Dietary HabitsNCT02787564
Offering Free Fruits and Vegetables to Men at Risk of Poverty
A study testing Intervention Group in people with Dietary Habits, run by University of Hohenheim at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits
- What is being tested?
- Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2016to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- lives in assisted living accommodations
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Nutritional Medicine, University of Hohenheim
Stuttgart, 70593
About this study
Official title: Studie Zum Einfluss Der Bereitstellung Von Kostenlosem Favorisiertem Obst Und Gemüse Auf Das Ernährungsverhalten
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.
Read the 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 €.
- Conditions
- Dietary Habits
- Being tested
- Intervention Group
- Keywords
- fruit, vegetables
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variety of Fruits and Vegetables
Change from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks
Measured: 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
Measured: baseline and 4 weeks
Secondary outcomes (4)
Variety of Fruits and Vegetables Among Food Bank Users
Change from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks among food bank users.
Measured: baseline and 4 weeks
Amount of Fruits and Vegetables Among Food Bank Users
Change from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks among food bank users
Measured: baseline and 4 weeks
Variety of Fruits and Vegetables Among Non-Food Bank Users
Change from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks among non-Ffood Bank Users
Measured: baseline and 4 weeks
Amount of Fruits and Vegetables Among Non-Food Bank Users
Change from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks among non-Food Bank Users.
Measured: baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startFeb 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nanette Stroebele-Benschop, University of Hohenheim
- Investigators
- Nanette Stroebele-Benschop, PhD, Principal investigator, Institute of Nutritional Medicine, University of Hohenheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787564
- Sponsor's protocol ID
- free F+V
- Status last verified
- May 2018
- First submitted
- 25 May 2016
- Last updated
- 28 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studie Zum Einfluss Der Bereitstellung Von Kostenlosem Favorisiertem Obst Und Gemüse Auf Das Ernährungsverhalten
- ClinicalTrials.gov ID
- NCT02787564
- Acronym / sponsor ID
- free F+V
- Conditions
- Dietary Habits
- Keywords
- fruit, vegetables
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 1 Jun 2016 (estimated)
- Results
- Posted 13 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 €.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free Fruit and Vegetables | Experimental | Behavioral: Intervention GroupAfter 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. |
| 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. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- lives in assisted living accommodations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupThe 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. | Behavioural | Free Fruit and Vegetables |
Primary outcome
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
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
4 secondary outcomes
Variety of Fruits and Vegetables Among Food Bank Users
Time frame: baseline and 4 weeks
Amount of Fruits and Vegetables Among Food Bank Users
Time frame: baseline and 4 weeks
Variety of Fruits and Vegetables Among Non-Food Bank Users
Time frame: baseline and 4 weeks
Amount of Fruits and Vegetables Among Non-Food Bank Users
Time frame: baseline and 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nanette Stroebele-Benschop, PhD principal investigator
Institute of Nutritional Medicine, University of Hohenheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Dietary Habits, run by University of Hohenheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variety of Fruits and Vegetables (time frame: baseline and 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2018.