NCT02787564

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

October 13, 2017

Completed
Last Updated

June 28, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

May 25, 2016

Results QC Date

May 24, 2017

Last Update Submit

May 6, 2018

Conditions

Keywords

fruit, vegetables

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

EXPERIMENTAL

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

Control Goup

NO INTERVENTION

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.

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.

Free Fruit and Vegetables

Eligibility Criteria

Age30 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Results Point of Contact

Title
Prof. Dr. Nanette Ströbele-Benschop
Organization
University of Hohenheim

Study Officials

  • Nanette Stroebele-Benschop, PhD

    Institute of Nutritional Medicine, University of Hohenheim

    PRINCIPAL INVESTIGATOR

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

Locations