An Evaluation of Newly Developed Multimodal Health Intervention Among Uncontrolled Hypertensive Jordanian Adults in Primary Health Care Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 8
- 主要终点
- Diastolic blood pressure (DBP)
研究概览
简要总结
This study will evaluate a newly developed multimodal health intervention including dietary approach to stop hypertension (DASH) diet, exercise (Ex), and medication adherence (MA) using motivational interviewing (MI) counselling (DASH-Ex MAMI) for hypertensive Jordanian adults in primary care settings.
详细描述
This interventional study specifically aims to:
- Develop a valid multimodal health intervention that includes DASH, exercise, and medication adherence using MI counselling (DASH-ExMAMI) for hypertensive Jordanian adults in primary care settings.
- Evaluate the effectiveness of the DASH-ExMAMI intervention on systolic and diastolic blood pressure in adults with uncontrolled hypertension in Jordan.
- Evaluate the effectiveness of the DASH-ExMAMI intervention on the dietary habits scores in adults with uncontrolled hypertension in Jordan.
- Evaluate the effectiveness of the DASH-ExMAMI intervention on the physical activity scores in adults with uncontrolled hypertension in Jordan.
- Evaluate the effectiveness of the DASH-ExMAMI intervention on medication adherence scores in adults with uncontrolled hypertension in Jordan.
- Evaluate the impact of the DASH-ExMAMI intervention on body mass indices (BMI) and waist circumferences (WC) in adults with uncontrolled hypertension in Jordan
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
A single-blind method will be used for the main outcome measure (BP) in this study. Blood pressure and the anthropometric measurements (height, weight, and waist circumference) will be assessed by a research assistant who doesn't know which group a participant belongs to. However, an open-label method will be applied for the other outcome measures: dietary habits, physical activity, and medication adherence.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient's age between ≥ 18 and 65 years old.
- •Has had diagnosed with hypertension and has started his or her treatment plan.
- •Has uncontrolled hypertension: The average systolic blood pressure reading that is equal to or higher than 130 mmHg and/or diastolic blood pressure that is equal to or higher than 90 mmHg for the last two patients' records available at the health center.
- •Has no other comorbidities that contraindicate exercise or restrict DASH diet.
- •Written medical authorization (documented in patient's medical record) by the attending primary healthcare physician approving the patient's participation.
排除标准
- •Pregnant and postpartum women
- •Has severe hypertension (SBP≥ 200 or DBP ≥110). Resting SBP greater than 200mm Hg or DBP greater than 110mm Hg is a relative contraindication to exercise stress testing.
- •Has history of cardio-pulmonary, renal, or musculoskeletal comorbidities that contraindicate exercise or DASH diet.
- •This research will exclude all clients who are contraindicated to undergo treadmill tests with extra precautions: history of myocardial infarction within six months, angina, cardiac dysrhythmias, symptomatic aortic stenosis, and heart failure, pulmonary embolus, infarction or hypertension, myocarditis or pericarditis, or endocarditis, aortic dissection, history of renal impairment, brittle diabetes mellitus, bronchial asthma, musculoskeletal problems that might worsen by exercise, and mental health problems that interfere with the comprehension of the intervention and its related safety measures. Clients with a history of metabolic disorders and who follow a specific diet restriction will also be excluded such as celiac disease.
结局指标
主要结局
Diastolic blood pressure (DBP)
时间窗: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
the average measurement of diastolic blood pressure in mmHg using valid automated blood pressure apparatus.
Systolic blood pressure (SBP)
时间窗: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
the average measurement of systolic blood pressure in mmHg using valid automated blood pressure apparatus.
次要结局
- Dietary habits(At two points: pre-intervention (baseline) and post-intervention (after 10 weeks))
- Medication adherence(At two points: pre-intervention (baseline) and post-intervention (after 10 weeks))
- Body mass index (BMI)(At two points: pre-intervention (baseline) and post-intervention (after 10 weeks))
- Waist circumference (WC)(At two points: pre-intervention (baseline) and post-intervention (after 10 weeks))
- Physical activity(At two points: pre-intervention (baseline) and post-intervention (after 10 weeks))
研究者
NASIR AS'AD IBRAHIM MATANI
PhD student
Universiti Sains Malaysia