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Offering Free Fruits and Vegetables to Men at Risk of Poverty

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ClinicalTrials.gov Identifier: NCT02787564
Recruitment Status : Completed
First Posted : June 1, 2016
Results First Posted : October 13, 2017
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Nanette Stroebele-Benschop, University of Hohenheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Dietary Habits
Intervention Behavioral: Intervention Group
Enrollment 61
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Free Fruit and Vegetables Control Goup
Hide Arm/Group Description

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 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.
Period Title: Overall Study
Started 32 29
Completed 25 [1] 27 [2]
Not Completed 7 2
[1]
n=12 food bank users; n=13 non-food bank users
[2]
n=12 food bank users; n=15 non-food bank users
Arm/Group Title Free Fruit and Vegetables Control Goup Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 25 27 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 27 participants 52 participants
55.0  (11.9) 54.9  (8.5) 54.9  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 52 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
25
 100.0%
27
 100.0%
52
 100.0%
1.Primary Outcome
Title Variety of Fruits and Vegetables
Hide Description Change from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks
Time Frame baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:
received weekly 14 portions of free fresh fruits and vegetables over a period of four weeks
did not receive free fresh fruits and vegetables
Overall Number of Participants Analyzed 25 27
Mean (Standard Deviation)
Unit of Measure: types/day
2.6  (3.2) -1.2  (3.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Group, Control Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Comparison of difference of fruit and vegetable variety between intervention group and control group.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Amount of Fruits and Vegetables
Hide Description Change from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks
Time Frame baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:
received weekly 14 portions of free fresh fruits and vegetables over a period of four weeks
did not receive free fresh fruits and vegetables
Overall Number of Participants Analyzed 25 27
Mean (Standard Deviation)
Unit of Measure: portions/day
1.1  (2.5) -0.2  (1.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Group, Control Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments Comparison of difference of fruit and vegetable amount between intervention group and control group.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Variety of Fruits and Vegetables Among Food Bank Users
Hide Description Change from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks among food bank users.
Time Frame baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:
received weekly 14 portions of free fresh fruits and vegetables over a period of four weeks
did not receive free fresh fruits and vegetables
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: types/day
2.2  (3.8) -1.9  (4.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Group, Control Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments Comparison of difference of fruit and vegetable variety between intervention group and control group.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Amount of Fruits and Vegetables Among Food Bank Users
Hide Description Change from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks among food bank users
Time Frame baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:
received weekly 14 portions of free fresh fruits and vegetables over a period of four weeks
did not receive free fresh fruits and vegetables
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: portions/day
0.6  (2.2) -0.2  (1.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Group, Control Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.443
Comments Comparison of difference of fruit and vegetable amount between intervention group and control group.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Variety of Fruits and Vegetables Among Non-Food Bank Users
Hide Description Change from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks among non-Ffood Bank Users
Time Frame baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:
received weekly 14 portions of free fresh fruits and vegetables over a period of four weeks
did not receive free fresh fruits and vegetables
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: types/day
3.0  (2.7) -0.7  (3.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Group, Control Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments Comparison of difference of fruit and vegetable variety between intervention group and control group.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Amount of Fruits and Vegetables Among Non-Food Bank Users
Hide Description Change from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks among non-Food Bank Users.
Time Frame baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:
received weekly 14 portions of free fresh fruits and vegetables over a period of four weeks
did not receive free fresh fruits and vegetables
Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: portions/day
1.5  (2.7) -0.2  (0.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Group, Control Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments Comparison of difference of fruit and vegetable amount between intervention group and control group.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Free Fruit and Vegetables Control Goup
Hide Arm/Group Description

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 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.
All-Cause Mortality
Free Fruit and Vegetables Control Goup
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/27 (0.00%) 
Hide Serious Adverse Events
Free Fruit and Vegetables Control Goup
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/27 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Free Fruit and Vegetables Control Goup
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/27 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof. Dr. Nanette Ströbele-Benschop
Organization: University of Hohenheim
Phone: +49711 459 24260 ext 24260
EMail: N.Stroebele@uni-hohenheim.de
Layout table for additonal information
Responsible Party: Nanette Stroebele-Benschop, University of Hohenheim
ClinicalTrials.gov Identifier: NCT02787564    
Other Study ID Numbers: free F+V
First Submitted: May 25, 2016
First Posted: June 1, 2016
Results First Submitted: May 24, 2017
Results First Posted: October 13, 2017
Last Update Posted: June 28, 2018