NCT03447340: NPWIS

Nepal Pioneer Worksite Intervention Study

Completed NA Last updated 6 October 2023

What this trial tests

NA trial testing Canteen and Behavior intervention in Dietary Modification in 363 participants. Completed in 9 December 2022.

Timeline

9 November 2016

Primary endpoint
30 March 2022

9 December 2022

Quick facts

Lead sponsor	Yale University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	363
Start date	9 November 2016
Primary completion	30 March 2022
Estimated completion	9 December 2022
Sites	1 location across Nepal

Drugs / interventions tested

• Canteen and Behavior intervention
• Canteen Only

Conditions studied

• Dietary Modification — all drugs for Dietary Modification →
• Diabetes — all drugs for Diabetes →
• Hypertension — all drugs for Hypertension →
• Health Behavior — all drugs for Health Behavior →

Sponsor

Yale University

Who can join

18 and older, any sex, with Dietary Modification or Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The proposed project will develop, implement, and test methodology for the design of an acceptable, effective intervention for diabetes prevention in a real-world setting. By determining the effectiveness of the intervention, the study will serve to guide the translation of research into routine public health prevention programs and policy. And, the hands-on experience will directly support the development of expertise, tools and training to advance translational science as a discipline. The study aims to test the effectiveness of an environmental and individual level intervention to prevent diabetes at Dhulikhel Hospital-Kathmandu University Hospital (DH-KUH), Nepal. Specific aims are to measure:

Effectiveness of a canteen intervention on a composite score based upon improvement in 3 cardio-metabolic risk factors (0-3) \[HbA1c decrease ≥0.5%; a systolic blood pressure decrease (SBP) ≥5 mm Hg; and plasma triglycerides decrease ≥10 mg/dl\] Effectiveness of a behavioral intervention on a composite score based upon improvement in 3 cardio-metabolic risk factors (0-3) \[HbA1c decrease ≥0.5%; SBP decrease ≥5 mm Hg; and plasma triglycerides decrease ≥10 mg/dl\] Effectiveness of a canteen intervention on change in HbA1C and healthy food intake after six months of the canteen only (CO) intervention compared to the change over six months during the control period.

Effectiveness of a behavioral intervention on change in Hba1c and healthy food intake after six months of behavioral intervention plus the canteen (CB) intervention compared to the change over six months during CO.

We will recruit 366 adult employees of DH-KUH. At baseline (T1), 6 months (T2), 12 months (T3) and 18 months (T4), we will administer a standard questionnaire to record relevant characteristics of the participants (age, sex, education, income, marital status, and family history of CVD, physical activity, smoking, alcohol intake and diet). We will abstract food consumption data from the administrative database in DH-KUH. Blood samples will be collected and analyzed for HbA1c, fasting glucose, and lipid profile (HDL, LDL, total cholesterol, triglycerides). We will measure height, weight, waist circumference, hip circumference, and blood pressure. After 6 months of control period, the participants will receive the canteen intervention: (a) form and train a canteen improvement team; (b) train canteen staff on healthy cooking; (c) add healthy food and remove unhealthy food; (d) information and communication of canteen changes to employees; (e) monitoring of the interventions. After six months of the canteen intervention, half of the participants will be randomized to receive the behavioral intervention. The behavior intervention will be a combination of intensive education sessions, group counselling, goal setting and monitoring based on the Diabetes Prevention Program (DPP). The primary analysis will use χ\^2test use to compare (a) Proportion of individual with score ≥ 2 during CO intervention to the proportion of individual with score ≥ 2 during the control period; (b) Proportion of individual with score ≥ 2 during CB intervention to the proportion of individual with score ≥ 2 during CO intervention. We will conduct a logistic regression with the proportion of individual with score ≥ 2 as outcome and CO vs CB as exposure at T4. Secondary analysis will use paired t-test to compare (a) the change in healthy food intake and HbA1c during CO to the change in healthy food intake and HbA1C during the control period (b) the change in healthy food intake and HbA1C% during CB to the change in healthy food intake and HbA1C% during CO period. We will conduct linear regression with HbA1c% as the outcome and CO vs CB as the exposure variable at T4. Further analysis will adjust for confounding in time-varying variables and assess effect modification.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Nepal Pioneer Worksite Intervention Study to lower cardio-metabolic risk factors: design and protocol.
   Shrestha A, Tamrakar D, Karmacharya BM, Shrestha A, et al · · 2019 · cited 11× · PMID 30819098 · DOI 10.1186/s12872-019-1025-3
2. Stakeholder engagement in a hypertension and diabetes prevention research program: Description and lessons learned.
   Shrestha A, Tamrakar D, Shrestha B, Karmacharya BM, et al · · 2022 · cited 10× · PMID 36264860 · DOI 10.1371/journal.pone.0276478
3. Effects of a dietary intervention on cardiometabolic risk and food consumption in a workplace.
   Shrestha A, Tamrakar D, Ghinanju B, Shrestha D, et al · · 2024 · cited 2× · PMID 38656951 · DOI 10.1371/journal.pone.0301826