Lifestyle InterventionNCT07449962
Effect of Counselling Using Lifestyle Medicine Assessment Tool on Hypertensive Patients
A study testing Lifestyle Intervention in people with Lifestyle Intervention and Lifestyle Modification, run by Indus Hospital and Health Network at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lifestyle Intervention, Lifestyle Modification, Hypertension
- What is being tested?
- Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 sitePakistan
- Study dates
- Jan 2027to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
Participants will be:
- Asked a few questions about their lifestyle and then they will be advised accordingly on ways to make it better.
- Being tested
- Lifestyle Intervention
- Keywords
- lifestyle counselling of hypertensive patients, Lifestyle Medicine Assessment Tool
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Lifestyle Intervention |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline to the three-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study startJan 2027 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lifestyle InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indus Hospital and Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Hafiz Muhammad Abu Baker Mahmood, Indus Hospital and Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449962
- Sponsor's protocol ID
- IHHN_IRB_2026_02_018
- Status last verified
- Sep 2026
- First submitted
- 27 Feb 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lifestyle Medicine Assessment Tool-Guided Counselling Compared to Usual Care Counselling in Adult Patients With Hypertension. A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT07449962
- Acronym / sponsor ID
- IHHN_IRB_2026_02_018
- Keywords
- lifestyle counselling of hypertensive patients, Lifestyle Medicine Assessment Tool
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Indus Hospital and Health NetworkUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Lifestyle InterventionPatients 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle InterventionThe 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. | Behavioural | Intervention Group |
Primary outcome
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.
1 secondary outcome
Change in lifestyle factors
Time frame: From baseline to the three-month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention in people with Lifestyle Intervention and Lifestyle Modification, run by Indus Hospital and Health Network at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hafiz Muhammad Abubaker Mahmood, MBBS (+923213169048, muhammad.abubaker@tih.org.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic blood pressure (time frame: From enrolment to the end of follow-up at three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.