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NCT Number: NCT07449962

Effect of Counselling Using Lifestyle Medicine Assessment Tool on Hypertensive Patients

The goal of this clinical trial is to learn if knowing and understanding a patient's daily habits and then giving clear advice on what changes to make can help control blood pressure better than the routine way of advising people with high blood pressure. The main questions it aims to answer are:

* To learn if using the Lifestyle Medicine Assessment tool (A 21-item questionnaire) to understand the current lifestyle of people with hypertension and guide them accordingly, helps in lowering blood pressure more, as compared to routine advice? * To see if this way of guiding patients results in more positive lifestyle changes than routine advice? Researchers will compare two groups of people with hypertension. One will be guided after assessing their current lifestyle with the Lifestyle Medicine Assessment Tool and one will be given routine guidance. The researchers will then see which group had better blood pressure control.

Participants will be:

• Asked a few questions about their lifestyle and then they will be advised accordingly on ways to make it better.

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Key information

Conditions

Lifestyle Intervention Cardiovascular Diseases Counselling Hypertension Lifestyle Modification Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Indus Hospital Karachi

Karachi, Sindh, 07491, Pakistan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients aged 18-65 yrs with diagnosed primary/essential hypertension, defined as two or more clinic BP readings of ≥130/80 (ACC/AHA Guidelines).
  • If taking anti hypertensives, then on a stable regime i.e. no recent medication change for at least ≥4 weeks.
  • Willing and able to participate in the study.

Exclusion criteria

  • Diagnosed secondary hypertension.
  • Moderate to severe CKD (eGFR <60 ml/min/1.73m2).
  • Moderate to severe ischemic heart disease.
  • Diabetes Mellitus requiring insulin.
  • Major psychiatric disorder such as dementia or schizophrenia.
  • Pregnancy or Lactating mother.
  • Unable to participate in study/ Severe mobility limitation.

Treatment and study plan

Lifestyle Intervention

Behavioral

The intervention includes using the lifestyle Medicine Assessment Tool (LMA), a 21-item questionnaire, to assess the patient's current lifestyle and deliver structured counselling according to their scores in each domain. To keep the counselling consistent and standardized throughout the study a checklist will be formulated according to the current guidelines on lifestyle modification for hypertensive patients, consisting of counselling items pertaining to each domain, and it will be followed for all patients in the intervention group. This will be repeated at every monthly follow-up visit for three months.

Primary outcomes

  1. Change in systolic blood pressure

    Time frame: From enrolment to the end of follow-up at three months

    Change in systolic blood pressure from baseline to the third month, measured at monthly intervals. The effect of the intervention will be evaluated as the difference in mean change between the intervention and control groups over time.

Secondary outcomes

  1. Change in lifestyle factors

    Time frame: From baseline to the three-month follow-up.

    Change in lifestyle factors of the control and intervention group, as measured by the total and domain scores of Lifestyle Medicine Assessment Tool.

Study contacts

Contact information is provided by the study sponsor or research team.

Hafiz Muhammad Abubaker Mahmood, MBBS

CONTACT

[email protected]

+923213169048

Sponsors and collaborators

Lead sponsor

Indus Hospital and Health Network

Other

Registry information

Official study title

Effect of Lifestyle Medicine Assessment Tool-Guided Counselling Compared to Usual Care Counselling in Adult Patients With Hypertension. A Randomized Control Trial.

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2026
Registry last updated
Sep 16, 2026

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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