Work-Site Intervention Study to Prevent Diabetes in Nepal
Atslēgvārdi
Abstrakts
Apraksts
Diabetes is the fifth leading cause of death in the most high-income countries and there is substantial evidence that it is epidemic in many low- and middle-income countries. Complications from diabetes, such as coronary artery and peripheral vascular disease, stroke, diabetic neuropathy, amputations, renal failure and blindness results in disability, reduced life expectancy and enormous health costs.The global age standardized prevalence of diabetes has nearly doubled since 1980, rising from 4.7% to 8.5% in the adult population.In Nepal, there is a lack of reliable and representative data on the prevalence of type 2 diabetes.Various small studies from different parts of the country have shown prevalence rates ranging from 6.3% to 8.5%.The burden of diabetes in terms of disability adjusted life years has increased almost 100% from 1990 to 2010. A pilot study in an industrial setting showed a prevalence of 4% diabetes and 31% pre-diabetes among adult employees.The prevention of type 2 diabetes through lifestyle intervention has been established by several clinical trials.These studies had a strong focus on increased physical activity and dietary modification as well as weight reduction among overweight participants. The US Diabetes Prevention Program clinical trial demonstrated that structured lifestyle interventions—such as training people with pre-diabetes to achieve modest weight loss through diet and physical activity—reduced three-year diabetes incidence by 58 percent. Studies have shown that simple modifications to the physical environment can be important in increasing physical activity and altering dietary habits. However, the translation of the knowledge to the real world setting is a challenge. Strategies to translate the preventive measures by innovative and culturally specific environmental and individual level intervention are lacking.
Work-site could be an effective platform to translate this knowledge into action as employed adults spend most of their workday waking hours at workplaces.Workplaces have additional advantages because of convenience to reach people; social support; existing formal and informal communication networks; and possible corporate behavior network.Studies have shown positive impact of diabetes prevention at work-site and other settings.Additionally,environmental changes to the work-sites can achieve modest improvement in employees' health risks, including weight and body mass index ( BMI) measures, in one year and reduced glycated hemoglobin(HbA1c) among pre-diabetic adult employee. In 2013, investigators conducted a survey of cardiovascular disease risk factors among employees of a wire industry in the eastern Nepal. The study showed that about a third of the employees were pre-diabetic and 4% had diabetes. Investigators established an ongoing work-site screening and preventive cardiovascular disease care program in the wire industry in January 2016. Furthermore, investigators conducted a qualitative study to understand willingness, facilitators and barriers to promote healthy diet in the industry cafeteria (unpublished). Building on these ground works, investigators propose implementing and evaluating the effectiveness of a work-site based lifestyle modification - an environmental modification in cafeterias and a lifestyle change education package.Investigators propose a pre-post trial with a control period to assess the effectiveness of the individual level lifestyle intervention on diabetes risk reduction among pre-diabetic (HbA1c of 5.7 to 6.4%) employees of two industries in Nepal.Investigators will provide lifestyle education to half of the randomly selected participants after 6 to 14 months of control period. Additionally, cafeteria intervention will be provided to all the pre-diabetic participants. The study aims to:
Aim 1: To measure the effectiveness of an environmental-level cafeteria intervention on diabetes risk.
Aim 2: To measure the effectiveness of an individual-level lifestyle education on the risk of diabetes prevention.
If the program is shown to be effective at these work-sites, the results of this study will be used to recommend and disseminate a sustainable environment and lifestyle interventions at work-sites to improve the health of workers, other Nepali work-sites, and to Nepal's national program for prevention and control of non- communicable disease. Furthermore, lessons from this study can be used to make recommendations or plan studies of similar work-site programs in the U.S. and other settings outside of Nepal.
Datumi
Pēdējoreiz pārbaudīts: | 10/31/2019 |
Pirmais iesniegtais: | 11/09/2019 |
Paredzētā reģistrācija iesniegta: | 11/09/2019 |
Pirmais izlikts: | 11/12/2019 |
Pēdējais atjauninājums iesniegts: | 11/13/2019 |
Pēdējā atjaunināšana ievietota: | 11/17/2019 |
Faktiskais studiju sākuma datums: | 12/31/2017 |
Paredzamais primārās pabeigšanas datums: | 08/31/2020 |
Paredzamais pētījuma pabeigšanas datums: | 02/27/2021 |
Stāvoklis vai slimība
Iejaukšanās / ārstēšana
Behavioral: Behavioural Intervention
Fāze
Roku grupas
Roka | Iejaukšanās / ārstēšana |
---|---|
Experimental: Behavioural Intervention Half of the randomly selected participants will get behavioural intervention based on Diabetes Prevention Program module.The behavioural intervention classed will be administered by trained nurse weekly for 16 weeks.After completion of behavioural intervention both the experimental and control arm will get cafeteria intervention. | |
Experimental: Control Half of the participants will act as a control and will not receive any form of behavioural intervention. |
Atbilstības kritēriji
Vecums, kas piemērots studijām | 18 Years Uz 18 Years |
Dzimumi, kas ir piemēroti studijām | All |
Pieņem veselīgus brīvprātīgos | Jā |
Kritēriji | Inclusion Criteria: 1) Pre-diabetic participants (HbA1c 5.7-6.4%) and FBS (>=100 to 125mg/dl) Exclusion Criteria: 1. Diabetic - HbA1c (>=6.5%) and FBS > 126mg/dl 2. HbA1c <5.7% and FBS <100mg/dl 3. Taking hypertension,diabetes medication 4. Pregnancy 5. Temporary workers 6. Age <18 years |
Rezultāts
Primārie rezultāti
1. HbA1C [24months]