Dataset Information

Let's prevent diabetes: study protocol for a cluster randomised controlled trial of an educational intervention in a multi-ethnic UK population with screen detected impaired glucose regulation.

ABSTRACT: The prevention of type 2 diabetes is a globally recognised health care priority, but there is a lack of rigorous research investigating optimal methods of translating diabetes prevention programmes, based on the promotion of a healthy lifestyle, into routine primary care. The aim of the study is to establish whether a pragmatic structured education programme targeting lifestyle and behaviour change in conjunction with motivational maintenance via the telephone can reduce the incidence of type 2 diabetes in people with impaired glucose regulation (a composite of impaired glucose tolerance and/or impaired fasting glucose) identified through a validated risk score screening programme in primary care.Cluster randomised controlled trial undertaken at the level of primary care practices. Follow-up will be conducted at 12, 24 and 36 months. The primary outcome is the incidence of type 2 diabetes. Secondary outcomes include changes in HbA1c, blood glucose levels, cardiovascular risk, the presence of the Metabolic Syndrome and the cost-effectiveness of the intervention.The study consists of screening and intervention phases within 44 general practices coordinated from a single academic research centre. Those at high risk of impaired glucose regulation or type 2 diabetes are identified using a risk score and invited for screening using a 75 g-oral glucose tolerance test. Those with screen detected impaired glucose regulation will be invited to take part in the trial. Practices will be randomised to standard care or the intensive arm. Participants from intensive arm practices will receive a structured education programme with motivational maintenance via the telephone and annual refresher sessions. The study will run from 2009-2014.This study will provide new evidence surrounding the long-term effectiveness of a diabetes prevention programme conducted within routine primary care in the United Kingdom.Clinicaltrials.gov NCT00677937.

SUBMITTER: Gray LJ

PROVIDER: S-EPMC3431251 | biostudies-literature | 2012 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Let's prevent diabetes: study protocol for a cluster randomised controlled trial of an educational intervention in a multi-ethnic UK population with screen detected impaired glucose regulation.

Gray Laura J LJ Khunti Kamlesh K Williams Sian S Goldby Stephanie S Troughton Jacqui J Yates Thomas T Gray Alastair A Davies Melanie J MJ

Cardiovascular diabetology 20120520

<h4>Background</h4>The prevention of type 2 diabetes is a globally recognised health care priority, but there is a lack of rigorous research investigating optimal methods of translating diabetes prevention programmes, based on the promotion of a healthy lifestyle, into routine primary care. The aim of the study is to establish whether a pragmatic structured education programme targeting lifestyle and behaviour change in conjunction with motivational maintenance via the telephone can reduce the i ...[more]

PMID: 22607160

Similar Datasets

Project description:Prevention of type 2 diabetes mellitus (T2DM) is a global priority. Let's Prevent Diabetes is a group-based diabetes prevention programme; it was evaluated in a cluster-randomised trial, in which the primary analysis showed a reduction in T2DM (hazard ratio [HR] 0.74, 95% CI 0.48-1.14, p = 0.18). We examined the association of engagement and retention with the Let's Prevent Diabetes prevention programme and T2DM incidence.We used data from a completed cluster-randomised controlled trial including 43 general practices randomised to receive either standard care or a 6-h group structured education programme with an annual refresher course for 2 y. The primary outcome was progression to T2DM at 3 y. The characteristics of those who attended the initial education session (engagers) versus nonengagers and those who attended all sessions (retainers) versus nonretainers were compared. Risk reduction of progression to T2DM by level of attendance was compared to standard care. Eight hundred and eighty participants were recruited, with 447 to the intervention arm, of which 346 (77.4%) were engagers and 130 (29.1%) were retainers. Retainers and engagers were more likely to be older, leaner, and nonsmokers than nonretainers/nonengagers. Engagers were also more likely to be male and be from less socioeconomically deprived areas than nonengagers. Participants who attended the initial session and at least one refresher session were less likely to develop T2DM compared to those in the control arm (30 people of 248 versus 67 people of 433, HR 0.38 [95% CI 0.24-0.62]). Participants who were retained in the programme were also less likely to develop T2DM compared to those in the control arm (7 people of 130 versus 67 people of 433, HR 0.12 [95% CI 0.05-0.28]). Being retained in the programme was also associated with improvements in glucose, glycated haemoglobin (HbA1c), weight, waist circumference, anxiety, quality of life, and daily step count. Given that the data used are from a clinical trial, those taking part might reflect a more motivated sample than the population, which should be taken into account when interpreting the results.This study suggests that being retained/engaged in a relatively low-resource, pragmatic diabetes prevention programme for those at high risk is associated with reductions in the progression to T2DM in comparison to those who receive standard care. Nonengagers and nonretainers share similar high-risk traits. Service providers of programmes should focus on reaching these hard-to-reach groups.ClinicalTrials.gov ISRCTN80605705.

