Adherence Dynamics for Whole Food Interventions in African-American Men

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-04

Study Completion Date

2008-09-30

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.

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Tomato product

Motivational telephone counseling weekly

Group Type ACTIVE_COMPARATOR

Tomato Product

Intervention Type DIETARY_SUPPLEMENT

Motivational Telephone Counseling weekly

Control

No Motivation telephone Counseling

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

No Motivational telephone Counseling

Interventions

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Tomato Product

Motivational Telephone Counseling weekly

Intervention Type DIETARY_SUPPLEMENT

Control

No Motivational telephone Counseling

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Intervention group Control Group

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.

Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes