Uncontrolled Hypertension Management Among Jordanian Adults

NCT06156631 | Completed

• 1 other identifier: NM2991969
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (5)

• Dietary habits

  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)

• 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)

Study Arms (2)

Participants receive DASH-ExMAMI intervention.

EXPERIMENTAL

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.

Behavioral: DASH-ExMAMI

Participants who do not receive DASH-Ex MAMI

NO 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.

Interventions

DASH-ExMAMI BEHAVIORAL

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.

Also known as: Dietary approach to stop hypertension, exercise and medication adherence behavioral change

Participants receive DASH-ExMAMI intervention.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (4)

Al Barha Health Center

Irbid, 21191, Jordan

Location

Al Tattweer Al Hadhary Health Center

Irbid, 21191, Jordan

Location

Al Zahrawi Health Center

Irbid, 21191, Jordan

Location

Maruw Health Center

Irbid, 21191, Jordan

Location

MeSH Terms

Conditions

Hypertension; Motor Activity; Feeding Behavior; Medication Adherence

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior; Behavior, Animal; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: 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.

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: December 5, 2023
• Study Start: June 7, 2024
• Primary Completion: September 5, 2024
• Study Completion: October 7, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

JO (4)