Effect of Counselling Using Lifestyle Medicine Assessment Tool on Hypertensive Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIndus Hospital and Health Network
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Diagnosed secondary hypertension.
Moderate to severe CKD (eGFR <60 ml/min/1.73m2).
Moderate to severe ischemic heart disease.
Diabetes Mellitus requiring insulin.
Trial design
Design model
Parallel
Treatments tested in this trial
Lifestyle Intervention
BehavioralThe 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.
Treatment groups
126 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
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 monthsSecondary 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.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: