Uncontrolled Hypertension Management Among Jordanian Adults

Hypertension Clinical Trial

— DASH-ExMAMI  

Official title:

An Evaluation of Newly Developed Multimodal Health Intervention Among Uncontrolled Hypertensive Jordanian Adults in Primary Health Care Setting

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06156631
• Other study ID #: NM2991969
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: Universiti Sains Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: October 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dietary Habits
• Hypertension
• Medication Adherence
• Motivational Interviewing
• Physical Activity

Intervention

Behavioral:
• DASH-ExMAMI
The DASH-ExMAMI consists of ten counseling and health education sessions that each last from 20 to 60 minutes over 10 weeks. The DASH domain will address the following subjects: getting started on DASH, making the move to DASH, tips to reduce salt and sodium, and a week with the DASH eating plan. The Exercise component consists of brisk walking for 30 minutes every day, five days a week. The medication adherence domain is based on the participant's Hill-Bone Compliance to High Blood Pressure Therapy Scale items and their scores. All domains of the intervention are stages and processes of change-matched ones and are provided through 10 motivational interviewing and counseling sessions.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Sains Malaysia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure (SBP)	the average measurement of systolic blood pressure in mmHg using valid automated blood pressure apparatus.	At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
Primary	Diastolic blood pressure (DBP)	the average measurement of diastolic blood pressure in mmHg using valid automated blood pressure apparatus.	At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
Secondary	Dietary habits	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.	At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
Secondary	Physical activity	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	At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
Secondary	Medication adherence	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.	At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
Secondary	Body mass index (BMI)	the output measure of dividing participant's weight in kilograms by their height in meters squared, or BMI = weight (in kg)/height2 (in m2).	At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
Secondary	Waist circumference (WC)	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.	At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)