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

NCT ID: NCT06740708

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2070 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-28
• Study Completion Date: 2029-02-28

Brief 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.

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.

Conditions

Hypertension; Type 2 Diabetes Mellitus (T2DM); Tobacco Smoking

Keywords

hypertension; type 2 diabetes mellitus; tobacco smoking; task-sharing; task-shifting; community health workers; female community health volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

SCALE-NCD (Intervention)

Intervention arm will receive the following two components of the SCALE-NCD intervention package:

1. FCHV home visits every three months, including measurements, counseling and referral;

2. Mobile phone messages, including lifestyle modification

Group Type: EXPERIMENTAL

SCALE-NCD

Intervention Type: BEHAVIORAL

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

Control

Control arm will receive the usual care in Pokhara Metropolitan City in Nepal.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SCALE-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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dinesh Neupane, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Pokhara Metropolitan City

Pokhara, Gandaki, Nepal

Site Status: RECRUITING

Countries

Nepal

Central Contacts

Dinesh Neupane, PhD

Role: CONTACT

Phone: 410-502-9170

Email: dneupan2@jhu.edu

Facility Contacts

Sweta Koirala, PhD

Role: primary

Other Identifiers

R01HL172271

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00030203

Identifier Type: -

Identifier Source: org_study_id