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The purposes of this study are to explore the dynamics of adherence, using a simple whole food intervention strategy, both prior to and during the intervention period and to identify nutrient shifts in self-selected diets and to determine health risks (blood pressure, hyperlipidemia, and body weight) that may have resulted from increased tomato product consumption.
African-American (AA) men suffer the greatest proportion of health disparities of any studied category and adherence to advice among this group has been vastly understudied.
Although there are several ongoing trials for behavioral change, either of diet or lifestyle, enrollment rates of AA men (< 25%) often provide insufficient numbers to evaluate adherence issues separately.
Tomatoes, more than lycopene alone, may have beneficial effects on prostate health, including BPH and prostate cancer. Efficacy trials would require long-term adherence to high levels of tomato product (TP) consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tomato product | Active Comparator | Motivational telephone counseling weekly |
|
| Control | Placebo Comparator | No Motivation telephone Counseling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tomato Product | Dietary Supplement | Motivational Telephone Counseling weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tomato Product Intake Between Different Groups | The intervention group: aimed to achieve the goal of more than five servings of TP/week while control group aimed to eat vegetable instead of tomatoes. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diet Adherence to Tomato Product Consumption Between Different Groups | Using 24-hr recall weekly, consumption of tomato product was measured by serving size. | 3 months |
| Consumption of Tomato Products Between Different Groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eunyoung Park, M.S. | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60606 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23200261 | Result | Park E, Stacewicz-Sapuntzakis M, Sharifi R, Wu Z, Freeman VL, Bowen PE. Diet adherence dynamics and physiological responses to a tomato product whole-food intervention in African-American men. Br J Nutr. 2013 Jun 28;109(12):2219-30. doi: 10.1017/S0007114512004436. Epub 2012 Nov 19. |
| Label | URL |
|---|---|
| Pubmed | View source |
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Medical Clinic from June 2007 to Aug 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Tomato Product | Tomato Product: Motivational Telephone Counseling weekly |
| FG001 | Control | No Motivation telephone Counseling Control: No Motivational telephone Counseling |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tomato Product | Tomato Product: Motivational Telephone Counseling weekly |
| BG001 | Control | No Motivation telephone Counseling Control: No Motivational telephone Counseling |
| 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 | Tomato Product Intake Between Different Groups | The intervention group: aimed to achieve the goal of more than five servings of TP/week while control group aimed to eat vegetable instead of tomatoes. | Posted | Mean | Standard Deviation | servings/week | 3 months |
|
3 months
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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 | Tomato Product | Tomato Product: Motivational Telephone Counseling weekly |
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The number of phone calls and collected diet recalls between groups was different because of concern that the control group would increase their tomato product intake.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Phyllis E. Bowen | University of Illinois at Chicago | 708-524-0586 | pbowen@uic.edu |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control | Dietary Supplement | No Motivational telephone Counseling |
|
|
Using 24-hr diet recall, types of tomato products were counted.
| 3 months |
| Differences in Dietary Lycopene Intake Between Different Groups | 3 months |
| Plasma Lycopene Concentration Between Different Groups | 3 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Diet Adherence to Tomato Product Consumption Between Different Groups | Using 24-hr recall weekly, consumption of tomato product was measured by serving size. | Unit: Number of Participants | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Consumption of Tomato Products Between Different Groups | Using 24-hr diet recall, types of tomato products were counted. | Posted | Number | participants | 3 months |
|
|
|
| Secondary | Differences in Dietary Lycopene Intake Between Different Groups | Posted | Mean | Standard Deviation | mg/day | 3 months |
|
|
|
| Secondary | Plasma Lycopene Concentration Between Different Groups | Posted | Mean | Standard Deviation | µmol/L | 3 months |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Control | No Motivation telephone Counseling Control: No Motivational telephone Counseling | 0 | 15 | 0 | 15 |
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| D008722 | Methods |