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临床试验/NCT03339050
NCT03339050已完成不适用

Reducing Cardiovascular Risk of Mid-life and Older African Americans

Florida State University0 个研究点目标入组 221 人开始时间: 2008年6月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
221
主要终点
Decrease in total sugar intake (g) as assessed by the multiple pass 24 hour recall.

研究概览

简要总结

Diseases such as hypertension and stroke affect mid-life and older African Americans at higher rates than Whites, negatively affecting health status of this group. This project determine the effectiveness of a faith-based health intervention for mid-life and older African Americans using community-based participatory research approaches.

详细描述

Mid-life and older African Americans (AAs), a population that is increasing in number, have high rates of cardiovascular-related morbidity and mortality in relation to Whites. For this population, dietary and physical activity behaviors are related to the incidence of cardiovascular disease (CVD). Few tested health promotion interventions tailored for mid-life and older AAs are available yet churches have been shown to be an effective environment for AA health programs. Thus, the overall goal of this project is to reduce CVD risk factors in mid-life and older AAs through implementing and evaluating a church-based health intervention. Using the Transtheoretical Model of Behavior Change (TTM) and Socio-ecological theory (SE), the objectives of this project were to: 1) determine the effectiveness of a church-based intervention in relation to dietary behaviors (food choice, dietary quality), habitual physical activity) and CVD clinical risk factors of mid-life and older African Americans by increasing consumption of fruits, vegetables and calcium-rich foods; decreasing consumption of fat, sugar and sodium; increasing habitual physical activity; and improving selected clinical outcomes (blood pressure, body weight, glucose, among others); 2) identify the differential influence of program components of the intervention; 3) examine variables that might mediate the process of goal achievement; and 4) determine variables that are related to stage of change progression in goal achievement. Midlife and older AAs (n=221) from six churches, three treatment and three comparison, in North Florida were randomly selected from the churches, stratifying by age and gender. The intervention, Health for Hearts United, was developed using a community-based participatory approach and included literature-based conceptual elements of awareness building, clinical learning and efficacy development. Instruments included a food and lifestyle habits questionnaire (food frequency, NCI fruit and vegetable screener, NCI fat screener, physical activity items, TTM items, background characteristics, among others). Clinical data, including 24 hour recall, were collected from a subsample of participants (n=104). Data were collected at four points: Baseline, 6 ,18 and 24 month. The project was guided by research and community advisory committees.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 45 years of age or older
  • African American
  • member and regular attender of church (at least twice a month)
  • resident of Gadsden and Leon counties in North Florida.

排除标准

  • Under 45 years of age
  • not African American
  • not a member and regular attender of church
  • not a resident of Gadsden and Leon counties in North Florida.

研究组 & 干预措施

Health for Hearts United

Experimental

Health for Hearts United (HHU) is a 18-month church-based intervention to reduce CVD risk in mid-life and older African Americans.

干预措施: Health for Hearts United (Behavioral)

结局指标

主要结局

Decrease in total sugar intake (g) as assessed by the multiple pass 24 hour recall.

时间窗: Change from Baseline, 6 months, 18 months and 24 months

The multiple pass 24 hour food recall was taken on three days (two week days and one weekend day) by trained interviewers. Data were analyzed using Food Processor (Esha, Salem, Oregon). The unit of measure was grams (g).

Decrease in saturated fat intake (g) as assessed by the multiple pass 24 hour recall.

时间窗: Change from Baseline, 6 months, 18 months and 24 months

The multiple pass 24 hour food recall was taken on three days (two week days and one weekend day) by trained interviewers. Data were analyzed using Food Processor (Esha, Salem, Oregon). The unit of measure was grams (g).

Decrease in total sodium intake (g) as assessed by the multiple pass 24 hour recall.

时间窗: Change from Baseline, 6 months, 18 months and 24 months

The multiple pass 24 hour food recall was taken on three days (two week days and one weekend day) by trained interviewers. Data were analyzed using Food Processor (Esha, Salem, Oregon). The unit of measure was grams (g).

Increase in fruit and vegetable consumption assessed by a single item on number of servings of fruits and vegetables consumed daily.

时间窗: Change from Baseline, 6 months, 18 months and 24 months

The single item measure was "How many servings of fruits and vegetables do you usually eat each day?" The item had the following possible responses: zero, one, two, three, four, five and six or more servings daily. The range of scores was zero to six, with six representing the highest number of servings daily and zero representing the lowest.

次要结局

  • Decrease in girth circumference of abdomen (cm) as assessed using clinical measurements by trained staff.(Change from Baseline, 6 months, 18 months and 24 months)
  • Increase in habitual physical activity (total kilocalories per week) as assessed by the Yale Physical Activity Scale (YPAS).(Change from Baseline, 6 months, 18 months and 24 months)
  • Decrease in systolic and diastolic blood pressure (mmHg) as assessed using clinical measurements by trained staff.(Change from Baseline, 6 months, 18 months and 24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Penny Ralston

Professor and Dean Emeritus

Florida State University

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