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Completed

NCT Number: NCT06156631

Uncontrolled Hypertension Management Among Jordanian Adults

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.

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Key information

Conditions

Hypertension Behavior Behavior, Animal Cardiovascular Diseases Dietary Habits Feeding Behavior Health Behavior Medication Adherence Motivational Interviewing Motor Activity Patient Acceptance of Health Care Patient Compliance Physical Activity Treatment Adherence and Compliance Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al Barha Health Center, Irbid, Jordan

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Dietary habits

    Time frame: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)

    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.

  2. Physical activity

    Time frame: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)

    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

  3. Medication adherence

    Time frame: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)

    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.

  4. Body mass index (BMI)

    Time frame: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)

    the output measure of dividing participant's weight in kilograms by their height in meters squared, or BMI = weight (in kg)/height2 (in m2).

  5. Waist circumference (WC)

    Time frame: At two points: pre-intervention (baseline) and post-intervention (after 10 weeks)

    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.

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Registry information

Official study title

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

Acronym: DASH-ExMAMI

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 5, 2023
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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