Project description:ImportanceThe nationwide fecal immunochemical test-based screening program has influenced surgical care for patients with colorectal cancer (CRC) in the Netherlands, although these implications have not been studied in much detail so far.ObjectiveTo compare surgical outcomes of patients diagnosed as having CRC through the fecal immunochemical test-based screening program (screen detected) and patients with non-screen-detected CRC.Design, setting, and participantsThis was a population-based comparative cohort study using the Dutch ColoRectal Audit and analyzed all Dutch hospitals performing CRC resections. Patients who underwent elective resection for CRC between January 2011 to December 2016 were included.InterventionsColorectal cancer surgery.Main outcomes and measuresPostoperative nonsurgical complications, postoperative surgical complications, postoperative 30-day or in-hospital mortality, and complicated course (postoperative complication resulting in a hospital stay >14 days and/or a reintervention and/or mortality). A risk-stratified comparison was made for different postoperative outcomes based on screening status (screen detected vs not screen detected), cancer stage (I-IV), and for cancer stage I to III also on age (aged ≤70 years and >70 years) and American Society of Anesthesiologists score (I-II and III-IV). To determine any residual case-mix-corrected differences in outcomes between patients with screen-detected and non-screen-detected cancer, univariable and multivariable logistic regression analyses were performed.ResultsIn total, 36 242 patients with colon cancer and 17 416 patients with rectal cancer were included for analysis. Compared with patients with non-screen-detected CRC, screen-detected patients were younger (mean [SD] age, 68 [5] vs 70 [11] years), more often men (3777 [60%] vs 13 506 [57%]), and had lower American Society of Anesthesiologists score (American Society of Anesthesiologists score III+: 838 [13%] vs 5529 [23%]). Patients with stage I to III colon cancer who were screen detected had a significantly lower mortality and complicated course rate compared with non-screen-detected patients. For patients with rectal cancer, only a significant difference was found in mortality rate in patients with a cancer stage IV disease, which was higher in the screen-detected group. Compared with non-screen-detected colon cancer, an independent association was found for screen-detected colon cancer on nonsurgical complications (adjusted odds ratio, 0.81; 95% CI, 0.73-0.91), surgical complications (adjusted odds ratio, 0.80; 95% CI, 0.72-0.89), and complicated course (adjusted odds ratio, 0.80; 95% CI, 0.71-0.90). Screen-detected rectal cancer had significantly higher odds on mortality.Conclusions and relevancePostoperative outcomes were significantly better for patients with colon cancer referred through the fecal immunochemical test-based screening program compared with non-screen-detected patients. These differences were not found in patients with rectal cancer. The outcomes of patients with screen-detected colon cancer were still better after an extensive case-mix correction, implying additional underlying factors favoring patients referred for surgery through the screening program.

Dataset Information

Let's prevent diabetes: study protocol for a cluster randomised controlled trial of an educational intervention in a multi-ethnic UK population with screen detected impaired glucose regulation.

Publications

Let's prevent diabetes: study protocol for a cluster randomised controlled trial of an educational intervention in a multi-ethnic UK population with screen detected impaired glucose regulation.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets