Effect of Counselling Using Lifestyle Medicine Assessment Tool on Hypertensive Patients

Effect of Counselling of Patients With Hypertension Presenting in Family Medicine Clinics Using Lifestyle Medicine Assessment Tool.

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 is more satisfactory for them then 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.
• They will also be asked to measure their blood pressure at home and bring the record with them when they come for their doctor's visit.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Lifestyle Modification; Lifestyle Intervention; Counselling
• Intervention / Treatment: Behavioral: Lifestyle Intervention

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hafiz Muhammad Abubaker Mahmood, MBBS; Phone Number: +923213169048; Email: muhammad.abubaker@tih.org.pk

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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. They will be required to keep, and bring with them at each visit, a home BP log comprising of two readings taken one minute apart, twice a day (total four readings daily) for a minimum of 3 to 7 (preferred) days before the consultation. At the end of the study they will complete a satisfaction questionnaire.	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 receive the usual routine care. They will be required to keep, and bring with them at each visit, a home BP log comprising of two readings taken one minute apart, twice a day (total four readings daily) for a minimum of 3 to 7 (preferred) days before the consultation. At the end of the study they will complete a satisfaction questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in systolic blood pressure	Change in systolic blood pressure (clinic BP main and home BP supportive) 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
Patient satisfaction	Patient satisfaction measured at the three-month follow-up, using the "Short Assessment of Patient Satisfaction" questionnaire. It is a seven-item scale, with score ranging from 0 to 28,with a higher score indicating higher patient satisfaction	At the end of three-month follow-up

Collaborators and Investigators

• Sponsor: Indus Hospital and Health Network

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 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): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: lifestyle counselling of hypertensive patients; Lifestyle Medicine Assessment Tool
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• 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