A Text-Messaging and Pedometer Program to Promote Physical Activity in People at High Risk of Type 2 Diabetes: The Development of the PROPELS Follow-On Support Program.

BACKGROUND: Mobile technologies for health (mHealth) represent a promising strategy for reducing type 2 diabetes (T2DM) risk. The PROPELS trial investigates whether structured group-based education alone or supplemented with a follow-on support program combining self-monitoring with pedometers and tailored text-messaging is effective in promoting and maintaining physical activity among people at high risk of T2DM. OBJECTIVE: This paper describes the iterative development of the PROPELS follow-on support program and presents evidence on its acceptability and feasibility. METHODS: We used a modified mHealth development framework with four phases: (1) conceptualization of the follow-on support program using theory and evidence, (2) formative research including focus groups (n=15, ages 39-79 years), (3) pre-testing focus groups using a think aloud protocol (n=20, ages 52-78 years), and (4) piloting (n=11). Analysis was informed by the constant comparative approach, with findings from each phase informing subsequent phases. RESULTS: The first three phases informed the structure, nature, and content of the follow-on support program, including the frequency of text messages, the need for tailored content and two-way interaction, the importance of motivational messages based on encouragement and reinforcement of affective benefits (eg, enjoyment) with minimal messages about weight and T2DM risk, and the need for appropriate language. The refined program is personalized and tailored to the individual's perceived confidence, previous activity levels, and physical activity goals. The pilot phase indicated that the program appeared to fit well with everyday routines and was easy to use by older adults. CONCLUSIONS: We developed a feasible and innovative text messaging and pedometer program based on evidence and behavior change theory and grounded in the experiences, views, and needs of people at high diabetes risk. A large scale trial is testing the effectiveness of this 4-year program over and above structured group education alone. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 83465245; http://www.controlled-trials.com/ISRCTN83465245/83465245 (Archived by WebCite at http://www.webcitation.org/6dfSmrVAe)

PRomotion Of Physical activity through structured Education with differing Levels of ongoing Support for people at high risk of type 2 diabetes (PROPELS): study protocol for a randomized controlled trial.

BACKGROUND: The prevention of type 2 diabetes is recognised as a health care priority. Lifestyle change has proven effective at reducing the risk of type 2 diabetes, but limitations in the current evidence have been identified in: the promotion of physical activity; availability of interventions that are suitable for commissioning and implementation; availability of evidence-based interventions using new technologies; and physical activity promotion among ethnic minorities. We aim to investigate whether a structured education programme with differing levels of ongoing support, including text-messaging, can increase physical activity over a 4 year period in a multi-ethnic population at high risk of diabetes. METHODS/DESIGN: A multi-centre randomised controlled trial, with follow-up at 12 and 48 months. The primary outcome is change in ambulatory activity at 48 months. Secondary outcomes include changes to markers of metabolic, cardiovascular, anthropometric and psychological health along with cost-effectiveness. Participants aged 40-74 years for White European, or 25-74 years for South Asians, with an HbA1c value of between 6.0 and < 6.4% (42 and 47 mmol/mol) or with a previously recorded plasma glucose level or HbA1c value within the high risk (prediabetes) range within the last five years, are invited to take part in the trial. Participants are identified through primary care, using an automated diabetes risk score within their practice database, or from a database of previous research participants. Participants are randomly assigned to either: 1) the control group who receive a detailed advice leaflet; 2) the Walking Away group, who receive the same leaflet and attend a 3 hour structured education programme with annual maintenance sessions delivered in groups; or 3) the Walking Away Plus group, who receive the leaflet, attend the structured education programme with annual maintenance sessions, plus receive follow-on support through highly-tailored text-messaging and telephone calls to help to aid pedometer use and behaviour change. DISCUSSION: This study will provide new evidence for the long-term effectiveness of a structured education programme focused on physical activity, conducted within routine care in a multi-ethnic population in the UK. It will also investigate the impact of different levels of ongoing support and the cost-effectiveness of each intervention. TRIAL REGISTRATION: ISRCTN83465245 Trial registration date: 14/06/2012.The trial is funded by the Health Technology Assessment (HTA) Programme, National Institute for Health research. TY, MJD and KK are also supported by the NIHR Lifestyle and Physical Activity Biomedical Research Unit which is a partnership between University Hospitals of Leicester NHS Trust, Loughborough University and the University of Leicester and the NIHR Collaboration for Leadership in Applied Health Research and Care – East Midlands (NIHR CLAHRC – EM).This is the final version. It was first published by BioMed Central at http://www.trialsjournal.com/content/16/1/289

