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

NCT06740708 | Recruiting DMC

• 2 other identifiers: IRB00030203R01HL172271
• Study Type: interventional
• Target: 2,070
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (16)

• Diastolic blood pressure (mmHg)

  6 months post randomization

• Controlled blood pressure control (<140/90 mmHg) rate

  6 months post randomization

• Mean HbA1c level

  6 months post randomization

• Mean Weight in Kg

  6 months post randomization

• Mean Total Cholesterol (mg/dL)

  6 months post randomization

Study Arms (2)

SCALE-NCD (Intervention)

EXPERIMENTAL

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

Behavioral: SCALE-NCD

Control

NO INTERVENTION

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

Interventions

SCALE-NCD 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

SCALE-NCD (Intervention)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Registered on the voter list in Pokhara.
• Not planning to migrate outside of Pokhara during the study period

You may not qualify if:

• Blood pressure ≥180/120 mmHg or
• Blood glucose \>250 mg/dL or \<54 mg/dL
• Diagnosed with secondary hypertension by health professionals
• Diagnosed with other diabetes besides type 2 by health professionals
• 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
• Diagnosed as terminally ill by a health professional, defined as life expectancy of 6 months or less.
• Pregnant or intend to be pregnant

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Johns Hopkins Bloomberg School of Public Health: lead

Study Sites (1)

Pokhara Metropolitan City

Pokhara, Gandaki, Nepal

RECRUITING

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2; Tobacco Smoking

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Smoking; Behavior; Tobacco Use

Study Officials

• Dinesh Neupane, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dinesh Neupane, PhD

CONTACT

410-502-9170; dneupan2@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: April 28, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): February 28, 2029
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)