期刊论文详细信息
Wellcome Open Research
Effectiveness and implementation of a lifestyle modification intervention for women with isolated impaired fasting glucose: Study protocol for a hybrid type 2 study in Kerala, India
article
Elezebeth Mathews1  Thirunavukkarasu Sathish2  Anjaly Joseph1  Bhagieshwari Kodapally1  Jissa Vinoda Thulaseedharan3  KM Venkat Narayan4  Brian Oldenburg5  Kavumpurathu Raman Thankappan1 
[1] Department of Public Health and Community Medicine, Central University of Kerala;Population Health Research Institute ,(PHRI), McMaster University;Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology;Emory Global Diabetes Research Center, Emory University;Baker Heart and Diabetes Institute, Baker Heart and Diabetes Institute
关键词: Prediabetes;    Isolated impaired fasting glucose;    Lifestyle modification;    Kerala;    Women;    RCT;   
DOI  :  10.12688/wellcomeopenres.17631.1
学科分类:内科医学
来源: Wellcome
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【 摘 要 】

Background: Isolated impaired fasting glucose (i-IFG) constitutes a major group in the prediabetic spectrum among Indians, and thus it is imperative to identify effective diabetes prevention strategies. This study aims to evaluate the effects of an intensive community-based lifestyle modification program on regression to normoglycemia among women with i-IFG, compared to a control group at 24 months. The study also aims to evaluate the implementation of the intervention, via both process and implementation outcomes.Methods: We will use a hybrid design (Effectiveness-implementation hybrid type 2 trial) to test the effectiveness and implementation of the lifestyle modification intervention. Effectiveness is evaluated using a randomized controlled trial among 950 overweight or obese women, aged 30 to 60 years, with i-IFG on an oral glucose tolerance test in the Indian state of Kerala. The intervention involves an intensive lifestyle modification program through group and individually mentored sessions using behavioural determinants and behavioural change techniques.  The intervention group will receive the intervention for a period of 12 months and the control group will receive general health advice through a health education booklet. Data on behavioural, clinical, and biochemical measures will be collected using standard methods at 12 and 24 months. The primary outcome will be regression to normoglycemia at 24 months, as defined by the American Diabetes Association criteria.Discussion: This study will provide the first evidence on the effects of lifestyle interventions on regression to normoglycemia in people with i-IFG among Indians.

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