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The Reversal Intervention for Metabolic Syndrome (TRIMS) study: rationale, design, and baseline data.

Dunkley AJ, Davies MJ, Stone MA, Taub NA, Troughton J, Yates T, Khunti K - Trials (2011)

Bottom Line: Recent attention has focused on strategies to combat the forecast epidemic of type-2 diabetes (T2DM) and its major vascular sequelae.Median age was 63 years (IQR 57 - 67), mean waist size 106 cm (SD ± 11), and prescribing of statins and anti-hypertensives was 51% in each case.Information gathered in relation to the programme's acceptability and effectiveness in a multi-ethnic population would ensure that our results are widely applicable.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Health Sciences, University of Leicester, Leicester, UK. ajd38@le.ac.uk

ABSTRACT

Background: Recent attention has focused on strategies to combat the forecast epidemic of type-2 diabetes (T2DM) and its major vascular sequelae. Metabolic syndrome (MetS) comprises a constellation of factors that increase the risk of cardiovascular disease (CVD) and T2DM. Our study aims to develop a structured self-management education programme for people with MetS, which includes management of cardiovascular and diabetes risk factors, and to determine its impact. This paper describes the rationale and design of the TRIMS study, including intervention development, and presents baseline data.

Methods: Subjects recruited from a mixed-ethnic population with MetS were randomised to intervention or control arms. The intervention arm received structured group education based on robust psychological theories and current evidence. The control group received routine care. Follow-up data will be collected at 6 and 12 months. The primary outcome measure will be reversal of metabolic syndrome in the intervention group subjects compared to controls at 12 months follow-up.

Results: 82 participants (44% male, 22% South Asian) were recruited between November 2009 and July 2010. Baseline characteristics were similar for both the intervention (n = 42) and control groups (n = 40). Median age was 63 years (IQR 57 - 67), mean waist size 106 cm (SD ± 11), and prescribing of statins and anti-hypertensives was 51% in each case.

Conclusion: Results will provide information on changes in diabetes and CVD risk factors and help to inform primary prevention strategies in people with MetS from varied ethnic backgrounds who are at high risk of developing T2DM and CVD. Information gathered in relation to the programme's acceptability and effectiveness in a multi-ethnic population would ensure that our results are widely applicable.

Trial registration: The study is registered at ClinicalTrials.gov, study identifier: NCT01043770.

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Related in: MedlinePlus

Flow chart of recruitment and randomisation to TRIMS Study.
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Figure 1: Flow chart of recruitment and randomisation to TRIMS Study.

Mentions: Participants were recruited to the main trial between November 2009 and July 2010 (Figure 1). In total, 322 potentially eligible people were invited to participate from 8 different general practices. Of those people who were invited, 40% (n = 129) volunteered to participate, 16% (n = 52) refused, and 44% (n = 141) did not reply. Reasons given by those who declined to participate (n = 52) included lack of time due to work or other commitments (23%), no perceived need for additional advice or health checks (29%), and other health problems (5%). Overall, 82 people were enrolled onto the study, 42 to the intervention group and 40 to the control.


The Reversal Intervention for Metabolic Syndrome (TRIMS) study: rationale, design, and baseline data.

Dunkley AJ, Davies MJ, Stone MA, Taub NA, Troughton J, Yates T, Khunti K - Trials (2011)

Flow chart of recruitment and randomisation to TRIMS Study.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3113982&req=5

Figure 1: Flow chart of recruitment and randomisation to TRIMS Study.
Mentions: Participants were recruited to the main trial between November 2009 and July 2010 (Figure 1). In total, 322 potentially eligible people were invited to participate from 8 different general practices. Of those people who were invited, 40% (n = 129) volunteered to participate, 16% (n = 52) refused, and 44% (n = 141) did not reply. Reasons given by those who declined to participate (n = 52) included lack of time due to work or other commitments (23%), no perceived need for additional advice or health checks (29%), and other health problems (5%). Overall, 82 people were enrolled onto the study, 42 to the intervention group and 40 to the control.

Bottom Line: Recent attention has focused on strategies to combat the forecast epidemic of type-2 diabetes (T2DM) and its major vascular sequelae.Median age was 63 years (IQR 57 - 67), mean waist size 106 cm (SD ± 11), and prescribing of statins and anti-hypertensives was 51% in each case.Information gathered in relation to the programme's acceptability and effectiveness in a multi-ethnic population would ensure that our results are widely applicable.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Health Sciences, University of Leicester, Leicester, UK. ajd38@le.ac.uk

ABSTRACT

Background: Recent attention has focused on strategies to combat the forecast epidemic of type-2 diabetes (T2DM) and its major vascular sequelae. Metabolic syndrome (MetS) comprises a constellation of factors that increase the risk of cardiovascular disease (CVD) and T2DM. Our study aims to develop a structured self-management education programme for people with MetS, which includes management of cardiovascular and diabetes risk factors, and to determine its impact. This paper describes the rationale and design of the TRIMS study, including intervention development, and presents baseline data.

Methods: Subjects recruited from a mixed-ethnic population with MetS were randomised to intervention or control arms. The intervention arm received structured group education based on robust psychological theories and current evidence. The control group received routine care. Follow-up data will be collected at 6 and 12 months. The primary outcome measure will be reversal of metabolic syndrome in the intervention group subjects compared to controls at 12 months follow-up.

Results: 82 participants (44% male, 22% South Asian) were recruited between November 2009 and July 2010. Baseline characteristics were similar for both the intervention (n = 42) and control groups (n = 40). Median age was 63 years (IQR 57 - 67), mean waist size 106 cm (SD ± 11), and prescribing of statins and anti-hypertensives was 51% in each case.

Conclusion: Results will provide information on changes in diabetes and CVD risk factors and help to inform primary prevention strategies in people with MetS from varied ethnic backgrounds who are at high risk of developing T2DM and CVD. Information gathered in relation to the programme's acceptability and effectiveness in a multi-ethnic population would ensure that our results are widely applicable.

Trial registration: The study is registered at ClinicalTrials.gov, study identifier: NCT01043770.

Show MeSH
Related in: MedlinePlus