Trial Outcomes & Findings for Offering Free Fruits and Vegetables to Men at Risk of Poverty (NCT NCT02787564)
NCT ID: NCT02787564
Last Updated: 2018-06-28
Results Overview
Change from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
61 participants
Primary outcome timeframe
baseline and 4 weeks
Results posted on
2018-06-28
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
29
|
|
Overall Study
COMPLETED
|
25
|
27
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Offering Free Fruits and Vegetables to Men at Risk of Poverty
Baseline characteristics by cohort
| Measure |
Free Fruit and Vegetables
n=25 Participants
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.
|
Control Goup
n=27 Participants
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.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.0 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
54.9 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
54.9 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 4 weeksChange from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks
Outcome measures
| Measure |
Intervention Group
n=25 Participants
received weekly 14 portions of free fresh fruits and vegetables over a period of four weeks
|
Control Group
n=27 Participants
did not receive free fresh fruits and vegetables
|
|---|---|---|
|
Variety of Fruits and Vegetables
|
2.6 types/day
Standard Deviation 3.2
|
-1.2 types/day
Standard Deviation 3.9
|
PRIMARY outcome
Timeframe: baseline and 4 weeksChange from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks
Outcome measures
| Measure |
Intervention Group
n=25 Participants
received weekly 14 portions of free fresh fruits and vegetables over a period of four weeks
|
Control Group
n=27 Participants
did not receive free fresh fruits and vegetables
|
|---|---|---|
|
Amount of Fruits and Vegetables
|
1.1 portions/day
Standard Deviation 2.5
|
-0.2 portions/day
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: baseline and 4 weeksChange from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks among food bank users.
Outcome measures
| Measure |
Intervention Group
n=12 Participants
received weekly 14 portions of free fresh fruits and vegetables over a period of four weeks
|
Control Group
n=12 Participants
did not receive free fresh fruits and vegetables
|
|---|---|---|
|
Variety of Fruits and Vegetables Among Food Bank Users
|
2.2 types/day
Standard Deviation 3.8
|
-1.9 types/day
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: baseline and 4 weeksChange from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks among food bank users
Outcome measures
| Measure |
Intervention Group
n=12 Participants
received weekly 14 portions of free fresh fruits and vegetables over a period of four weeks
|
Control Group
n=12 Participants
did not receive free fresh fruits and vegetables
|
|---|---|---|
|
Amount of Fruits and Vegetables Among Food Bank Users
|
0.6 portions/day
Standard Deviation 2.2
|
-0.2 portions/day
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: baseline and 4 weeksChange from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks among non-Ffood Bank Users
Outcome measures
| Measure |
Intervention Group
n=13 Participants
received weekly 14 portions of free fresh fruits and vegetables over a period of four weeks
|
Control Group
n=15 Participants
did not receive free fresh fruits and vegetables
|
|---|---|---|
|
Variety of Fruits and Vegetables Among Non-Food Bank Users
|
3.0 types/day
Standard Deviation 2.7
|
-0.7 types/day
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: baseline and 4 weeksChange from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks among non-Food Bank Users.
Outcome measures
| Measure |
Intervention Group
n=13 Participants
received weekly 14 portions of free fresh fruits and vegetables over a period of four weeks
|
Control Group
n=15 Participants
did not receive free fresh fruits and vegetables
|
|---|---|---|
|
Amount of Fruits and Vegetables Among Non-Food Bank Users
|
1.5 portions/day
Standard Deviation 2.7
|
-0.2 portions/day
Standard Deviation 0.8
|
Adverse Events
Free Fruit and Vegetables
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Goup
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof. Dr. Nanette Ströbele-Benschop
University of Hohenheim
Phone: +49711 459 24260
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place