Offering Free Fruits and Vegetables to Men at Risk of Poverty

NCT ID: NCT02787564

Last Updated: 2018-06-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-06-30

Brief Summary

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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

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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 €.

Conditions

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Dietary Habits

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Intervention Group

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Hohenheim

OTHER

Sponsor Role lead

Responsible Party

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Nanette Stroebele-Benschop

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nanette Stroebele-Benschop, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Nutritional Medicine, University of Hohenheim

Locations

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Institute of Nutritional Medicine, University of Hohenheim

Stuttgart, , Germany

Site Status

Countries

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Germany

Other Identifiers

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free F+V

Identifier Type: -

Identifier Source: org_study_id

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