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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
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 pr...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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F1000 Research Limited
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9971662/ https://www.ncbi.nlm.nih.gov/pubmed/36865369 http://dx.doi.org/10.12688/wellcomeopenres.17631.1 |
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author | Mathews, Elezebeth Sathish, Thirunavukkarasu Joseph, Anjaly Kodapally, Bhagieshwari Thulaseedharan, Jissa Vinoda Narayan, KM Venkat Oldenburg, Brian Thankappan, Kavumpurathu Raman |
author_facet | Mathews, Elezebeth Sathish, Thirunavukkarasu Joseph, Anjaly Kodapally, Bhagieshwari Thulaseedharan, Jissa Vinoda Narayan, KM Venkat Oldenburg, Brian Thankappan, Kavumpurathu Raman |
author_sort | Mathews, Elezebeth |
collection | PubMed |
description | 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. CTRI registration: CTRI/2021/07/035289 (30/07/2021) |
format | Online Article Text |
id | pubmed-9971662 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | F1000 Research Limited |
record_format | MEDLINE/PubMed |
spelling | pubmed-99716622023-03-01 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 Mathews, Elezebeth Sathish, Thirunavukkarasu Joseph, Anjaly Kodapally, Bhagieshwari Thulaseedharan, Jissa Vinoda Narayan, KM Venkat Oldenburg, Brian Thankappan, Kavumpurathu Raman Wellcome Open Res Study Protocol 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. CTRI registration: CTRI/2021/07/035289 (30/07/2021) F1000 Research Limited 2022-02-15 /pmc/articles/PMC9971662/ /pubmed/36865369 http://dx.doi.org/10.12688/wellcomeopenres.17631.1 Text en Copyright: © 2022 Mathews E et al. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Study Protocol Mathews, Elezebeth Sathish, Thirunavukkarasu Joseph, Anjaly Kodapally, Bhagieshwari Thulaseedharan, Jissa Vinoda Narayan, KM Venkat Oldenburg, Brian Thankappan, Kavumpurathu Raman 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9971662/ https://www.ncbi.nlm.nih.gov/pubmed/36865369 http://dx.doi.org/10.12688/wellcomeopenres.17631.1 |
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