Clinical trial NCT06156631: Uncontrolled Hypertension Management Among Jordanian Adults
Official title: An Evaluation of Newly Developed Multimodal Health Intervention Among Uncontrolled Hypertensive Jordanian Adults in Primary Health Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Physical Activity
Dietary Habits
Medication Adherence
Motivational Interviewing
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Quasi-experimental design will be used to test the efficacy of the intervention (DASH-ExMAMI) on participants. The participants will be allocated into experimental and control groups. The experimental group will complete dietary, physical activity, medication adherence, and anthropometric assessments before and after the intended intervention. Similarly, the control group will be subjected to dietary, physical activity, medication adherence, and anthropometric assessments before and after the intervention, as in the experimental group but receiving only a usual care (UC) as provided by the PHC. The intervention (DASH-ExMAMI) will last ten weeks (ten sessions) and will include DASH dietary instruction and meal planning, self-monitored brisk walking exercise, and a medication adherence intervention based on an individual MI counselling approach.
Primary purpose: SUPPORTIVE_CARE

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:

1. 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.
2. Evaluate the effectiveness of the DASH-ExMAMI intervention on systolic and diastolic blood pressure in adults with uncontrolled hypertension in Jordan.
3. Evaluate the effectiveness of the DASH-ExMAMI intervention on the dietary habits scores in adults with uncontrolled hypertension in Jordan.
4. Evaluate the effectiveness of the DASH-ExMAMI intervention on the physical activity scores in adults with uncontrolled hypertension in Jordan.
5. Evaluate the effectiveness of the DASH-ExMAMI intervention on medication adherence scores in adults with uncontrolled hypertension in Jordan.
6. Evaluate the impact of the DASH-ExMAMI intervention on body mass indices (BMI) and waist circumferences (WC) in adults with uncontrolled hypertension in Jordan

Eligibility criteria: Inclusion Criteria:

1. Patient's age between ≥ 18 and 65 years old.
2. Has had diagnosed with hypertension and has started his or her treatment plan.
3. 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.
4. Has no other comorbidities that contraindicate exercise or restrict DASH diet.
5. Written medical authorization (documented in patient's medical record) by the attending primary healthcare physician approving the patient's participation.

Exclusion Criteria:

1. Pregnant and postpartum women
2. 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.
3. Has history of cardio-pulmonary, renal, or musculoskeletal comorbidities that contraindicate exercise or DASH diet.
4. 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.

Primary outcomes:
measure: Systolic blood pressure (SBP)
timeFrame: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
measure: Diastolic blood pressure (DBP)
timeFrame: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
Secondary outcomes:
measure: Dietary habits
timeFrame: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
measure: Physical activity
timeFrame: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
measure: Medication adherence
timeFrame: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
measure: Body mass index (BMI)
timeFrame: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
measure: Waist circumference (WC)
timeFrame: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Al Barha Health Center
city: Irbid
country: Jordan
facility: Al Tattweer Al Hadhary Health Center
city: Irbid
country: Jordan
facility: Al Zahrawi Health Center
city: Irbid
country: Jordan
facility: Maruw Health Center
Study officials:
References: