Adherence Dynamics for Whole Food Interventions in African-American Men

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Adherence Dynamics for Whole Food Interventions in African-American Men

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Tomato Product
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: African-American men aged ≥ 50 yr who recently were found to have serum prostate specific antigen (PSA) concentrations of >2.5 ng/mL with negative prostate biopsy for prostate cancer. English literacy willing to consume tomato products on a regular basis. Exclusion Criteria: prostate cancer diagnosis other cancers < 5 yrs postdiagnosis except for melanoma already consuming four 1/2 cup servings of tomato products/wk.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tomato product<br>Motivational telephone counseling weekly | Dietary Supplement: Tomato Product<br>* Motivational Telephone Counseling weekly<br>* Other names: Intervention group;|
| Placebo Comparator: Control<br>No Motivation telephone Counseling | Dietary Supplement: Control<br>* No Motivational telephone Counseling<br>* Other names: Control Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer prevention