Nepal Pioneer Worksite Intervention Study

NCT03447340 | Completed

• 2 other identifiers: 20000271327DP1ES025459-05
• Study Type: interventional
• Target: 363
• Locations: 1 country
• Sites: 1

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.

Conditions

Dietary Modification; Diabetes; Hypertension; Health Behavior

Outcome Measures

Primary Outcomes (2)

• Cardiometabolic Risks

  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

  Six months

• Healthy food intake

  Intake of whole grains, fruits and vegetables and other healthy labelled items in the canteen from sales data

  six months

Secondary Outcomes (3)

• Hba1c

  six months

• Systolic Blood pressure

  six months

• Diastolic Blood pressure

  six months

Study Arms (2)

Cafeteria and behavior

EXPERIMENTAL

Receives cafeteria intervention and behavior intervention

Behavioral: Canteen and Behavior intervention

Cafeteria only

ACTIVE COMPARATOR

Receives only cafeteria intervention

Other: Canteen Only

Interventions

Canteen and Behavior intervention BEHAVIORAL

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

Cafeteria and behavior

Canteen Only OTHER

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.

Cafeteria only

Eligibility Criteria

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

You may qualify if:

• Full time employees of DH-KUH
• 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 Fastening Blood Sugar (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

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead
• Harvard School of Public Health (HSPH): collaborator
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

Dhulikhel Hospital

Dhulikhel, Nepal

Location

Related Publications (2)

• Shrestha A, Tamrakar D, Ghinanju B, Shrestha D, Khadka P, Adhikari B, Shrestha J, Waiwa S, Pyakurel P, Bhandari N, Karmacharya BM, Shrestha A, Shrestha R, Bhatta RD, Malik V, Mattei J, Spiegelman D. Effects of a dietary intervention on cardiometabolic risk and food consumption in a workplace. PLoS One. 2024 Apr 24;19(4):e0301826. doi: 10.1371/journal.pone.0301826. eCollection 2024.

  PMID: 38656951 DERIVED

• Shrestha A, Tamrakar D, Karmacharya BM, Shrestha A, Shrestha R, Bhatta RD, Pyakurel P, Khudyakov P, Malik V, Mattei J, Spiegelman D. Nepal Pioneer Worksite Intervention Study to lower cardio-metabolic risk factors: design and protocol. BMC Cardiovasc Disord. 2019 Feb 28;19(1):48. doi: 10.1186/s12872-019-1025-3.

  PMID: 30819098 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Health Behavior

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Design

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

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: February 27, 2018
• Study Start: November 9, 2016
• Primary Completion: March 30, 2022
• Study Completion: December 9, 2022
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)