RecruitingNot ApplicableNCT06740708

Scaling Up Community-based Noncommunicable Disease Research Into Practice in Pokhara Metropolitan City of Nepal

Sponsor

Johns Hopkins Bloomberg School of Public Health

Enrollment

2,070 participants

Start Date

Apr 28, 2025

Study Type

INTERVENTIONAL

Conditions

Hypertension Type 2 Diabetes Mellitus (T2DM)Tobacco Smoking

Summary

The goal of this clinical trial is to evaluate whether a multifaceted community-based intervention, comprising 1) screening and lifestyle counseling by female community health volunteers (FCHVs); community health workers in Nepal, through home visits, and 2) regular Short Message Service (SMS) messages, can effectively reduce systolic blood pressure (SBP), lower fasting blood glucose, and increase smoking cessation rates among adults living in Pokhara with hypertension, type 2 diabetes, and smoking habits, respectively. The main research questions are: * Can FCHV home visits combined with regular mobile phone messages focused on blood pressure management reduce systolic blood pressure in adults with hypertension? * Can FCHV home visits combined with regular mobile phone messages focused on diabetes management lower fasting blood glucose levels in adults with type 2 diabetes? * Can FCHV home visits combined with regular mobile phone messages focused on smoking cessation increase the cessation rate among current smokers? Researchers will compare the intervention group with a usual care group, which does not receive regular FCHV home visits for managing the three aforementioned risk factors or mobile phone messages.

Eligibility

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether a community-based program can improve the management of high blood pressure, type 2 diabetes, and smoking in Nepal. You may be eligible if... - You are a registered voter in Pokhara and plan to stay in the city during the study - You have high blood pressure (140/90 mmHg or above on two separate readings), type 2 diabetes (confirmed by blood sugar tests), OR you are a current daily smoker You may NOT be eligible if... - Your blood pressure is extremely high (180/120 mmHg or above) or your blood sugar is dangerously high or low - You have a secondary cause of high blood pressure or a type of diabetes other than type 2 - You have acute symptoms that may require hospitalization (such as chest pain, shortness of breath, altered mental status) - You are pregnant or planning to become pregnant - A doctor has told you that you have a life expectancy of 6 months or less Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALSCALE-NCD

1. FCHV home visits every three months, including * For hypertension i. Blood pressure measurement with digital BP devices ii. Lifestyle counseling iii. Referral if uncontrolled BP (≥140/90 mmHg) for 3 months * For type 2 diabetes i. Fasting blood glucose measurement with glucometer ii. Lifestyle counseling focusing on diabetes management iii. Referral if uncontrolled diabetes (≥126mg/dl) for 3 months * For current smokers i. Smoking cessation counseling ii. Referral for nicotine replacement therapy if request by participants 2. Mobile phone messages, including * Lifestyle modification * Conveyed as voice or text messages, depending on participant preference