Dataset Information

Effects of the Norfolk diabetes prevention lifestyle intervention (NDPS) on glycaemic control in screen-detected type 2 diabetes: a randomised controlled trial.

ABSTRACT:

Background

The purpose of this trial was to test if the Norfolk Diabetes Prevention Study (NDPS) lifestyle intervention, recently shown to reduce the incidence of type 2 diabetes in high-risk groups, also improved glycaemic control in people with newly diagnosed screen-detected type 2 diabetes.

Methods

We screened 12,778 participants at high risk of type 2 diabetes using a fasting plasma glucose and glycosylated haemoglobin (HbA1c). People with screen-detected type 2 diabetes were randomised in a parallel, three-arm, controlled trial with up to 46 months of follow-up, with a control arm (CON), a group-based lifestyle intervention of 6 core and up to 15 maintenance sessions (INT), or the same intervention with additional support from volunteers with type 2 diabetes trained to co-deliver the lifestyle intervention (INT-DPM). The pre-specified primary end point was mean HbA1c compared between groups at 12 months.

Results

We randomised 432 participants (CON 149; INT 142; INT-DPM 141) with a mean (SD) age of 63.5 (10.0) years, body mass index (BMI) of 32.4 (6.4) kg/m², and HbA1c of 52.5 (10.2) mmol/mol. The primary outcome of mean HbA1c at 12 months (CON 48.5 (9.1) mmol/mol, INT 46.5 (8.1) mmol/mol, and INT-DPM 45.6 (6.0) mmol/mol) was significantly lower in the INT-DPM arm compared to CON (adjusted difference -2.57 mmol/mol; 95% CI -4.5, -0.6; p = 0.007) but not significantly different between the INT-DPM and INT arms (-0.55 mmol/mol; 95% CI -2.46, 1.35; p = 0.57), or INT vs CON arms (-2.14 mmol/mol; 95% CI -4.33, 0.05; p = 0.07). Subgroup analyses showed the intervention had greater effect in participants < 65 years old (difference in mean HbA1c compared to CON -4.76 mmol/mol; 95% CI -7.75, -1.78 mmol/mol) than in older participants (-0.46 mmol/mol; 95% CI -2.67, 1.75; interaction p = 0.02). This effect was most significant in the INT-DPM arm (-6.01 mmol/mol; 95% CI -9.56, -2.46 age < 65 years old and -0.22 mmol/mol; 95% CI -2.7, 2.25; aged > 65 years old; p = 0.007). The use of oral hypoglycaemic medication was associated with a significantly lower mean HbA1c but only within the INT-DPM arm compared to CON (-7.0 mmol/mol; 95% CI -11.5, -2.5; p = 0.003).

Conclusion

The NDPS lifestyle intervention significantly improved glycaemic control after 12 months in people with screen-detected type 2 diabetes when supported by trained peer mentors with type 2 diabetes, particularly those receiving oral hypoglycaemics and those under 65 years old. The effect size was modest, however, and not sustained at 24 months.

Trial registration

ISRCTN34805606 . Retrospectively registered 14.4.16.

SUBMITTER: Sampson M

PROVIDER: S-EPMC8375190 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:IntroductionDiabetes and obesity pose a significant burden for the U.S. military beneficiary population, creating a great need to provide evidence-based diabetes and obesity prevention services for military personnel, retirees, and their dependents. Despite increasing dissemination of the Diabetes Prevention Program (DPP) lifestyle intervention nationwide, formal evaluation of implementation of this highly successful program is limited in the military setting. The purpose of this study is to prospectively evaluate delivery of a direct adaptation of a 1-year DPP lifestyle intervention at a U.S. Air Force medical facility, Wright-Patterson Medical Center (WPMC), to determine the feasibility of delivery of the program in a group of at-risk active duty military, retirees, and family members, as well as assess effectiveness in improving weight and other risk factors for type 2 diabetes.Materials and methodsA pre/post study design was utilized to evaluate feasibility and effectiveness of the DPP Group Lifestyle Balance (GLB), an up-to-date, 22-session direct adaptation of the DPP curriculum, at WPMC. Participants chose to complete the 1-year program either in coach-led face-to-face groups or via DVD with weekly telephonic coach contact. The study was approved by the University of Pittsburgh and WPMC Institutional Review Boards.ResultsA total of 99 individuals enrolled in the study, with 83 (84%) and 77 (78%) completing 6- and 12-month follow-up assessments, respectively. The mean age of participants at baseline was 57 (range 20-85 years), with 63% being female. The group was comprised of individuals who were non-Hispanic White (73.7%), non-Hispanic Black (18.2%), and other race or Hispanic ethnicity (8.1%). Within this group, there were 10 active duty military, 37 retirees, and 52 family members. The DPP-GLB program was shown to be feasible to implement in this military healthcare setting as demonstrated by the high engagement over the course of the year-long program. Significant improvements were shown in the two main behavioral goals: mean weight (-12.8 lbs, -6.3%, P < .001) and mean physical activity (PA) (+18.9 Met-hrs/wk, P < .001). In addition, significant improvements in other diabetes and cardiovascular risk factors including low-density lipoprotein cholesterol, fasting insulin, diastolic blood pressure, and waist circumference were noted, as well as improvement in health-related quality of life.ConclusionsThese results demonstrate that the DPP-GLB program delivered via face-to-face groups or DVD was feasible and effective in improving weight, PA levels, and diabetes and cardiovascular risk factors in this group of active and retired military personnel and their family members. The program was well received by the program participants as well as the WPMC team. These findings offer a model for provision of the DPP-GLB program throughout the Military Health System.

Project description:BACKGROUND:The management of hyperglycaemia and associated cardiovascular risk factors in patients with type 2 diabetes mellitus (T2DM) may reduce diabetes-related complications. The strategy to broaden the knowledge base of primary care professionals to improve health care has mainly been prompted by the current reality of limited resources and access to specialized care. The main objective of this study is to assess the effectiveness of comprehensive interventions focused on treatment intensification, decrease clinical inertia and reduce possible barriers to treatment adherence in patients with poorly controlled diabetes in a primary care setting. METHODS:This is a two-phase mixed method study, whose aims are the development of complex interventions and the assessment of their effectiveness. The main study outcome is a change in glycated haemoglobin (HbA1c) levels. The INTEGRA study is divided into two phases. Phase 1: A qualitative study with a phenomenological approach using semi-structured interviews with the objective of determining the factors related to the participants and health care professionals that influence the development and implementation of a specific intervention strategy aimed at patients with poor glycaemic control of T2DM in primary care. Phase 2: Exploratory intervention study to be conducted in Primary Health Care Centres in Catalonia (Spain), including 3 specific health care areas. The intervention study has two arms: Intervention Group 1 and 2. Each intervention group will recruit 216 participants (the same as in the control group) between the ages of 30 and 80?years with deficient glycaemic control (HbA1c > 9%). The control group will be established based on a randomized selection from the large SIDIAP (Sistema d'Informació per al desenvolupament de la Investigació en Atenció Primària) database of patients with comparable socio-demographic and clinical characteristics from the three provinces. DISCUSSION:This study is a comprehensive, pragmatic intervention based on glycaemic treatment intensification and the control of other cardiovascular risk factors. It is also aimed at improving treatment adherence and reducing clinical inertia, which could lead to improved glycaemic control and could likewise be feasible for implementation in the actual clinical practice of primary care. TRIAL REGISTRATION:Clinicaltrials.gov . registration number. NCT02663245; January 25, 2016.

Project description:ObjectiveTo evaluate the effectiveness on glycaemic control of a training programme in consultation skills for paediatric diabetes teams.DesignPragmatic cluster randomised controlled trial.Setting26 UK secondary and tertiary care paediatric diabetes services.Participants79 healthcare practitioners (13 teams) trained in the intervention (359 young people with type 1 diabetes aged 4-15 years and their main carers) and 13 teams allocated to the control group (334 children and their main carers).InterventionTalking Diabetes programme, which promotes shared agenda setting and guiding communication style, through flexible menu of consultation strategies to support patient led behaviour change.Main outcome measuresThe primary outcome was glycated haemoglobin (HbA(1c)) level one year after training. Secondary outcomes were clinical measures (hypoglycaemic episodes, body mass index, insulin regimen), general and diabetes specific quality of life, self reported and proxy reported self care and enablement, perceptions of the diabetes team, self reported and carer reported importance of, and confidence in, undertaking diabetes self management measured over one year. Analysis was by intention to treat. An integrated process evaluation included audio recording a sample of 86 routine consultations to assess skills shortly after training (intervention group) and at one year follow-up (intervention and control group). Two key domains of skill assessment were use of the guiding communication style and shared agenda setting.Results660/693 patients (95.2%) provided blood samples at follow-up. Training diabetes care teams had no effect on HbA(1c) levels (intervention effect 0.01, 95% confidence interval -0.02 to 0.04, P=0.5), even after adjusting for age and sex of the participants. At follow-up, trained staff (n=29) were more capable than controls (n=29) in guiding (difference in means 1.14, P<0.001) and agenda setting (difference in proportions 0.45, 95% confidence interval 0.22 to 0.62). Although skills waned over time for the trained practitioners, the reduction was not significant for either guiding (difference in means -0.33, P=0.128) or use of agenda setting (difference in proportions -0.20, -0.42 to 0.05). 390 patients (56%) and 441 carers (64%) completed follow-up questionnaires. Some aspects of diabetes specific quality of life improved in controls: reduced problems with treatment barriers (mean difference -4.6, 95% confidence interval -8.5 to -0.6, P=0.03) and with treatment adherence (-3.1, -6.3 to -0.01, P=0.05). Short term ability to cope with diabetes increased in patients in intervention clinics (10.4, 0.5 to 20.4, P=0.04). Carers in the intervention arm reported greater excitement about clinic visits (1.9, 1.05 to 3.43, P=0.03) and improved continuity of care (0.2, 0.1 to 0.3, P=0.01).ConclusionsImproving glycaemic control in children attending specialist diabetes clinics may not be possible through brief, team-wide training in consultation skills.Trial registrationCurrent Controlled Trials ISRCTN61568050.

Project description:Lifestyle modification is widely recommended to kidney allograft recipients post transplantation due to the cardiometabolic risks associated with immunosuppression including new-onset diabetes, weight gain and cardiovascular events. However, we have no actual evidence that undertaking lifestyle modification protects from any adverse outcomes post transplantation. The aim of this study is to compare whether a more proactive versus passive interventional approach to modify lifestyle is associated with superior outcomes post kidney transplantation.We designed this prospective, single-centre, open-label, randomised controlled study to compare the efficacy of active versus passive lifestyle intervention for kidney allograft recipients early post transplantation. A total of 130 eligible patients, who are stable, nondiabetic and between 3 and 24 months post kidney transplantation, will be recruited. Randomisation is being undertaken by random block permutations into passive (n?=?65, leaflet guidance only) versus active lifestyle modification (n?=?65, supervised intervention) over a 6-month period. Supervised intervention is being facilitated by two dietitians during the 6-month intervention period to provide continuous lifestyle intervention guidance, support and encouragement. Both dietitians are accredited with behavioural intervention skills and will utilise motivational aids to support study recruits randomised to active intervention. The primary outcome is change in abnormal glucose metabolism parameters after 6 months of comparing active versus passive lifestyle intervention. Secondary outcomes include changes in a wide array of cardiometabolic parameters, kidney allograft function and patient-reported outcome measures. Long-term tracking of patients via data linkage to electronic patient records and national registries will facilitate long-term comparison of outcomes after active versus passive lifestyle intervention beyond the 6-month intervention period.This is the first randomised controlled study to investigate the benefits of active versus passive lifestyle intervention in kidney allograft recipients for the prevention of abnormal cardiometabolic outcomes. In addition, this is the first example of utilising behaviour therapy intervention post kidney transplantation to achieve clinically beneficial outcomes, which has potential implications on many spheres of post-transplant care.This study was registered with the Clinical Trials Registry on 27 August 2014 (ClinicalTrials.org Identifier: NCT02233491 ).