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Not yet recruitingNCT07449962Updated Sep 16, 2026

Effect of Counselling Using Lifestyle Medicine Assessment Tool on Hypertensive Patients

An interventional study of Lifestyle Intervention in Lifestyle Intervention, Lifestyle Modification and Hypertension, sponsored by Indus Hospital and Health Network. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Indus Hospital and Health Network · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.
02

Conditions studied

  • Lifestyle Intervention
  • Lifestyle Modification
  • Hypertension
  • Counselling

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Keywords

  • lifestyle counselling of hypertensive patients
  • Lifestyle Medicine Assessment Tool
03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's planned enrollment of 126 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Indus Hospital and Health Network is the lead sponsor of 20 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Diagnosed secondary hypertension.
  2. Moderate to severe CKD ( \<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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
126 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralLifestyle 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.

06

What researchers measure

Primary outcomes

  1. Change in systolic blood pressure

    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.

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

Secondary outcomes

  1. Change in lifestyle factors

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

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

07

Study locations

1 site
  • The Indus Hospital Karachi
    Karachi, Sindh 07491, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07449962
Lead sponsor
Indus Hospital and Health Network
Responsible party
Dr. Hafiz Muhammad Abu Baker Mahmood (Principal Investigator, Indus Hospital and Health Network) — Principal investigator
First posted
Mar 4, 2026
Start date
Jan 2027 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 16, 2026

Study contacts

Hafiz Muhammad Abubaker Mahmood, MBBS
Contact
muhammad.abubaker@tih.org.pk
+923213169048

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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