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Protocol for a randomised controlled trial to evaluate the effectiveness of the diabetes community exercise and education programme (DCEP) for long-term management of diabetes.

ABSTRACT: INTRODUCTION:Type 2 diabetes is common in Māori and Pacific peoples and in those living in areas of high socioeconomic deprivation in New Zealand (NZ). People with type 2 diabetes often have multimorbidity, which makes their diabetes management more complex. The Diabetes Community Exercise and Education Programme (DCEP) is an interprofessional, patient-centred, whānau (family)-supported package of care specifically developed to engage with Māori and Pacific people and those living in deprived areas. We have previously demonstrated the feasibility and acceptability of the DCEP. This study aims to determine the effectiveness and cost-effectiveness of the DCEP through a pragmatic randomised controlled trial (RCT). METHODS AND ANALYSIS:220 adults (age ≥35 years) with type 2 diabetes will be recruited from general practices in the lower South Island of NZ (Dunedin and Invercargill) to participate in an RCT. Participants will be randomised to intervention (DCEP) and control (usual care) groups. The DCEP participants will have their exercise goals agreed on with a physiotherapist and nurse and will attend two 90 min exercise and education sessions per week for 12 weeks. The primary outcome measure is blood glucose control (glycated haemoglobin). Secondary outcome measures include quality of life assessed using the Audit of Diabetes-Dependent Quality of Life questionnaire. Data will be collected at four time points: baseline, end of the 12-week intervention (3 months), 6 months postintervention (9 months) and 12 months after the intervention ends (15 months). We will also conduct a cost-effectiveness analysis and a qualitative process evaluation. ETHICS AND DISSEMINATION:The study has been approved by the Health and Disability Ethics Committee, Ministry of Health (HDEC17/CEN/241/AM01). A key output will be the development of an evidence-based training package to facilitate implementation of the DCEP in other NZ regions. TRIAL REGISTRATION NUMBER:ACTRN 12617001624370 p; Pre-results.

SUBMITTER: Hale L

PROVIDER: S-EPMC6398784 | biostudies-other | 2019 Feb

REPOSITORIES: biostudies-other

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Protocol for a randomised controlled trial to evaluate the effectiveness of the diabetes community exercise and education programme (DCEP) for long-term management of diabetes.

Hale Leigh L Stokes Tim T Scarth Bonnie B Mani Ramakrishnan R Sullivan Trudy T Doolan-Noble Fiona F Jayakaran Prasath P Gray Andrew R AR Mann Jim J Higgs Christopher C

BMJ open 20190221 2

<h4>Introduction</h4>Type 2 diabetes is common in Māori and Pacific peoples and in those living in areas of high socioeconomic deprivation in New Zealand (NZ). People with type 2 diabetes often have multimorbidity, which makes their diabetes management more complex. The Diabetes Community Exercise and Education Programme (DCEP) is an interprofessional, patient-centred, whānau (family)-supported package of care specifically developed to engage with Māori and Pacific people and those living in dep ...[more]

PMID: 30796127

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Project description:IntroductionPeople with type 2 diabetes (T2D) can improve glycaemic control or even achieve remission through weight loss and reduce their use of medication and risk of cardiovascular disease. The Glucose Lowering through Weight management (GLoW) trial will evaluate whether a tailored diabetes education and behavioural weight management programme (DEW) is more effective and cost-effective than a diabetes education (DE) programme in helping people with overweight or obesity and a recent diagnosis of T2D to lower their blood glucose, lose weight and improve other markers of cardiovascular risk.Methods and analysisThis study is a pragmatic, randomised, single-blind, parallel group, two-arm, superiority trial. We will recruit 576 adults with body mass index>25 kg/m2 and diagnosis of T2D in the past 3 years and randomise them to a tailored DEW or a DE programme. Participants will attend measurement appointments at a local general practitioner practice or research centre at baseline, 6 and 12 months. The primary outcome is 12-month change in glycated haemoglobin. The effect of the intervention on the primary outcome will be estimated and tested using a linear regression model (analysis of covariance) including randomisation group and adjusted for baseline value of the outcome and the randomisation stratifiers. Participants will be included in the group to which they were randomised, under the intention-to-treat principle. Secondary outcomes include 6-month and 12-month changes in body weight, body fat percentage, systolic and diastolic blood pressure and lipid profile; probability of achieving good glycaemic control; probability of achieving remission from diabetes; probability of losing 5% and 10% body weight and modelled cardiovascular risk (UKPDS). An intention-to-treat within-trial cost-effectiveness analysis will be conducted from NHS and societal perspectives using participant-level data. Qualitative interviews will be conducted with participants to understand why and how the programme achieved its results and how participants manage their weight after the programme ends.Ethics and disseminationEthical approval was received from East of Scotland Research Ethics Service on 15 May 2018 (18/ES/0048). This protocol (V.3) was approved on 19 June 2019. Findings will be published in peer-reviewed scientific journals and communicated to other stakeholders as appropriate.Trial registration numberISRCTN18399564.

