跳至主要内容
临床试验/NCT02362737
NCT02362737Unknown不适用

Active and Healthy Brotherhood: A Program for Chronic Disease Self-Management for Black Men

Gramercy Research Group2 个研究点 分布在 1 个国家目标入组 332 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
332
试验地点
2
主要终点
Change activity behavior (minutes per week in Total physical activity (PA) and light, moderate, vigorous PA).

研究概览

简要总结

This study will test ways to improve health behaviors using an intervention that has been specially designed for African-American men. The program, called Active & Healthy Brotherhood (AHB), will provide information on basic health, and healthy eating, physical activity, stress management, and how to get medical care when needed.The AHB intervention will be compared to a control group that will receive basic health information in videos and brochures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
21 Years 至 64 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • AA (based on self-report)
  • self-reported male
  • aged at least 21 years
  • non-institutionalized (i.e., community-dwelling, not living in assisted living facilities, nursing homes, etc.)
  • at high risk for developing chronic disease (e.g., not meeting current guidelines for PA and/or F&V intake; current smoker; diagnosed with high cholesterol) or
  • currently diagnosed with diabetes, hypertension, or cardiovascular disease
  • residents of Forsyth County, NC (or surrounding areas and able to attend group sessions in Forsyth County).

排除标准

  • have had a cardiovascular procedure (e.g., heart surgery), heart attack, heart failure, stroke in the last 6 months
  • have cognitive, visual, auditory, physical functional (e.g., unable to walk unassisted), or language impairment precluding participation in group discussion, learning activities, or data collection.
  • currently achieve >150 min/wk of moderate intensity PA or >75 min/wk of vigorous intensity PA AND currently consume > 9 servings of F&V daily.
  • are currently enrolled in a chronic disease management program.
  • are unwilling to accept randomization assignment or planning to move from local area in <2 years.
  • are currently receiving chemotherapy/radiation treatments.
  • Participants will be required to obtain approval from a health care provider prior to participation in the study if they:
  • are unable to participate in moderate PA due to physical limitations as indicated by positive (risk) responses on the PA Readiness Questionnaire (PAR-Q) and/or physician disapproval on the PAR Medical Examination.
  • have BP>180/>110 and/or HbA1C>12 and/or triglycerides >
  • have health conditions that could preclude changes to diet (e.g., irritable bowel syndrome, celiac disease)

结局指标

主要结局

Change activity behavior (minutes per week in Total physical activity (PA) and light, moderate, vigorous PA).

时间窗: baseline, 6 months, 12 months

Minutes per week in Total physical activity (PA) and light, moderate, vigorous PA

Change dietary intake (Fruit and vegetable servings, % fat, sodium and fiber intake).

时间窗: baseline, 6 months, 12 months

Fruit and vegetable servings, % fat, sodium and fiber intake

Change stress management.

时间窗: baseline, 6 months, 12 months

Identification of issues and strategies that affect stress management

Change sedentary behavior (minutes per week of sedentary behavior).

时间窗: baseline, 6 months, 12 months

Minutes per week of sedentary behavior

Change help-seeking behaviors (Medication adherence and doctor/ER visits).

时间窗: baseline, 6 months, 12 months

Medication adherence and doctor/ER visits

次要结局

  • Change body weight.(baseline, 6 months, 12 months)
  • Change blood glucose.(baseline, 6 months, 12 months)
  • Change blood pressure.(baseline, 6 months, 12 months)
  • Change HbA1c.(baseline, 6 months, 12 months)

研究者

发起方
Gramercy Research Group
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Active and Healthy Brotherhood: A Program for... | 临床试验