Offering Free Fruits and Vegetables to Men at Risk of Poverty

• ClinicalTrials.gov Identifier: NCT02787564
• Recruitment Status: Completed
• First Posted: June 1, 2016
• Results First Posted: October 13, 2017
• Last Update Posted: June 28, 2018
• Sponsor: University of Hohenheim
• Information provided by (Responsible Party): Nanette Stroebele-Benschop, University of Hohenheim

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Dietary Habits	Behavioral: Intervention Group	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Studie Zum Einfluss Der Bereitstellung Von Kostenlosem Favorisiertem Obst Und Gemüse Auf Das Ernährungsverhalten
• Study Start Date: February 2016
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: June 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Variety of Fruits and Vegetables [ Time Frame: baseline and 4 weeks ]
   Change from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks
2. Amount of Fruits and Vegetables [ Time Frame: baseline and 4 weeks ]
   Change from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks

Secondary Outcome Measures :

1. Variety of Fruits and Vegetables Among Food Bank Users [ Time Frame: baseline and 4 weeks ]
   Change from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks among food bank users.
2. Amount of Fruits and Vegetables Among Food Bank Users [ Time Frame: baseline and 4 weeks ]
   Change from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks among food bank users
3. Variety of Fruits and Vegetables Among Non-Food Bank Users [ Time Frame: 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
4. Amount of Fruits and Vegetables Among Non-Food Bank Users [ Time Frame: 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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

Germany

Institute of Nutritional Medicine, University of Hohenheim

Stuttgart, Germany, 70593

Sponsors and Collaborators

University of Hohenheim

Investigators

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

More Information

• Responsible Party: Nanette Stroebele-Benschop, Professor, University of Hohenheim
• ClinicalTrials.gov Identifier: NCT02787564
• Other Study ID Numbers: free F+V
• First Posted: June 1, 2016
• Results First Posted: October 13, 2017
• Last Update Posted: June 28, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Nanette Stroebele-Benschop, University of Hohenheim:

fruit, vegetables