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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.
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 €.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Variety of Fruits and Vegetables | Change from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks | 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 | baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 4 weeks |
| Amount of Fruits and Vegetables Among Food Bank Users |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nanette Stroebele-Benschop, PhD | Institute of Nutritional Medicine, University of Hohenheim | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Nutritional Medicine, University of Hohenheim | Stuttgart | 70593 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Variety of Fruits and Vegetables | Change from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks | Posted | Mean | Standard Deviation | types/day | baseline and 4 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Nanette Ströbele-Benschop | University of Hohenheim | +49711 459 24260 | 24260 | N.Stroebele@uni-hohenheim.de |
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| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
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Change from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks among food bank users
| 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 | 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. | baseline and 4 weeks |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Participants |
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| Primary | Amount of Fruits and Vegetables | Change from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks | Posted | Mean | Standard Deviation | portions/day | baseline and 4 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | types/day | baseline and 4 weeks |
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| Secondary | 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 | Posted | Mean | Standard Deviation | portions/day | baseline and 4 weeks |
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| Secondary | 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 | Posted | Mean | Standard Deviation | types/day | baseline and 4 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | portions/day | baseline and 4 weeks |
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| 25 |
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| 25 |
| 0 |
| 25 |
| EG001 | 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. | 0 | 27 | 0 | 27 | 0 | 27 |
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