Project description:ObjectivesTo examine context-specific delivery factors, facilitators and barriers to implementation of the Diabetes Community Exercise and Education Programme (DCEP) for adults with type 2 diabetes (T2D) using the Reach, Effectiveness, Adoption, Implementation and Maintenance framework.DesignA qualitative evaluation embedded within the DCEP pragmatic randomised controlled trial. Data collected via focus groups and interviews and analysed thematically.SettingCommunity-based in two cities (Dunedin and Invercargill) in the lower south island of New Zealand.ParticipantsSeventeen adults diagnosed with T2D attending DCEP and 14 healthcare professionals involved in DCEP delivery.InterventionDCEP is a twice weekly session of exercise and education over 12 weeks, followed by a twice weekly ongoing exercise class.ResultsWhile our reach target was met (sample size, ethnic representation), the randomisation process potentially deterred Māori and Pasifika from participating. The reach of DCEP may be extended through the use of several strategies: promotion of self-referral, primary healthcare organisation ownership and community champions. DCEP was considered effective based on perceived benefit. The social and welcoming environment created relationships and connections. People felt comfortable attending DCEP and empowered to learn. Key to implementation and adoption was the building of trusting relationships with local health providers and communities. This takes time and care and cannot be rushed. Training of staff and optimising communication needed further attention. To maintain DCEP, delivery close to where people live and a generic approach catering for people with multiple chronic conditions may be required.ConclusionsFor success, lifestyle programmes such as DCEP, need time and diligence to build and maintain networks and trust. Beyond frontline delivery staff and target populations, relationships should extend to local healthcare organisations and communities. Access and ongoing attendance are enabled by healthcare professionals practicing in a nuanced person-centred manner; this, plus high staff turnover, necessitates ongoing training.Trial registration numberACTRN12617001624370.

Project description:IntroductionExercise interventions have a strong evidence base for falls prevention. However, exercise can be challenging to implement and often has limited reach and poor adherence. Digital technology provides opportunities for both increased access to the intervention and support over time. Further knowledge needs to be gained regarding the effectiveness of completely self-managed digital exercise interventions. The main objective of this study is to compare the effectiveness of a self-managed digital exercise programme, Safe Step, in combination with monthly educational videos with educational videos alone, on falls over 1 year in older community-dwelling adults.Methods and analysisA two-arm parallel randomised controlled trial will be conducted with at least 1400 community-living older adults (70+ years) who experience impaired balance. Participants will be recruited throughout Sweden with enrolment through the project website. They will be randomly allocated to either the Safe Step exercise programme with additional monthly educational videos about healthy ageing and fall prevention, or the monthly education videos alone. Participants receiving the exercise intervention will be asked to exercise at home for at least 30 min, 3 times/week with support of the Safe Step application. The primary outcome will be rate of falls (fall per person year). Participants will keep a fall calendar and report falls at the end of each month through a digital questionnaire. Further assessments of secondary outcomes will be made through self-reported questionnaires and a self-test of 30 s chair stand test at baseline and 3, 6, 9 and 12 months after study start. Data will be analysed according to the intention-to-treat principle.Ethics and disseminationEthical approval was obtained by The Regional Ethical Review Board in Umeå (Dnr 2018/433-31). Findings will be disseminated through the project web-site, peer-reviewed journals, national and international conferences and through senior citizen organisations' newsletters.Trial registration numberNCT03963570.

Project description:BackgroundAlthough older adults are at an increased risk of atherosclerotic cardiovascular disease (ASCVD), the effect of an integrated exercise and cardiovascular health education programme based on self-efficacy theory has not been well investigated among older adults. This study aims at examining the effect of this programme on community-dwelling older adults at risk of ASCVD concerning physical activity level, exercise self-efficacy and ASCVD risk profile.MethodsA parallel two-arm randomised controlled trial with pretest-posttest design will be performed among 190 Chinese community-dwelling adults aged 60 or above in elderly community centres of the Guangdong-Hong Kong-Macao Greater Bay Area. Eligible participants will be randomised by computerised generation. Experimental group will receive a 12-week integrated exercise and cardiovascular health education programme, which comprises a one-hour group-based health education talk conducted at Week 1, a booklet, a lecture video, a tailor-made exercise video, and a booster intervention by text messaging starting from Week 1 to Week 12. Control group will receive placebo intervention including a talk on basic health issues, a lecture video and corresponding leaflet. The outcomes will be investigated through self-report questionnaires and physiological evaluations at baseline, Week 12, Week 24, and Week 36. Physical activity level, exercise self-efficacy and ASCVD risk profile will be assessed, with physical activity level at Week 24 considered the primary outcome. The main intervention effect (group differences on continuous outcome variables) will be examined via Generalized Estimating Equations with identity link.DiscussionThis study findings will provide clues to the effect of the integrated exercise and cardiovascular health education programme, which is theoretically underpinned with self-efficacy theory, in older adults at risk of ASCVD. It will also enhance the quality of community health education by providing insight into the effective teaching strategies targeting older adults.Trial registrationThis study has been registered on ChinicalTrial.gov (Trial ID: NCT05434273).

Project description:IntroductionType 2 diabetes mellitus (T2DM) is one of the world's fastest growing health problems. Asians have a strong ethnic predisposition for T2DM, developing T2DM at a lower degree of obesity and at younger ages than other ethnic groups. T2DM has a gradual onset, with most individuals progressing through a pre-diabetic state, providing an opportunity to prevent T2DM and its complications. This study aims to evaluate the effectiveness of a community-based lifestyle intervention programme on weight loss and improvements in insulin sensitivity and cardiometabolic profiles in Chinese adults with pre-diabetes.Methods and analysisThis study is a 12-month, assessor-blinded randomised controlled trial. Adults with pre-diabetes (aged 40-64 years, n=180) with pre-diabetes are randomised into either an intervention group (receiving group-based lifestyle interventions) or a control group (receiving text messages containing health information). The intervention programme targets a weight loss of 5% during the first 6 months by restricting caloric intake and increasing physical activity. Participants in the intervention group will attend six group sessions and two individual face-to-face diet counselling sessions during the first 6 months, followed by monthly telephone support during the 6-month maintenance phase. Participants in the control group will receive monthly text messages containing general health information only. The primary outcome is weight loss (%). Secondary outcomes include insulin sensitivity (assessed using fasting insulin level and homeostatic model assessment of insulin resistance), glycaemic control (assessed using glycated haemoglobin level), lipid profile, blood pressure, carotid artery thickness, dietary intake and level of physical activity. Intention-to-treat analysis will be conducted using a generalised linear mixed effects model with a logit link and linear mixed models.Ethics and disseminationThis study has been approved by the relevant research ethics committee. The results will be disseminated through peer-reviewed journals and scientific presentations.Trial registration numberNCT03609697.

Project description:BackgroundBreastmilk is the ideal nutrition for infants, and breastfeeding protects infants and mothers from a range of adverse health outcomes. In Denmark, most mothers initiate breastfeeding but many cease within the first months resulting in just 14% reaching the World Health Organization recommendation of six months of exclusive breastfeeding. Furthermore, the low breastfeeding proportion at six months is characterised by a marked social inequality. A previous intervention tested in a hospital setting succeeded in increasing the proportion of mothers breastfeeding exclusively at six months. However, most breastfeeding support is provided within the Danish municipality-based health visiting programme. Therefore, the intervention was adapted to fit the health visiting programme and implemented in 21 Danish municipalities. This article reports the study protocol, which will be used to evaluate the adapted intervention.MethodsThe intervention is tested in a cluster-randomised trial at the municipal level. A comprehensive evaluation approach is taken. The effectiveness of the intervention will be evaluated using survey and register data. Primary outcomes are the proportion of women who breastfeed exclusively at four months postpartum and duration of exclusive breastfeeding measured as a continuous outcome. A process evaluation will be completed to evaluate the implementation of the intervention; a realist evaluation will provide an understanding of the mechanisms of change characterising the intervention. Finally, a health economic evaluation will assess the cost-effectiveness and cost-utility of this complex intervention.DiscussionThis study protocol reports on the design and evaluation of the Breastfeeding Trial - a cluster-randomised trial implemented within the Danish Municipal Health Visiting Programme from April 2022 to October 2023. The purpose of the programme is to streamline breastfeeding support provided across healthcare sectors. The evaluation approach is comprehensive using a multitude of data to analyse the effect of the intervention and inform future efforts to improve breastfeeding for all.Trial registrationProspectively registered with Clinical Trials NCT05311631 https://clinicaltrials.gov/ct2/show/NCT05311631.

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Protocol for a randomised controlled trial to evaluate the effectiveness of the diabetes community exercise and education programme (DCEP) for long-term management of diabetes.

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Protocol for a randomised controlled trial to evaluate the effectiveness of the diabetes community exercise and education programme (DCEP) for long-term management of diabetes.

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