Worksite intervention study to prevent diabetes in Nepal: a randomised trial protocol.
Adult
Biomarkers
/ blood
Blood Glucose
/ metabolism
Diabetes Mellitus
/ blood
Glycated Hemoglobin
/ metabolism
Health Behavior
Health Knowledge, Attitudes, Practice
Healthy Lifestyle
Humans
Male
Middle Aged
Multicenter Studies as Topic
Nepal
/ epidemiology
Occupational Health Services
Patient Education as Topic
Prediabetic State
/ blood
Primary Prevention
Randomized Controlled Trials as Topic
Risk Reduction Behavior
Time Factors
Treatment Outcome
coronary artery disease
diabetic heart disease
public health
Journal
Open heart
ISSN: 2053-3624
Titre abrégé: Open Heart
Pays: England
ID NLM: 101631219
Informations de publication
Date de publication:
08 2020
08 2020
Historique:
received:
01
01
2020
revised:
03
07
2020
accepted:
06
07
2020
entrez:
28
8
2020
pubmed:
28
8
2020
medline:
22
12
2020
Statut:
ppublish
Résumé
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. 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. Ethical approval was obtained from the Institutional Review Board at Yale School of Public Health, New Havens, USA and the Nepal Health Research Council. NCT04161937.
Identifiants
pubmed: 32847993
pii: openhrt-2019-001236
doi: 10.1136/openhrt-2019-001236
pmc: PMC7451278
pii:
doi:
Substances chimiques
Biomarkers
0
Blood Glucose
0
Glycated Hemoglobin A
0
hemoglobin A1c protein, human
0
Banques de données
ClinicalTrials.gov
['NCT04161937']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : NIEHS NIH HHS
ID : DP1 ES025459
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001863
Pays : United States
Informations de copyright
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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