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

Tracking Information

• First Submitted Date: May 25, 2016
• First Posted Date: June 1, 2016
• Results First Submitted Date: May 24, 2017
• Results First Posted Date: October 13, 2017
• Last Update Posted Date: June 28, 2018
• Study Start Date: February 2016
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: Offering Free Fruits and Vegetables to Men at Risk of Poverty
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: 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.

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 2, 2016): 61
• Original Estimated Enrollment (submitted: May 25, 2016): 100
• Actual Study Completion Date: June 2016
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 30 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT02787564
• Other Study ID Numbers: free F+V
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Nanette Stroebele-Benschop, University of Hohenheim
• Study Sponsor: University of Hohenheim
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Hohenheim
• Verification Date: May 2018