Offering Free Fruits and Vegetables to Men at Risk of Poverty

Study Overview
=================
Brief Summary
-----------------
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.

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 €.

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

Conditions
-----------------
Dietary Habits

Intervention / Treatment
-----------------
* Behavioral: Intervention Group


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Free Fruit and Vegetables<br>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<br>* 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.<br>|
| No Intervention: Control Goup<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fruit, vegetables