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Offering Free Fruits and Vegetables to Men at Risk of Poverty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Nanette Stroebele-Benschop, 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.

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 €.

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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

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.



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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787564


Locations
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Germany
Institute of Nutritional Medicine, University of Hohenheim
Stuttgart, Germany, 70593
Sponsors and Collaborators
University of Hohenheim
Investigators
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Principal Investigator: Nanette Stroebele-Benschop, PhD Institute of Nutritional Medicine, University of Hohenheim
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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    Key Record Dates
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