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Nepal Pioneer Worksite Intervention Study (NPWIS)

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ClinicalTrials.gov Identifier: NCT03447340
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Archana Shrestha, Harvard School of Public Health

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Dietary Modification Diabetes Hypertension Health Behavior Behavioral: Canteen and Behavior intervention Other: Canteen Only Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 363 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Nepal Pioneer Work-site Intervention Study
Actual Study Start Date : November 9, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cafeteria and behavior
Receives cafeteria intervention and behavior intervention
Behavioral: Canteen and Behavior intervention

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.

Behavioral : 16 core classes and 8 maintenance classes


Active Comparator: Cafeteria only
Receives only cafeteria intervention
Other: Canteen Only
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.




Primary Outcome Measures :
  1. Cardiometabolic Risks [ Time Frame: Six months ]
    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

  2. Healthy food intake [ Time Frame: six months ]
    Intake of whole grains, fruits and vegetables and other healthy labelled items in the canteen from sales data


Secondary Outcome Measures :
  1. Hba1c [ Time Frame: six months ]
    Glycated haemoglobin, % continuous variable

  2. Systolic Blood pressure [ Time Frame: six months ]
    An average of three measurements, mmHg continuous variable

  3. Diastolic Blood pressure [ Time Frame: six months ]
    An average of three measurements, mmHg continuous variable



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Full time employees of DH-KUH
  • 18 years or above of age
  • Score 30 or more on Indian Diabetes risk score, No confirmation of diabetes and, not on diabetes medication. OR Have HbA1c of 5.7% to 6.4%. OR Prediabetes group with FBS of 100- 126 mg/dL
  • Systolic blood pressure 120 mm Hg or more or Diastolic blood pressure 80 mm Hg or more and not on blood pressure medication

Exclusion Criteria:

  • Less than 18 years
  • On diabetes medication
  • On hypertension medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447340


Locations
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Nepal
Dhulikhel Hospital Recruiting
Dhulikhel, Nepal
Contact: Dipesh Tamrakar, MD    9779801002404    bob.dipesh@gmail.com   
Contact: Biraj M Karmacharya, PhD, MD    9779808660568    birajmk@gmail.com   
Sponsors and Collaborators
Harvard School of Public Health
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Archana Shrestha, Postdoctoral Fellow, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT03447340    
Other Study ID Numbers: IRB16-0301
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases