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Effectiveness of a self-management intervention with personalised genetic and lifestyle-related risk information on coronary heart disease and diabetes-related risk in type 2 diabetes (CoRDia): study protocol for a randomised controlled trial.

ABSTRACT: Many patients with type 2 diabetes fail to achieve good glycaemic control. Poor control is associated with complications including coronary heart disease (CHD). Effective self-management and engagement in health behaviours can reduce risks of complications. However, patients often struggle to adopt and maintain these behaviours. Self-management interventions have been found to be effective in improving glycaemic control. Recent developments in the field of genetics mean that patients can be given personalised information about genetic- and lifestyle-associated risk of developing CHD. Such information may increase patients' motivation to engage in self-management. The Coronary Risk in Diabetes (CoRDia) trial will compare the effectiveness of a self-management intervention, with and without provision of personalised genetic- and lifestyle-associated risk information, with usual care, on clinical and behavioural outcomes, the cognitive predictors of behaviour, and psychological wellbeing.Participants will be adults aged 25-74 years registered with general practices in the East of England, diagnosed with type 2 diabetes, with no history of heart disease, and with a glycated haemoglobin level of ?6.45% (47 mmol/mol). Consenting participants will be randomised to one of three arms: usual care control, group self-management only, group self-management plus personalised genetic- and lifestyle-associated risk information. The self-management groups will receive four weekly 2-hour group sessions, focusing on knowledge and information sharing, problem solving, goal setting and action planning to promote medication adherence, healthy eating, and physical activity. Primary outcomes are glycaemic control and CHD risk. Clinical data will be collected from GP records, including HbA1c, weight, body mass index, blood pressure, and HDL and total cholesterol. Self-reported health behaviours, including medication adherence, healthy eating and physical activity, and cognitive outcomes will be assessed by questionnaire. Measures will be taken at baseline, 3 months (questionnaire only), 6 months and 12 months post-baseline.This study will determine whether the addition of personalised genetic- and lifestyle-associated CHD risk information to a group self-management intervention improves diabetes control and CHD risk compared with group self-management and usual care. Effectiveness of the combined intervention on health behaviours cognitions theorised to predict them, and psychological outcomes will also be investigated.This study has been registered at ClinicalTrials.gov; registration identifier NCT01891786 , registered 28 June 2013.

SUBMITTER: Davies AK

PROVIDER: S-EPMC4668706 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

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Effectiveness of a self-management intervention with personalised genetic and lifestyle-related risk information on coronary heart disease and diabetes-related risk in type 2 diabetes (CoRDia): study protocol for a randomised controlled trial.

Davies Anna K AK McGale Nadine N Humphries Steve E SE Hirani Shashivadan P SP Beaney Katherine E KE Bappa Dauda A S DA McCabe John G JG Newman Stanton P SP

Trials 20151202

<h4>Background</h4>Many patients with type 2 diabetes fail to achieve good glycaemic control. Poor control is associated with complications including coronary heart disease (CHD). Effective self-management and engagement in health behaviours can reduce risks of complications. However, patients often struggle to adopt and maintain these behaviours. Self-management interventions have been found to be effective in improving glycaemic control. Recent developments in the field of genetics mean that p ...[more]

PMID: 26631181

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Project description:BackgroundNational Health Service Stop Smoking Services (SSSs) offer help to smokers motivated to quit; however, attendance rates are low and recent figures show a downward trend. We aimed to assess the effectiveness of a two-component personalised intervention on attendance at SSSs.MethodsWe did this randomised controlled trial in 18 SSSs in England. Current smokers (aged ≥16 years) were identified from medical records in 99 general practices and invited to participate by their general practitioner. Individuals who gave consent, were motivated to quit, and had not attended the SSS within the past 12 months, were randomly assigned (3:2), via computer-generated randomisation with permuted blocks (block size of five), to receive either an individually tailored risk letter and invitation to attend a no-commitment introductory session run by the local SSS (intervention group) or a standard generic letter advertising the local SSS (control group). Randomisation was stratified by sex. Masking of participants to receipt of a personal letter and invitation to a taster session was not possible. The personal letter was generated by a research assistant, but the remainder of the research team were masked to group allocation. General practitioners, practice staff, and SSS advisers were unaware of their patients' allocation. The primary outcome was attendance at the first session of an SSS course within 6 months from randomisation. We did analysis by intention to treat. This trial is registered with Current Controlled Trials, number ISRCTN 76561916.FindingsRecruitment, collection of baseline data, delivery of the intervention, and follow up of participants took place between Jan 31, 2011, and July 12, 2014. We randomly assigned 4384 smokers to the intervention group (n=2636) or the control group (n=1748); 4383 participants comprised the intention-to-treat population. Attendance at the first session of an SSS course was significantly higher in the intervention group than in the control group (458 [17·4%] vs 158 [9·0%] participants; unadjusted odds ratio 2·12 [95% CI 1·75-2·57]; p<0·0001).InterpretationDelivery of personalised risk information alongside an invitation to an introductory session more than doubled the odds of attending the SSS compared with a standard generic invitation to contact the service. This result suggests that a more proactive approach, combined with an opportunity to experience local services, can reduce patient barriers to receiving treatment and has high potential to increase uptake.FundingNational Institutes of Health Research Health Technology Assessment.

Project description:BackgroundNo real-world randomised controlled trials (RCTs) have explored the effectiveness of lifestyle interventions based on multiple behaviour change theories and using combined digital and group-based face-to-face delivery to improve risk factors for type 2 diabetes (T2D).MethodsWe conducted a one-year, multi-centre, unblinded, pragmatic RCT in primary healthcare using the habit formation, self-determination, and self-regulation theories among 2907 adults aged 18-74 years at increased T2D risk randomised into a digital lifestyle intervention group (DIGI, n = 967), a combined digital and group-based lifestyle intervention group (DIGI+GROUP, n = 971), and a control group receiving usual care (CONTROL, n = 969). We collected data on primary outcomes (diet quality by Healthy Diet Index [HDI], physical activity, body weight, fasting plasma glucose, 2-hour plasma glucose) and secondary outcomes (sedentary time, waist circumference, fasting plasma insulin) using digital questionnaires, clinical examinations, fasting blood tests, and 2-hour oral glucose tolerance tests. Main statistical analyses were performed using linear mixed-effects models adjusted for age, sex, and province. This RCT was registered with ClinicalTrials.gov, NCT03156478.FindingsThe 2907 participants assigned were recruited between March 1st, 2017, and February 28th, 2018. Diet quality improved more (3·2 vs. 1·4 HDI points, p<0·001 for difference between groups, p'<0·001 for group*time interaction) and waist circumference tended to decrease more (-1·8 vs. -1·3 cm, p = 0·028, p' = 0·068) in DIGI+GROUP than in CONTROL. Fasting insulin tended to increase in CONTROL but not in DIGI (1·0 vs. 0·0 mU/L, p = 0·033, p' = 0·054) or in DIGI+GROUP (1·0 vs. 0·5 mU/L, p = 0·042, p' = 0·054). Good adherence to DIGI and DIGI+GROUP (≥median of 501 habits/year in DIGI, ≥5 of all 6 sessions in GROUP) was associated with improved diet quality and good adherence to DIGI with increased physical activity and decreased sedentary time.InterpretationA lifestyle intervention based on multiple behaviour change theories and combined digital and group-based face-to-face delivery improves diet quality and tends to decrease abdominal adiposity and prevent an increase in insulin resistance. Good adherence improves the results of the interventions.FundingStrategic Research Council at Academy of Finland, Academy of Finland, Novo Nordisk Foundation, and Finnish Diabetes Research foundation.

Project description:BackgroundIn the Republic of Ireland (RoI), fluoridation has been effective and efficient for caries prevention at population level, regardless of income status; however, at individual level it still has limitations. This study aimed to compare personalised versus non-personalised text messaging on 'chance of avoiding new cavities' with the Cariogram, a computer-based caries risk assessment (CRA) model, in an economically disadvantaged adult population in the RoI.MethodsThe intervention was via a CRA summary letter plus 24 weekly personalised mobile-phone short text messages (text messages) based on the individual's CRA, compared with a non-personalised approach via a non-personalised letter and a predetermined, fixed set of 24 weekly text messages. The study was designed as a two-arm parallel-group, single-blinded (assessor), randomised controlled study in County Cork, RoI. The primary outcome was a comparison of 'chance of avoiding new cavities' calculated by the Cariogram with clinical examination, interview, CRT® (Ivoclar Vivadent, Liechtenstein) and three-day food diary between the two groups at follow-up. We combined stratified randomisation with blocked randomisation for 171 participants who completed baseline. Of them, 111 completed follow-up and were analysed (56 and 55 from the personalised and non-personalised groups, respectively). Due to protocol violations, both intent-to-treat (ITT) and per-protocol analyses were conducted.ResultsThe ITT analysis did not show a personalised intervention effect on 'chance of avoiding new cavities'. Of the secondary outcome measures, only the stimulated saliva flow factor showed a personalised intervention effect, p = 0.036, OR = 0.3 (95% CI = 0.1, 0.9). The per-protocol analysis with 21 personalised and 33 non-personalised participants within two-message deviations showed no significant effect on 'chance of avoiding new cavities'.ConclusionsThe null hypothesis in regard to the primary outcome for both ITT and per-protocol analyses was not rejected; however, as the minimal clinically important difference was included in the 95% CI for the per-protocol analysis, replication studies will be worth conducting to explore the potential of mobile devices for individual caries risk reduction.Trial registrationUniversity Hospital Medical Information Network Clinical Trials Registry ( UMIN000027253 ) on 10 May 2017. The study was retrospectively registered.

Project description:BackgroundWeb-based lifestyle interventions at the workplace have the potential to promote health and work productivity. However, the sustainability of effects is often small, which could be enhanced by adding face-to-face contacts, so-called 'blended care'. Therefore, this study evaluates the effects of a blended workplace health promotion intervention on health and work outcomes among employees with increased cardiovascular risk.MethodsIn this multicentre cluster-randomised controlled trial (PerfectFit), 491 workers in 18 work units from military, police, and a hospital with increased cardiovascular risk were randomised into two intervention groups. The limited intervention (n = 213; 9 clusters) consisted of a web-based Health Risk Assessment with advice. In the extensive intervention (n = 271; 8 clusters), coaching sessions by occupational health physicians using motivational interviewing were added. One cluster dropped out after randomisation but before any inclusion of subjects. Primary outcome was self-rated health. Secondary outcomes were body weight, body mass index (BMI), work productivity, and health behaviours. Follow-up measurements were collected at 6 and 12 months. Effect sizes were determined in mixed effects models.ResultsAt 12 months, the extensive intervention was not statistically different from the limited intervention for self-rated health (4.3%; 95%CI -5.3-12.8), BMI (- 0.81; 95%CI -1.87-0.26) and body weight (- 2.16; 95%CI -5.49-1.17). The within-group analysis showed that in the extensive intervention group body weight (- 3.1 kg; 95% CI -2.0 to - 4.3) was statistically significantly reduced, whereas body weight remained stable in the limited intervention group (+ 0.2 kg; 95% CI -1.4 to 1.8). In both randomised groups productivity loss and physical activity increased and excessive alcohol use decreased significantly at 12 months.ConclusionsThere were no effects on self-rated health, body weight, and BMI. However, within the group with web-based tailored Health Risk Assessment including personalized advice body weight reduced significantly. Adding motivational coaching is promising to reduce body weight.Trial registrationRetrospectively registered at the Netherlands Trial Registry with number NTR4894 , at Nov 14 2014.

Project description:OBJECTIVES:In South Asian populations, little is known about the effects of intensive interventions to reduce the risk of type 2 diabetes on health behaviour. We examined the effectiveness at 2 years of a culturally targeted lifestyle intervention on diet, physical activity and determinants of behaviour change among South Asians at risk for diabetes. DESIGN:Randomised controlled trial with de facto masking. SETTING:Primary care. PARTICIPANTS:A total of 536 18- to 60-year-old South Asians at risk for diabetes (ie, with impaired glucose tolerance, impaired fasting glucose or relatively high insulin resistance) were randomised to the intervention (n=283) or a control (n=253) group. Data of 314 participants (n=165?intervention, n=149?control) were analysed. INTERVENTIONS:The culturally targeted intervention consisted of individual counselling using motivational interviewing (six to eight sessions in the first 6 months plus three to four booster sessions), a family session, cooking classes and a supervised physical activity programme. The control group received generic lifestyle advice. OUTCOME MEASURES:We compared changes in physical activity, diet and social-cognitive underlying determinants between the two groups at 2-year follow-up with independent-sample t-tests, chi-square tests and Fisher's exact tests. RESULTS:At the 2-year follow-up, participants in the intervention group were more moderately to vigorously active than at baseline, but compared with changes in the control group, the difference was not significant (change min/week 142.9 vs 0.5, p=0.672). Also, no significant difference was found between the two groups in changes on any of the components of the diet or the social-cognitive determinants of diet and physical activity. CONCLUSIONS:The culturally targeted lifestyle intervention led to high drop-out and was not effective in promoting healthy behaviour among South Asians at risk for diabetes. Given the high a priori risk, we recommend to develop new strategies, preferably more acceptable, to promote healthy behaviour. TRIAL REGISTRATION:NTR1499; Results. www.trialregister.nl/trialreg/admin/rctview.asp?TC=1499.

Dataset Information

Effectiveness of a self-management intervention with personalised genetic and lifestyle-related risk information on coronary heart disease and diabetes-related risk in type 2 diabetes (CoRDia): study protocol for a randomised controlled trial.

Publications

Effectiveness of a self-management intervention with personalised genetic and lifestyle-related risk information on coronary heart disease and diabetes-related risk in type 2 diabetes (CoRDia): study protocol for a randomised controlled trial.

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