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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Tobacco Smoking; Type 2 Diabetes Mellitus (T2DM)
• Intervention / Treatment: Behavioral: SCALE-NCD

Detailed Description

Background: Rapid globalization and urbanization continue to escalate the burden of non-communicable diseases (NCDs) across the world, disproportionally affecting low- and middle-income countries (LMICs). To date, trials have documented that task-sharing with community health workers (CHWs) can reduce systolic blood pressure and fasting blood glucose and achieve smoking cessation. However, most trials have been done in rural settings, and only focused on managing a single condition, such as hypertension. Furthermore, despite increasing evidence of the effectiveness from clinical trials, there is a lack of studies exploring best practices for 'how' to implement and sustain these interventions in LMICs.

Study Design: Type 2 hybrid effectiveness-implementation research study containing 1) a qualitative study, 2) open-label, two-armed, cluster randomized controlled trial (cRCT), and 3) implementation research plan. The details of the c-RCT only are presented below.

Settings: Pokhara Metropolitan City of Nepal. Pokhara is the second largest city in Nepal containing 33 administrative units called "wards". The investigators consider wards as clusters and randomize these 30 clusters (28 independent wards and 2 combined wards) into intervention and control groups in a 1:1 ratio.

Participants: Adults with ages between 40-75 having at least one of the following conditions:

• Hypertension, defined as:

  i. BP≥140/90 mmHg at two separate measures, or ii. Under pharmacotherapy for hypertension

• Type 2 diabetes mellitus, defined as i. Fingerprick glucose (fasting) ≥100 mg/dl, plasma glucose (fasting) ≥126 mg/dL, and ii. HbA1c ≥ 6.5 %, or iii. Under pharmacotherapies for type 2 diabetes
• Current tobacco smoking, defined as i. Ever smoked ≥100 cigarettes in lifetime, and ii. Currently smokes every day or on some days.

Intervention: Multifaceted intervention containing the following two components:

1. FCHV home visits every three months
2. Mobile phone messages, including

Control: Usual care in Pokhara Metropolitan City in Nepal, which does not include FCHV home visits for management of hypertension, diabetes, or smoking, and mobile phone messages.

Outcome: Changes in systolic blood pressure, fasting blood glucose, and smoking cessation at 6 months post randomization will be measured as primary outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 2070
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dinesh Neupane, PhD; Phone Number: 410-502-9170; Email: dneupan2@jhu.edu

Study Locations

• Nepal
  • Gandaki
    • Pokhara, Gandaki, Nepal
      • Recruiting
      • Pokhara Metropolitan City
      • Contact: Sweta Koirala, PhD; Phone Number: +977014500022; Email: info@nedsnepal.org.np

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Meeting at least one of the following three conditions

   • Hypertensive, defined as
   • BP≥140/90 mmHg at two separate measurements
   • Type 2 diabetes, defined as
   • Fingerprick glucose≥100 mg/dL, and plasma fasting glucose ≥126 mg/dL, and HbA1c≥6.5
   • Current smoker, defined as
   • Ever smoked ≥100 cigarettes in lifetime, and
   • Currently smokes every day.
2. Registered on the voter list in Pokhara.
3. Not planning to migrate outside of Pokhara during the study period

Exclusion Criteria:

1. Blood pressure ≥180/120 mmHg or
2. Blood glucose >250 mg/dL or <54 mg/dL
3. Diagnosed with secondary hypertension by health professionals
4. Diagnosed with other diabetes besides type 2 by health professionals