Development of an Interactive Lifestyle Programme for Adolescents at Risk of Developing Type 2 Diabetes: PRE-STARt

Background: Type 2 diabetes (T2D) is increasing in young people. Reporting on the processes used when developing prevention interventions is needed. We present the development of a family-based interactive lifestyle intervention for adolescents with risk factors for T2D in the future. Method: A multidisciplinary team in the UK site led the intervention development process with sites in Portugal, Greece, Germany and Spain. Potential programme topics and underpinning theory were gathered from literature and stakeholders. A theoretical framework based on self-efficacy theory and the COM-B (capability, opportunity, motivation, behaviour) model was developed. Sessions and supporting resources were developed and refined via two iterative cycles of session and resource piloting, feedback, reflection and refinement. Decision on delivery and content were made by stakeholders (young people, teachers, parents, paediatricians) and all sites. Materials were translated to local languages. Site-specific adaptations to the language, content and supporting resources were made. Results: The “PRE-STARt” programme is eight 90-min interactive sessions with supporting curriculum and resources. Iterative development work provided valuable feedback on programme content and delivery. Conclusion: Reporting on the intervention development process, which includes stakeholder input, could yield a flexible approach for use in this emerging ‘at risk’ groups and their families

Promoting physical activity in a multi-ethnic population at high risk of diabetes: the 48-month PROPELS randomised controlled trial.

BackgroundPhysical activity is associated with a reduced risk of type 2 diabetes and cardiovascular disease but limited evidence exists for the sustained promotion of increased physical activity within diabetes prevention trials. The aim of the study was to investigate the long-term effectiveness of the Walking Away programme, an established group-based behavioural physical activity intervention with pedometer use, when delivered alone or with a supporting mHealth intervention.MethodsThose at risk of diabetes (nondiabetic hyperglycaemia) were recruited from primary care, 2013-2015, and randomised to (1) Control (information leaflet); (2) Walking Away (WA), a structured group education session followed by annual group-based support; or (3) Walking Away Plus (WAP), comprising WA annual group-based support and an mHealth intervention delivering tailored text messages supported by telephone calls. Follow-up was conducted at 12 and 48 months. The primary outcome was accelerometer measured ambulatory activity (steps/day). Change in primary outcome was analysed using analysis of covariance with adjustment for baseline, randomisation and stratification variables.ResultsOne thousand three hundred sixty-six individuals were randomised (median age = 61 years, ambulatory activity = 6638 steps/day, women = 49%, ethnic minorities = 28%). Accelerometer data were available for 1017 (74%) individuals at 12 months and 993 (73%) at 48 months. At 12 months, WAP increased their ambulatory activity by 547 (97.5% CI 211, 882) steps/day compared to control and were 1.61 (97.5% CI 1.05, 2.45) times more likely to achieve 150 min/week of moderate-to-vigorous physical activity. Differences were not maintained at 48 months. WA was no different to control at 12 or 48 months. Secondary anthropometric and health outcomes were largely unaltered in both intervention groups apart from small reductions in body weight in WA (~ 1 kg) at 12- and 48-month follow-up.ConclusionsCombining a pragmatic group-based intervention with text messaging and telephone support resulted in modest changes to physical activity at 12 months, but changes were not maintained at 48 months.Trial registrationISRCTN 83465245 (registered on 14 June 2012)

Drivers with and without Obesity Respond Differently to a Multi-Component Health Intervention in Heavy Goods Vehicle Drivers

Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme (reference: NIHR PHR 15/190/42). The study was also supported by the NIHR Leicester Biomedical Research Centre which is a partnership between University Hospitals of Leicester NHS Trust, Loughborough University and the University of Leicester. Laura Gray is supported by the National Institute for Health Research (NIHR) Applied Research Collaboration East Midlands (ARC EM). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. Funding to cover the intervention costs (Fitbits and cab workout equipment) was provided by the Higher Education Innovation Fund, via the Loughborough University Enterprise Projects Group. The Colt Foundation provided funding for a PhD Studentship, awarded to Amber Guest (reference: JD/618), which covered Amber’s time and contributions to this project. The funders played no role in study design, data collection, data analysis, data interpretation or in the preparation of this manuscript.Peer reviewedPublisher PD

The structured health intervention for truckers (SHIFT) cluster randomised controlled trial : a mixed methods process evaluation

Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme (reference: NIHR PHR 15/190/42). The study was also supported by the NIHR Leicester Biomedical Research Centre which is a partnership between University Hospitals of Leicester NHS Trust, Loughborough University, and the University of Leicester. Laura Gray is supported by the National Institute for Health Research (NIHR) Applied Research Collaboration East Midlands (ARC EM). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. Funding to cover intervention costs (Fitbits, cab workout equipment) was provided by the Higher Education Innovation Fund, via the Loughborough University Enterprise Projects Group. The Colt Foundation provided funding for a PhD Studentship, awarded to Amber Guest (reference: JD/618), which covered Amber’s time and contributions to this project. None of the funding bodies had any role in study design; election, synthesis, and interpretation of data; writing of the report; or the decision to submit the manuscript for publication. Acknowledgements We gratefully acknowledge the support provided by senior Health and Safety personnel and Transport Managers at our partner logistics company in facilitating this research. We also thank all participants for taking part. We are grateful to the independent members of the Trial Steering Committee for their continued support and advice throughout the trial: Dr. Derrick Bennett, Prof Emma McIntosh, Prof Petra Wark and Mr. Paul Gardiner.Peer reviewedPublisher PD

Development of a lifestyle intervention using the MRC framework for diabetes prevention in people with impaired glucose regulation

A B S T R AC T Background We report development of a group-based lifestyle intervention, Let&apos;s Prevent, using the UK Medical Research Council (MRC) framework, and delivered by structured education to prevent type 2 diabetes mellitus (T2DM) in people with impaired glucose regulation (IGR) in a UK multi-ethnic population. Methods Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (DESMOND) is the first national T2DM programme that meets National Institute for Health and Care Excellence criteria and formed the basis for Let&apos;s Prevent. An iterative cycle of initial development, piloting, collecting and collating qualitative and quantitative data, and reflection and modification, was used to inform and refine lifestyle intervention until it was fit for evaluation in a definitive randomized controlled trial (RCT). The programme encouraged IGR self-management using simple, non-technical language and visual aids. Results Qualitative and quantitative data suggested that intervention resulted in beneficial short-term behaviour change such as healthier eating patterns, improved health beliefs and greater participant motivation and empowerment. We also demonstrated that recruitment strategy and data collection methods were feasible for RCT implementation. Conclusions Let&apos;s Prevent was developed following successful application of MRC framework criteria and the subsequent RCT will determine whether it is feasible, reliable and transferable from research into a real-world NHS primary healthcare setting. Trial Registration ISRCTN80605705. Keywords complex intervention, diabetes prevention, impaired glucose regulation, structured education Introduction Screening studies carried out in primary care in the UK 1 have shown that screening for type 2 diabetes mellitus (T2DM) will identify around 15% of middle aged adults with impaired glucose tolerance or impaired fasting glucose, collectively termed impaired glucose regulation (IGR) and also known as pre-diabetes mellitus. 2 IGR is considered to be a high-risk state for T2DM, cardiovascular disease (CVD) and increased mortality 3,4 and is now referred to as &apos;at high risk of developing diabetes&apos; under new guidelines on terminology. There is evidence that, in people with IGR, lifestyle modifications can substantially reduce the risk of developing T2DM. 6 Screening and lifestyle interventions are also likely to be costeffective. 7 The Diabetes Prevention Programme 8 and the Finnish Prevention study 9 showed that lifestyle programmes addressing weight loss, healthy diet and physical activity reduce the risk of developing T2DM in those with IGR by 58%. Successful lifestyle programmes have also been carried out in many other countries, including India, 10 China 11 and Japan. 12 There is limited evidence, however, regarding the feasibility of translating this research into practice. Many research-based prevention programmes have involved multiple one-to-one counselling sessions. The Diabetes Prevention Programme had a median of 20 individual counselling sessions over a 4-year period. 9 The intensity of such an intervention, even if cost-effective in the long term, is likely to place acute strain on healthcare resources in the short term. Even resource-rich countries, such as Germany and Finland, where diabetes prevention is a public health priority, have been unable to replicate the intensive nature of diabetes prevention programmes when implemented into clinical practice. 17 New guidelines from the National Institute for Health and Care Excellence (NICE) state that those identified with a moderate or high risk of developing T2DM should be offered culturally appropriate information or support, in a range of formats and languages, including structured education, to help them change their lifestyle. 5 Structured education refers to group-based patient-centred educational programmes that have a clear philosophy and a written curriculum with supporting resources, are underpinned by appropriate learning and psychological theory, and are evidence-based and delivered by trained, quality assessed educators. 19 Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (DESMOND) is the first national programme for T2DM that meets NICE criteria 20,21 and a randomized controlled trial (RCT) has demonstrated its effectiveness in improving weight, smoking behaviours and illness beliefs. 21 The DESMOND model is based on an empowerment philosophy that sees the participant as capable and responsible for their own health decisions and behaviours. The UK Medical Research Council (MRC) Framework for Complex Interventions to Improve Health has internationally recognized criteria to guide the development and evaluation of health behaviour change programmes. The most recent MRC guidance suggests including the following phases: development, feasibility and piloting, evaluation and implementation 23 There is an urgent need to design and test prevention programmes that meet the needs of ethnically diverse communities and are feasible, cost-effective and replicable in a real-world UK healthcare setting. The lifestyle intervention described was developed to meet this need and is currently being formally evaluated in an RCT. Methods Study design and recruitment The Let&apos;s Prevent intervention was developed by a core multidisciplinary team in collaboration with the DESMOND collaborative and the National Physical Activity Centre in Loughborough. It was designed as a group educational programme with a written curriculum suitable for the broadest range of participants, to be deliverable in a community setting for ease of access for patients, and to have the potential for integration into future routine clinical care. The session content was founded on a sound evidence base and guided by a review of the literature surrounding nutrition, exercise and educational principles with pragmatic decisions on best practice where the evidence was ambiguous, lacking or conflicting. Using the DESMOND model, the programme was 6 h long, deliverable in either one full day or as two half-day equivalents. It was designed to be facilitated by two trained healthcare professionals (educators) to a group of between 5 and 12 participants with IGR, who had the option of bringing an accompanying person. It was delivered as two versions. The first was broadly suitable for most White European groups, referred to as the Let&apos;s Prevent programme, and the second was adapted to suit SA patient groups and referred to as the SA Let&apos;s Prevent programme. Both versions of the educational intervention and the educator training programme were modelled and refined using an iterative process, including piloting, feedback, analysis, reflection and modification, based on a methodology previously developed for modifying an educational programme. 30 Key to the process was the collection and analysis of qualitative and quantitative data. A degree of objectivity and a high level of rigour were attained by involving academic researchers in this process. The Qualitative data were gathered to ascertain the experiences of both participants and educators of engaging in the programme. Data were collected via observation, telephone and face-to-face interviews and focus groups. Flexible topic guides were developed by trainers and qualitative researchers to inform and facilitate the qualitative data collection process. The SA Let&apos;s Prevent programme was developed concurrently to address the needs of the SA population living in the UK, many of whom do not speak English. Core educational messages were identical to Let&apos;s Prevent but changes were made to ensure that food and activity messages were culturally relevant. Teaching resources (images and models) were developed to ensure that the programme was not reliant on the written word. A previous action research project The nutritional goals from the Diabetes Prevention Programme 8 and the Finnish Prevention Study 9 and the physical activity goals from the PREPARE stud

