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临床试验/NCT07201948
NCT07201948招募中不适用

Community Team Lifestyle Immersion Program for Chronic Disease Prevention and Control

Meharry Medical College1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
220
试验地点
1
主要终点
Systolic and Diastolic Blood Pressure Change

研究概览

简要总结

This project is focuses on reducing the risk and progression of hypertension among a population that records high incidence of hypertension and other chronic ailments such as heart disease, diabetes, kidney failure, and obesity, with similar control measures. Several clinical trials over the last five decades have emphasized the importance of supportive lifestyle modification in the control of chronic disease that include a healthy diet, physical activity, quitting tobacco use, reducing alcohol use to the minimum, self-management of the disease, and adequate sleep. Study participants will receive motivation and skill development support in additional to specific nutrition, physical fitness, and self-management counselling from certified experts. This intervention incorporates elements of the American Heart Association prescription for health, Life's Simple 7 (LS7) lifestyle modification, the Dietary Approaches to preventing Hypertension (DASH) eating plan.

After receiving these interventions, participants will be contacted at 3-months, 6-months, and 12-months for follow-up. They will complete similar surveys to be compared to determine impact on their hypertension.

This intervention is complementary to usual pharmaceutical hypertension management.

详细描述

African Americans continue to bear disproportionate chronic disease morbidity and mortality, and tend to report lower benefits from clinical trials that include lifestyle modifications in addition to pharmaceutical management. This project uses hypertension as an index case for other chronic ailments such as heart disease, diabetes, kidney failure, and obesity, especially as their control measures are similar. Several clinical trials over the last five decades have emphasized the importance of supportive lifestyle modification in the control of chronic disease that include a healthy diet, physical activity, quitting tobacco use, reducing alcohol use to the minimum, self-management of the disease, and adequate sleep. Although socioeconomic factors can impact disease management outcomes, African Americans may require additional motivational support to first accept the notion of change of lifestyle and to adhere to the changes that may be a major shift in their eating and exercise habits. The need to positively impact chronic disease, particularly hypertension, morbidity and morbidity in the African American population deserves both pharmaceutical and non-pharmaceutical approaches. This intervention incorporates elements of the American Heart Association prescription for health, Life's Simple 7 (LS7) lifestyle modification, the Dietary Approaches to Stop Hypertension (DASH) eating plan, provides the knowledge and skills necessary for success, and introduces the motivation boost of participating in teams of 4-6 participants. The primary intervention outcome is adherence to the seven elements of LS7, measured by LS7 Scores at enrollment, and at 6- and 12-months follow-up. Secondary outcomes will include changes in SBP/DBP, BMI, Waist girth, and A1C. The study shall compare Team versus Individual study arms for participants recruited and managed in the health center and the home settings separately and combined. Intermediate outcomes will include, and not limited to biomarkers such as urine sodium, serum Plasminogen activator inhibitor-1 (PAI-1) for hypertension, Interleukin 6 (IL6), and C-reactive protein (CRP) for obesity.

The goal is to enroll 220 participants, half from health institutions (Nashville General Hospital & Mathew Walker Comprehensive Health Center) and the other half from the community (MDHA residence, Health Fairs, Churches etc.). Half of the participants will be people already diagnosed with hypertension (BP 140/90 or higher, or on hypertension medication) and half will be those at increased risk of developing hypertension with BP measurement 130/80 and above.

The study will be implemented in three phases:

Phase 1: Health Behavior Assessment. Phase 2: Intervention Development. Phase 3: Intervention Effectiveness Evaluation.

Intervention:

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
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Reside in Davidson and surrounding counties of Tennessee.
  • •At least 30 years old.
  • •At increased risk for developing hypertension (already diagnosed or a strong family history).
  • •Be able to consent.
  • •Not planning to move from this study area in 12 months after enrollment.

排除标准

  • •Does not reside in Davidson and surrounding counties.
  • •Less than 30 years old, or older than 80 years.
  • •Not at assessed increased risk for hypertension.

研究组 & 干预措施

Team Group

Active Comparator

4-6 participants will be assigned to a Team. They will be instructed to work together and motivate each other to adhere to the intervention components, to attend intervention activities, and meet lifestyle modification goals.

They will receive the intervention knowledge and skills training from:

  • Dietician
  • Physical Fitness Trainer
  • cardiologist They will also receive other support to enhance their lifestyle immersion from the research team.

干预措施: Lifestyle Immersion Intervention that will address Nutrition, Physical Fitness, and BP Self-Monitoring3 Elements: (Behavioral)

Individual Group

Active Comparator

Individual participants will be instructed to self-motivate to adhere to the intervention components, to attend intervention activities, and meet lifestyle modification goals.

They will receive the intervention knowledge and skills training from:

  • Dietician
  • Physical Fitness Trainer
  • cardiologist They will also receive other support to enhance their lifestyle immersion from the research team.

干预措施: Lifestyle Immersion Intervention that will address Nutrition, Physical Fitness, and BP Self-Monitoring3 Elements: (Behavioral)

结局指标

主要结局

Systolic and Diastolic Blood Pressure Change

时间窗: 6 months & 12 months.

Systolic and Diastolic blood pressure change will be computed as: SBP (enrollment) - SBP (Follow-up) DBP (enrollment) - DBP (Follow-up)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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