5. Presenting with acute symptoms that may require hospitalizations, which includes but not limited to:

   • Nausea, vomiting, diarrhea
   • Abdominal pain
   • Polyuria, polydipsia, polyphagia
   • Loss of motor or sensory function
   • Altered mental status.
   • Chest pain, chest tightness
   • Dyspnea, shortness of breath
   • Fever
6. Diagnosed as terminally ill by a health professional, defined as life expectancy of 6 months or less.
7. Pregnant or intend to be pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCALE-NCD (Intervention); Intervention arm will receive the following two components of the SCALE-NCD intervention package: FCHV home visits every three months, including measurements, counseling and referral;; Mobile phone messages, including lifestyle modification	Behavioral: SCALE-NCD; FCHV home visits every three months, includingFor hypertension i. Blood pressure measurement with digital BP devices ii. Lifestyle counseling iii. Referral if uncontrolled BP (≥140/90 mmHg) for 3 monthsFor 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 monthsFor current smokers i. Smoking cessation counseling ii. Referral for nicotine replacement therapy if request by participants; Mobile phone messages, includingLifestyle modificationConveyed as voice or text messages, depending on participant preference
No Intervention: Control; Control arm will receive the usual care in Pokhara Metropolitan City in Nepal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure (mmHg)	Difference in systolic blood pressure change between the intervention and the control groups among participants enrolled as having hypertension.	6 months post randomization
Fasting Plasma glucose	Difference in fasting plasma glucose change between the intervention and the control groups among participants enrolled as having type 2 diabetes.	6 months post randomization
Participants Who Have Achieved Smoking cessation	Participants who have not smoked for the past 30 days between the intervention and the control groups, among participants enrolled as current smokers.	6 months post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diastolic blood pressure (mmHg)	Difference in diastolic blood pressure change between the intervention and the control groups among participants enrolled as having hypertension.	6 months post randomization
Controlled blood pressure control (<140/90 mmHg) rate	Difference in the proportion of those with BP<140/90 mmHg between the intervention and the control groups, among participants enrolled as having hypertension.	6 months post randomization
Mean HbA1c level	Difference in mean HbA1c between the intervention and the control groups, among participants enrolled as having type 2 diabetes.	6 months post randomization
Mean Weight in Kg	Difference in mean weight between the intervention and the control groups, among participants enrolled as having type 2 diabetes.	6 months post randomization
Mean Total Cholesterol (mg/dL)	Difference in mean total cholesterol levels between the intervention and the control groups, among participants with high total cholesterol (≥ 200 mg/dL) at baseline.	6 months post randomization
Mean HDL (mg/dL)	Difference in mean HDL levels between the intervention and the control groups, among participants with low HDL (< 40 mg/dL) at baseline.	6 months post randomization
Mean LDL level (mg/dL)	Difference in mean LDL levels between the intervention and the control groups, among participants with high LDL (≥ 100 mg/dL) at baseline.	6 months post randomization
Mean Triglyceride Levels (mg/dL)	Difference in mean triglyceride levels between the intervention and the control groups, among participants with high triglyceride level (≥ 150 mg/dL) at baseline.	6 months post randomization
Medication adherence, antihypertensive medicines	Difference in the proportion of those not missing a single anti-hypertensive pill over the past 1 week between the intervention and the control groups, among participants enrolled as having hypertension.	6 months post randomization
Medication adherence, hypoglycemic medicines	Difference in the proportion of those not missing a single hypoglycemic pill or injection over the past 1 week between the intervention and the control groups, among participants enrolled as having type 2 diabetes.	6 months post randomization
Fagerstrom Test for Nicotine Dependence (FTND) score	Difference in the proportion of those with a high FTND score (5-10) between the intervention and the control groups, among participants enrolled as current smokers. Higher means more dependence on nicotine.	6 months post randomization
Smoking cessation, 7 days	Difference in the proportion of those who have not smoked for the past 7 days between the intervention and the control groups, among participants enrolled as current smokers.	6 months post randomization
Harmful alcohol consumption rate, self-report	Difference in the proportion of those taking 7 (if women) and 14 (if men) standard drinks over the past 1 week between the intervention and the control groups, among all participants.	6 months post randomization
Low dietary salt intake rate, self-report	Difference in the proportion of those taking 5 mg or less salt per day between the intervention and the control groups, among participants enrolled as having hypertension.	6 months post randomization
High physical activity rate, self-report	Difference in the proportion of those who had 3000 metabolic equivalents of tasks (MET) or more per week between the intervention and control groups, among participants enrolled as having hypertension and/or diabetes.	6 months post randomization
High fruit and vegetable intake rate, self-report	Difference in the proportion of those who consumed 5 or more servings of fruits and/or vegetables per day between the intervention and control groups, among participants enrolled as having hypertension and/or diabetes.	6 months post randomization

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Dinesh Neupane, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): December 18, 2024

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: hypertension; type 2 diabetes mellitus; community health workers; tobacco smoking; task-shifting; task-sharing; female community health volunteers
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Behavior; Nutritional and Metabolic Diseases; Smoking; Tobacco Use; Hypertension; Diabetes Mellitus, Type 2; Tobacco Smoking
• Other Study ID Numbers: IRB00030203; R01HL172271 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No