Offering Free Fruits and Vegetables to Men at Risk of Poverty

Not Applicable

Completed

• Conditions: Dietary Habits

• Registration Number: NCT02787564
• Lead Sponsor: University of Hohenheim

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 €.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-05-25
• Study First Submitted QC: 2016-05-25
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Posted: 2016-06-01
• Results First Submitted: 2017-05-24
• Results First Submitted QC: 2017-05-24
• Results First Posted: 2017-10-13
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-06
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 61

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Amount of Fruits and Vegetables	baseline and 4 weeks	Change from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks
Variety of Fruits and Vegetables	baseline and 4 weeks	Change from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Nutritional Medicine, University of Hohenheim; 🇩🇪 Stuttgart, Germany