An Evaluation of Newly Developed Multimodal Health Intervention Among Uncontrolled Hypertensive Jordanian Adults in Primary Health Care Setting
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universiti Sains Malaysia
- Enrollment
- 126
- Locations
- 4
- Primary Endpoint
- Diastolic blood pressure (DBP)
Study Overview
Brief Summary
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.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Participants receive DASH-ExMAMI intervention.
Jordanian participants who are adults (age between ≥ 18 and 65 years), have had diagnosed with hypertension and has started his or her treatment plan, and have 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 centre.
Intervention: DASH-ExMAMI (Behavioral)
Participants who do not receive DASH-Ex MAMI
Jordanian participants who are adults (age between ≥ 18 and 65 years), have had diagnosed with hypertension and has started his or her treatment plan, and have 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 centre.
Outcomes
Primary Outcomes
Diastolic blood pressure (DBP)
Time Frame: 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)
Time Frame: 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.
Secondary Outcomes
- 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))
Investigators
NASIR AS'AD IBRAHIM MATANI
PhD student
Universiti Sains Malaysia