Effect of Counselling Using Lifestyle Medicine Assessment Tool on Hypertensive Patients

NCT07449962 | Not Yet Recruiting DMC

• 1 other identifier: IHHN_IRB_2026_02_018
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lifestyle Intervention; Lifestyle Modification; Hypertension; Counselling

Keywords

lifestyle counselling of hypertensive patients; Lifestyle Medicine Assessment Tool

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient satisfaction

  At the end of three-month follow-up

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indus Hospital and Health Network: lead

Study Sites (1)

The Indus Hospital Karachi

Karachi, Sindh, 07491, Pakistan

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Hafiz Muhammad Abubaker Mahmood, MBBS

CONTACT

+923213169048; muhammad.abubaker@tih.org.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 4, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)