- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02787564
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
Studieoversigt
Detaljeret beskrivelse
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 €.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Stuttgart, Tyskland, 70593
- Institute of Nutritional Medicine, University of Hohenheim
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
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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.
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Ingen indgriben: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Variety of Fruits and Vegetables
Tidsramme: baseline and 4 weeks
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Change from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks
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baseline and 4 weeks
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Amount of Fruits and Vegetables
Tidsramme: baseline and 4 weeks
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Change from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks
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baseline and 4 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Variety of Fruits and Vegetables Among Food Bank Users
Tidsramme: baseline and 4 weeks
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Change from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks among food bank users.
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baseline and 4 weeks
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Amount of Fruits and Vegetables Among Food Bank Users
Tidsramme: baseline and 4 weeks
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Change from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks among food bank users
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baseline and 4 weeks
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Variety of Fruits and Vegetables Among Non-Food Bank Users
Tidsramme: baseline and 4 weeks
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Change from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks among non-Ffood Bank Users
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baseline and 4 weeks
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Amount of Fruits and Vegetables Among Non-Food Bank Users
Tidsramme: baseline and 4 weeks
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Change from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks among non-Food Bank Users.
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baseline and 4 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Nanette Stroebele-Benschop, PhD, Institute of Nutritional Medicine, University of Hohenheim
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- free F+V
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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