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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02787564

Enrollment

Registered

2016-06-01

Start date

2016-02-29

Completion date

2016-06-30

Last updated

2018-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Habits

Keywords

fruit, vegetables

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 €.

Interventions

BEHAVIORALIntervention 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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

30 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Variety of Fruits and Vegetables	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	baseline and 4 weeks	Change from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks

Secondary

Measure	Time frame	Description
Variety of Fruits and Vegetables Among Food Bank Users	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	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	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	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.

Countries

Germany

Participant flow

Participants by arm

Arm	Count
Free Fruit and Vegetables A total of four 24h-food-recall questionnaires will be administered to men (\>30 years, living alone) at risk of poverty over a period of approximately 8 weeks. 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 8-week period, a FFQ and a questionnaire on consumed fruit and vegetable amounts and variety will be administered. 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.	25
Control Goup Control Group: A total of four 24h-food-recall questionnaires will be administered to men (\>30 years, living alone) at risk of poverty over a period of approximately 8 weeks to assess their usual food intake. At baseline and at the end a 4-week period, a FFQ and a questionnaire on consumed fruit and vegetable amounts and variety will be administered.	27
Total	52

Baseline characteristics

Characteristic	Free Fruit and Vegetables	Control Goup	Total
Age, Continuous	55.0 years STANDARD_DEVIATION 11.9	54.9 years STANDARD_DEVIATION 8.5	54.9 years STANDARD_DEVIATION 10.2
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	25 Participants	27 Participants	52 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 25	0 / 27
other Total, other adverse events	0 / 25	0 / 27
serious Total, serious adverse events	0 / 25	0 / 27