HypertensionDASH-ExMAMINCT06156631
Uncontrolled Hypertension Management Among Jordanian Adults
A study testing DASH-ExMAMI in people with Hypertension and Physical Activity, run by Universiti Sains Malaysia at 4 sites in Jordan.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension, Physical Activity, Dietary Habits
- What is being tested?
- DASH-ExMAMI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 4 sitesJordan
- Study dates
- 7 Jun 2024to 7 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Jordan4 sites
Al Barha Health Center
Irbid, 21191
Al Tattweer Al Hadhary Health Center
Irbid, 21191
Al Zahrawi Health Center
Irbid, 21191
Maruw Health Center
Irbid, 21191
About this study
Official title: An Evaluation of Newly Developed Multimodal Health Intervention Among Uncontrolled Hypertensive Jordanian Adults in Primary Health Care Setting
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.
Read the detailed description
This interventional study specifically aims to:
- 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.
- Evaluate the effectiveness of the DASH-ExMAMI intervention on systolic and diastolic blood pressure in adults with uncontrolled hypertension in Jordan.
- Evaluate the effectiveness of the DASH-ExMAMI intervention on the dietary habits scores in adults with uncontrolled hypertension in Jordan.
- Evaluate the effectiveness of the DASH-ExMAMI intervention on the physical activity scores in adults with uncontrolled hypertension in Jordan.
- Evaluate the effectiveness of the DASH-ExMAMI intervention on medication adherence scores in adults with uncontrolled hypertension in Jordan.
- 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
- Hypertension, Physical Activity, Dietary Habits, Medication Adherence, Motivational Interviewing
- Being tested
- DASH-ExMAMI
- Medical subject headings
- Hypertension, Motor Activity, Feeding Behavior, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH-ExMAMIBehavioural
Also called Dietary approach to stop hypertension, exercise and medication adherence behavioral change
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure (SBP)
the average measurement of systolic blood pressure in mmHg using valid automated blood pressure apparatus.
Measured: 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.
Measured: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
Secondary outcomes (5)
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.
Measured: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
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
Measured: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
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.
Measured: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
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).
Measured: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
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.
Measured: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start7 Jun 2024
- Primary completion5 Sep 2024
- Study completion7 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NASIR AS'AD IBRAHIM MATANI, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156631
- Sponsor's protocol ID
- NM2991969
- Acronym
- DASH-ExMAMI
- Status last verified
- Oct 2024
- First submitted
- 19 Nov 2023
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Newly Developed Multimodal Health Intervention Among Uncontrolled Hypertensive Jordanian Adults in Primary Health Care Setting
- ClinicalTrials.gov ID
- NCT06156631
- Acronym / sponsor ID
- DASH-ExMAMI / NM2991969
- Conditions
- Hypertension, Physical Activity, Dietary Habits, Medication Adherence, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 7 Oct 2024 (actual)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Evaluate the effectiveness of the DASH-ExMAMI intervention on systolic and diastolic blood pressure in adults with uncontrolled hypertension in Jordan.
- Evaluate the effectiveness of the DASH-ExMAMI intervention on the dietary habits scores in adults with uncontrolled hypertension in Jordan.
- Evaluate the effectiveness of the DASH-ExMAMI intervention on the physical activity scores in adults with uncontrolled hypertension in Jordan.
- Evaluate the effectiveness of the DASH-ExMAMI intervention on medication adherence scores in adults with uncontrolled hypertension in Jordan.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Participants receive DASH-ExMAMI intervention. | Experimental | Behavioral: DASH-ExMAMIJordanian 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DASH-ExMAMIAlso: Dietary approach to stop hypertension, exercise and medication adherence behavioral changeThe 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. | Behavioural | Participants receive DASH-ExMAMI intervention. |
Primary outcome
Systolic blood pressure (SBP)
Time frame: 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.
Diastolic blood pressure (DBP)
Time frame: 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.
5 secondary outcomes
Dietary habits
Time frame: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
Physical activity
Time frame: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
Medication adherence
Time frame: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
Body mass index (BMI)
Time frame: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
Waist circumference (WC)
Time frame: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DASH-ExMAMI in people with Hypertension and Physical Activity, run by Universiti Sains Malaysia at 4 sites in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (SBP) (time frame: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.