Effect of Counselling Using Lifestyle Medicine Assessment Tool on Hypertensive Patients

September 11, 2026 updated by: Dr. Hafiz Muhammad Abu Baker Mahmood, Indus Hospital and Health Network

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 07491
        • The Indus Hospital Karachi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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).
  2. If taking anti hypertensives, then on a stable regime i.e. no recent medication change for at least ≥4 weeks.
  3. Willing and able to participate in the study.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Patients in the intervention group will complete the Lifestyle Medicine Assessment (LMA) questionnaire, and structured counselling will be delivered 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.
Behavioral: Lifestyle Intervention
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.
No Intervention: Control Group
The patients in the control group will complete the LMA questionnaire and their scores will be noted without revealing them to the participants. They will receive the usual routine counselling comprised of advice to reduce salt intake and increase daily physical activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrolment to the end of follow-up at three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to the three-month follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indus Hospital and Health Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 11, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IHHN_IRB_2026_02_018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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