Offering Free Fruits and Vegetables to Men at Risk of Poverty

Dietary Habits Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02787564
• Other study ID #: free F+V
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: June 2016

Study information

• Verified date: May 2018
• Source: University of Hohenheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 €.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dietary Habits

Intervention

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.

Locations

Country	Name	City	State
Germany	Institute of Nutritional Medicine, University of Hohenheim	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
University of Hohenheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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