Adherence Dynamics for Whole Food Interventions in African-American Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Tomato Product Intake Between Different Groups
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •prostate cancer diagnosis
- •other cancers < 5 yrs postdiagnosis except for melanoma
- •already consuming four 1/2 cup servings of tomato products/wk.
结局指标
主要结局
Tomato Product Intake Between Different Groups
时间窗: 3 months
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.
次要结局
- Diet Adherence to Tomato Product Consumption Between Different Groups(3 months)
- Consumption of Tomato Products Between Different Groups(3 months)
- Plasma Lycopene Concentration Between Different Groups(3 months)
- Differences in Dietary Lycopene Intake Between Different Groups(3 months)