Adherence Dynamics for Whole Food Interventions in African-American Men (DAPH)
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About
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.
Full description
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.
Enrollment
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Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
37 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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