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Clinical Trials/NCT06156631
NCT06156631
Completed
Not Applicable

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

Universiti Sains Malaysia4 sites in 1 country126 target enrollmentJune 7, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
Universiti Sains Malaysia
Enrollment
126
Locations
4
Primary Endpoint
Diastolic blood pressure (DBP)
Status
Completed
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
June 7, 2024
End Date
October 7, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

NASIR AS'AD IBRAHIM MATANI

PhD student

Universiti Sains Malaysia

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Dietary habits(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))
  • Physical activity(At two points: pre-intervention (baseline) and post-intervention (after 10 weeks))

Study Sites (4)

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