Development of an interactive lifestyle programme for adolescents at risk of developing type 2 diabetes : PRE-STARt

Background: Type 2 diabetes (T2D) is increasing in young people. Reporting on the processes used when developing prevention interventions is needed. We present the development of a family-based interactive lifestyle intervention for adolescents with risk factors for T2D in the future. Method: A multidisciplinary team in the UK site led the intervention development process with sites in Portugal, Greece, Germany and Spain. Potential programme topics and underpinning theory were gathered from literature and stakeholders. A theoretical framework based on self-efficacy theory and the COM-B (capability, opportunity, motivation, behaviour) model was developed. Sessions and supporting resources were developed and refined via two iterative cycles of session and resource piloting, feedback, reflection and refinement. Decision on delivery and content were made by stakeholders (young people, teachers, parents, paediatricians) and all sites. Materials were translated to local languages. Site-specific adaptations to the language, content and supporting resources were made. Results: The "PRE-STARt" programme is eight 90-min interactive sessions with supporting curriculum and resources. Iterative development work provided valuable feedback on programme content and delivery. Conclusion: Reporting on the intervention development process, which includes stakeholder input, could yield a flexible approach for use in this emerging 'at risk' groups and their families

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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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.</p> <p>Conclusion</p> <p>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.</p> <p>Trial registration</p> <p>The study is registered at ClinicalTrials.gov, study identifier: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01043770">NCT01043770</a>.</p