will administered the FFQ and the questionnaire on variety.

Participants assigned to the control group will receive a fruit and vegetable basket after 4 weeks after baseline.

All participants will receive gift certificates for local supermarkets in the amount of 35,00 €.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Stuttgart, Germany, 70593
    • Institute of Nutritional Medicine, University of Hohenheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• income below 980 € per month
• > 30 years of age
• living alone
• without regular food delivery service (except for e.g. meals on wheels once a day)
• born in Germany
• speaks German

Exclusion Criteria:

• lives in assisted living accommodations

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Free Fruit and Vegetables; After baseline assessment of food intake patterns, the intervention will consist of providing free fruits and vegetables of their choice for a period of four weeks which will be provided fresh each week. At baseline and at the end of the 4-week period, a FFQ, two 24h-recalls and a questionnaire on consumed fruit and vegetable variety will be administered.	Behavioral: Intervention Group; The intervention consists of providing free fruits and vegetables of the participants' liking for a period of 4 weeks. Each week, a total of 2 portions of either fruits and/or vegetables per day will be provided.
No Intervention: Control Goup; At baseline and at the end of the 4-week period, a FFQ, four 24h-recalls and a questionnaire on consumed fruit and vegetable variety will be administered. At the end of the intervention period they receive once a basket of free fruits and vegetables.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variety of Fruits and Vegetables	Change from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks	baseline and 4 weeks
Amount of Fruits and Vegetables	Change from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks	baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variety of Fruits and Vegetables Among Food Bank Users	Change from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks among food bank users.	baseline and 4 weeks
Amount of Fruits and Vegetables Among Food Bank Users	Change from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks among food bank users	baseline and 4 weeks
Variety of Fruits and Vegetables Among Non-Food Bank Users	Change from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks among non-Ffood Bank Users	baseline and 4 weeks
Amount of Fruits and Vegetables Among Non-Food Bank Users	Change from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks among non-Food Bank Users.	baseline and 4 weeks

Collaborators and Investigators

• Sponsor: University of Hohenheim
• Investigators: Principal Investigator: Nanette Stroebele-Benschop, PhD, Institute of Nutritional Medicine, University of Hohenheim

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: May 25, 2016
• First Submitted That Met QC Criteria: May 25, 2016
• First Posted (Estimate): June 1, 2016

Study Record Updates

• Last Update Posted (Actual): June 28, 2018
• Last Update Submitted That Met QC Criteria: May 6, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: fruit, vegetables
• Other Study ID Numbers: free F+V

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO