Uncontrolled Hypertension Management Among Jordanian Adults

Not Applicable

Completed

• Conditions: Physical Activity; Dietary Habits; Medication Adherence; Motivational Interviewing; Hypertension
• Interventions: Behavioral: DASH-ExMAMI

• Registration Number: NCT06156631
• Lead Sponsor: Universiti Sains Malaysia

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

Study Timeline

• Study First Submitted: 2023-11-19
• Study First Submitted QC: 2023-11-25
• Study First Posted: 2023-12-05
• Study Start: 2024-06-07
• Primary Completion: 2024-09-05
• Status Verified: 2024-10
• Study Completion: 2024-10-07
• Last Update Submitted: 2024-10-19
• Last Update Posted: 2024-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participants receive DASH-ExMAMI intervention.	DASH-ExMAMI	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.

Primary Outcome Measures

Name	Time	Method
Diastolic blood pressure (DBP)	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)	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 Outcome Measures

Name	Time	Method
Dietary habits	At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)	The scores obtained by the 'start the conversation- food frequency questionnaire ' STC-FFQ' which quantifies healthy and unhealthy food components consumed by the clients for the last week over a few months and gives a specific score for each component, with the summary score ranging from 0 to 16-the lowest score indicating the healthiest eating pattern.
Medication adherence	At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)	The scores obtained by the Hill-Bone Compliance to High Blood Pressure Therapy Scale (HB-HBP) which evaluates patient behaviors in three key areas of high blood pressure treatment: 1) reduced sodium intake, 2) appointment keeping, and 3) medication taking.
Body mass index (BMI)	At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)	the output measure of dividing participant's weight in kilograms by their height in meters squared, or BMI = weight (in kg)/height2 (in m2).
Waist circumference (WC)	At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)	The value of WC measurement for a participant at the end of normal breaths, horizontally to the floor level, and at the midpoint between the upper of the iliac crest and the lowest palpable rib in the mid axillary line.
Physical activity	At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)	The scores obtained by the international physical activity questionnaire -short form IPAQ-SF which inquiries about three distinct types of activity in three domains (leisure time, domestic/gardening, and work and transport-related activity, as well as sitting). Walking, moderate-intensity activities, and vigorous-intensity activities are the specific types of activity that are assessed; frequency (measured in days per week) and duration (minutes per day) are gathered individually for each specific type of activity. The higher the score- expressed in Metabolic Equivalent of Task (MET)-min per week, the more intense the physical activity

Trial Locations

Locations (4)

Al Barha Health Center; 🇯🇴 Irbid, Jordan

Al Tattweer Al Hadhary Health Center; 🇯🇴 Irbid, Jordan

Al Zahrawi Health Center; 🇯🇴 Irbid, Jordan

Maruw Health Center; 🇯🇴 Irbid, Jordan