Offering Free Fruits and Vegetables to Men at Risk of Poverty
Studie Zum Einfluss Der Bereitstellung Von Kostenlosem Favorisiertem Obst Und Gemüse Auf Das Ernährungsverhalten
1 other identifier
interventional
61
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 25, 2016
CompletedFirst Posted
Study publicly available on registry
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedResults Posted
Study results publicly available
October 13, 2017
CompletedJune 28, 2018
May 1, 2018
4 months
May 25, 2016
May 24, 2017
May 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Variety of Fruits and Vegetables
Change from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks
baseline and 4 weeks
Amount of Fruits and Vegetables
Change from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks
baseline and 4 weeks
Secondary Outcomes (4)
Variety of Fruits and Vegetables Among Food Bank Users
baseline and 4 weeks
Amount of Fruits and Vegetables Among Food Bank Users
baseline and 4 weeks
Variety of Fruits and Vegetables Among Non-Food Bank Users
baseline and 4 weeks
Amount of Fruits and Vegetables Among Non-Food Bank Users
baseline and 4 weeks
Study Arms (2)
Free Fruit and Vegetables
EXPERIMENTALAfter 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.
Control Goup
NO INTERVENTIONAt 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- lives in assisted living accommodations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Nutritional Medicine, University of Hohenheim
Stuttgart, 70593, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof. Dr. Nanette Ströbele-Benschop
- Organization
- University of Hohenheim
Study Officials
- PRINCIPAL INVESTIGATOR
Nanette Stroebele-Benschop, PhD
Institute of Nutritional Medicine, University of Hohenheim
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 25, 2016
First Posted
June 1, 2016
Study Start
February 1, 2016
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
June 28, 2018
Results First Posted
October 13, 2017
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share