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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL172271 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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:
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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCALE-NCD (Intervention) | Experimental | Intervention arm will receive the following two components of the SCALE-NCD intervention package:
|
|
| Control | No Intervention | Control arm will receive the usual care in Pokhara Metropolitan City in Nepal. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCALE-NCD | Behavioral |
|
| 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 |
| 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 |
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Inclusion Criteria:
Meeting at least one of the following three conditions
Registered on the voter list in Pokhara.
Not planning to migrate outside of Pokhara during the study period
Exclusion Criteria:
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:
Diagnosed as terminally ill by a health professional, defined as life expectancy of 6 months or less.
Pregnant or intend to be pregnant
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| Name | Affiliation | Role |
|---|---|---|
| Dinesh Neupane, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pokhara Metropolitan City | Pokhara | Gandaki | Nepal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42400007 | Derived | Inagaki Y, Koirala S, Khan MH, Ghimire K, Soti PB, Bhattarai N, Bhandari P, Pathiravasan CH, Bhandari B, Thapa R, Khadka KB, Yao Z, Shrestha A, Garcia-Larsen V, Finkelstein EA, Moore JB, Closser S, Appel LJ, Kallestrup P, Neupane D. Scaling up community-based non-communicable disease research into practice in Pokhara Metropolitan City of Nepal (SCALE-NCD) trial: study protocol for a cluster-randomized controlled trial. Trials. 2026 Jul 3. doi: 10.1186/s13063-026-09842-w. Online ahead of print. | |
| 42245813 |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003924 | Diabetes Mellitus, Type 2 |
| D000073869 | Tobacco Smoking |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
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|
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 |
| Derived |
| Inagaki Y, Koirala S, Khan MH, Ghimire K, Soti PB, Bhattarai N, Bhandari P, Pathiravasan CH, Bhandari B, Thapa R, Khadka KB, Yao Z, Shrestha A, Garcia-Larsen V, Finkelstein EA, Moore JB, Closser S, Appel LJ, Kallestrup P, Neupane D. Scaling Up Community-based Noncommunicable Disease Research into Practice in Pokhara Metropolitan City of Nepal (SCALE-NCD) trial: study protocol for a cluster-randomized controlled trial. Res Sq [Preprint]. 2026 May 25:rs.3.rs-8320113. doi: 10.21203/rs.3.rs-8320113/v1. |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |