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Completed

NCT Number: NCT02787564

Offering Free Fruits and Vegetables to Men at Risk of Poverty

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.

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Key information

Conditions

Dietary Habits Behavior Behavior, Animal Feeding Behavior

Age range

30 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Nutritional Medicine, University of Hohenheim

Stuttgart, 70593, Germany

About this study

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 €.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention Group

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Hohenheim

Other

Registry information

Official study title

Studie Zum Einfluss Der Bereitstellung Von Kostenlosem Favorisiertem Obst Und Gemüse Auf Das Ernährungsverhalten

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 1, 2016
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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