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Offering Free Fruits and Vegetables to Men at Risk of Poverty

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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

Tracking Information
First Submitted Date  ICMJE May 25, 2016
First Posted Date  ICMJE June 1, 2016
Results First Submitted Date  ICMJE May 24, 2017
Results First Posted Date  ICMJE October 13, 2017
Last Update Posted Date June 28, 2018
Study Start Date  ICMJE February 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2018)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 25, 2016)
Fruit and Vegetable Consumption [ Time Frame: 4 weeks ]
The amount and variety of fruits and vegetables consumed over the 4-week intervention group compared to control group.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2018)
  • 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.
  • 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
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2016)
  • Fruit and Vegetable Consumption [ Time Frame: 8 weeks ]
    The amount and variety of fruits and vegetables consumed in the intervention group comparing baseline with intervention phase.
  • Food variety [ Time Frame: 8 weeks ]
    Changes to types of food consumed in the intervention group comparing the baseline period with the 4-week intervention phase.
  • Food bank visits [ Time Frame: 8 weeks ]
    The variety and amount of fruits and vegetables consumed in participants visiting food banks compared to participants not using food banks.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Offering Free Fruits and Vegetables to Men at Risk of Poverty
Official Title  ICMJE Studie Zum Einfluss Der Bereitstellung Von Kostenlosem Favorisiertem Obst Und Gemüse Auf Das Ernährungsverhalten
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Dietary Habits
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Intervention Group
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2016)
61
Original Estimated Enrollment  ICMJE
 (submitted: May 25, 2016)
100
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02787564
Other Study ID Numbers  ICMJE free F+V
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nanette Stroebele-Benschop, University of Hohenheim
Study Sponsor  ICMJE University of Hohenheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nanette Stroebele-Benschop, PhD Institute of Nutritional Medicine, University of Hohenheim
PRS Account University of Hohenheim
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP