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Basic and translational research
Protocol
Worksite intervention study to prevent diabetes in Nepal: a randomised trial protocol
  1. Prajjwal Pyakurel1,
  2. Archana Shrestha2,
  3. Biraj M Karmacharya2,
  4. Shyam S Budhathoki3,
  5. Rajendra Kumar Chaudhari1,
  6. Dipesh Tamrakar2,
  7. Abha Shrestha2,
  8. Robin M Karmacharya2,
  9. Anmol Shrestha2,
  10. Sumitra Sharma4,
  11. Sanjib Kumar Sharma1 and
  12. Donna Spiegelman5
  1. 1B.P. Koirala Institute of Health Sciences, Dharan, Nepal
  2. 2Kathmandu University School of Medical Sciences, Kathmandu, Nepal
  3. 3Golden Community Hospital, Lalitpur, Nepal
  4. 4Kathmadnu Medical College Teaching Hospital, Kathmandu, Nepal
  5. 5Yale School of Public Health, New Haven, Connecticut, USA
  1. Correspondence to Dr Prajjwal Pyakurel; prazzwal{at}gmail.com

Abstract

Introduction In Nepal, approximately 31% of adult industrial employees have diabetes. While the prevention of type 2 diabetes through behavioural intervention has been disseminated, worksite could be an effective platform for the translation of this knowledge into action as employed adults spend most of their workday waking hours at workplaces.

Methods and analysis We will conduct a randomised controlled trial to assess the effectiveness of a behavioural and a canteen intervention on diabetes risk reduction among those who are prediabetic at two worksites in eastern Nepal. We will recruit 162 adult full-time factory workers with haemoglobin A1c (HbA1c) of 5.7%–6.4% at baseline or fasting blood sugar of 100–125 mg/dL. The 8–14 months’ control period will be followed by the behavioural intervention where half of the participants will be randomised to receive the behavioural intervention and half will act as a control and will not receive any intervention. Then, all participants will receive the canteen intervention. The analysis will be intent-to-treat, comparing the difference in the change in HbA1c% between the behavioural intervention group and the control group using a two-sample t-test. The within-participant changes in HbA1c after 6 or more months on the canteen intervention among those not randomised to the behavioural intervention in the previous period will be assessed using the paired t-test.

Ethics and dissemination Ethical approval was obtained from the Institutional Review Board at Yale School of Public Health, New Havens, USA and the Nepal Health Research Council.

Trial registration number NCT04161937.

  • coronary artery disease
  • diabetic heart disease
  • public health
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/openhrt-2019-001236

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    Footnotes

    • Twitter @sanjibks1969

    • Contributors PP, ArS, SKS, BMK and DS contributed substantially to the conception and design of this project. PP, SSB and DT contributed to refining the data collection tools. RKC contributed to the design of the laboratory procedures. AbS, PP and ArS contributed to the formative study. DS, ArS contributed to designing the statistical framework. RMK, AnS and SS refined the manuscript in the initial stage. All authors contributed to final refining and approval of the manuscript.

    • Funding This study was funded by NIH Director’s Pioneer Award (award no: 5DP1ES02545903) and the Bernard Lown Scholar in Cardiovascular Health Program (award no: BLSCHP-1603).

    • Competing interests None declared.

    • Patient consent for publication Obtained.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available upon reasonable request. Data will be available on reasonable request.