Finding a Simple Message to Improve Dietary Quality for Cancer and Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Dietary Quality
研究概览
简要总结
We hypothesize that adding beneficial high fiber foods to the diet will result in better overall dietary quality (measured by the Alternate Healthy Eating Index), which has been shown to be associated with cancer, than either reducing saturated fat, or a combination of high fiber and low saturated fat.
详细描述
Summary of Grant:
Several studies have demonstrated that poor dietary quality is associated with obesity and certain cancers, such as gastrointestinal, colorectal, and hormonal cancers. Dietary interventions aimed at improving diet are plagued by poor adherence, possibly due to the complexity of changing multiple diet components. Complex public health messages are associated with worse adherence and reduced capacity to impact health outcomes. If a simple public health recommendation for diet was effective at changing multiple aspects of diet, adherence and impact could be maximized. However, research has yet to test which single dietary message has the greatest impact on overall diet quality, and consequently, potential for cancer and heart disease prevention. Thus far, dietary interventions have tested varying combinations of multiple recommendations; however, a single dietary recommendation may have a synergistic beneficial effect on other areas of diet, precluding the need to make the message overly complex.
The present study compares 3 dietary change conditions that are hypothesized to have high potential for synergistic effects on other unaddressed areas of diet, and consequently overall dietary quality. Patients were randomized to one of three arms:
- low saturated fat diet (≤7% of total calories);
- high fiber diet (≥30 grams of total fiber per day);
- combination arm: low saturated fat and high fiber.
Each participant was instructed to reduce calories by -500 kcal/day from his/her resting metabolic rate (RMR), but total calories was not less than 1200 calories per day.
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
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ≥25, and ≤
- •>=21 years of age, less than 81 years of age.
- •has primary care physician's approval to participate in all aspects of the study,
- •speaks, reads, and understands English at 6th grade level minimum
- •residing in local area for the duration of the study.
- •available for bi-monthly sessions (6 individual nutrition counseling visits)
排除标准
- •presence of a psychological disorder that will limit his/her ability to participate (such as an eating disorder, uncontrolled bipolar disorder)
- •unwilling to provide informed consent
- •presence of unstable medical disorder (e.g., uncontrolled hypertension, uncontrolled diabetes, etc), or a medical disorder associated with a life expectancy less than 2 years.
- •currently taking any medication known to affect weight or appetite
- •smokes more than 3 cigarettes a day on average
- •Has a dietary restriction that precludes changing to the healthy diet, i.e.; Crohn's disease, ulcerative colitis, renal disease, active diverticulitis, etc.
- •currently following a specific diet plan (low saturated fat/meat, or high fiber)
- •does not have a telephone
- •Pregnant, or planning to become pregnant (participant will be asked this question in telephone screening. If the participant becomes pregnant, they are asked to inform the principal investigator)
- •Has an active drug or alcohol problem within the past year -
结局指标
主要结局
Dietary Quality
时间窗: 6 mos
Dietary quality was measured by the Alternative Healthy Eating Index (AHEI), a scale of healthy eating that goes from zero to 80 (best score).
Dietary Quality, Possible Score From Zero to 80 (Best Quality Diet).
时间窗: 3 months
The AHEI consists of 8 components (eg, vegetables,trans fat). Each contributed 0-10 points to the total score; a score of 10 indicates that the recommendations were fully met, whereas a score of 0 represents the least healthy dietary behavior. Intermediate intakes were scored proportionately between 0 and 10. All component scores were summed to obtain a total AHEI score ranging from zero(worst) to 80(best).
次要结局
- Change in Weight From Baseline to 3 Months(3 months)
- Change in Weight From Baseline to 6 Months(6 months)
- Change in Calories From Baseline to 3 Months(3 months)
- Change in Calories From Baseline to 6 Months(6 months)