Uncontrolled Hypertension Management Among Jordanian Adults

NCT ID: NCT06156631

Last Updated: 2024-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-07

Study Completion Date

2024-10-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension Physical Activity Dietary Habits Medication Adherence Motivational Interviewing

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

DASH-ExMAMI

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Dietary approach to stop hypertension, exercise and medication adherence behavioral change

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universiti Sains Malaysia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

NASIR AS'AD IBRAHIM MATANI

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Al Barha Health Center

Irbid, , Jordan

Site Status

Al Tattweer Al Hadhary Health Center

Irbid, , Jordan

Site Status

Al Zahrawi Health Center

Irbid, , Jordan

Site Status

Maruw Health Center

Irbid, , Jordan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Jordan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NM2991969

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mobile Health Management of Hypertension
NCT05856955 NOT_YET_RECRUITING NA
Behavioral Study to Control Blood Pressure
NCT01035554 COMPLETED PHASE2/PHASE3