BetaMe. An innovative management of diabetes and prediabetes with a comprehensive digital health programme: a randomised controlled trial.

INTERVENTION: The intervention for this study is the BetaMe programme, which is an integrative evidence‐based self‐management programme for type two diabetes mellitus (T2DM) and prediabetes. Melon Health Ltd has been subcontracted to deliver the BetaMe programme to those in the intervention arm of the trial. Those randomised to the intervention arm will be enrolled on the BetaMe programme. It consists of four separate components; health coaches, provision of evidence‐based resources, goal tracking and peer support. BetaMe is internet‐based and delivered using both mobile and web‐based platforms. Initiating the BetaMe programme: Those participants randomised to the BetaMe programme (intervention arm) will be contacted by a health coach within ten working days of having their baseline blood test taken. The health coach will provide detail for patients to access an online tutorial about the BetaMe programme, including a short video orientating participants to the app and how to use it. Health coaching: The health coaches are all either qualified personal trainers or registered nurses trained in motivational interviewing, cognitive behavioural therapy, and nutrition, and have completed the Heart Foundation Pacific Heartbeat Community Nutrition course. Health coaches will arrange the first one‐on‐one session with participants. The purpose of this first session which is one‐hour is so that health coaches can work with participants to develop goals that are tailored according to their needs and values. The session follows a set format. Coaches use a number of standard conversation starters, and activities to work through with participants to establish what their values are, in order to develop goals that are relevant and meaningful to them. Maori and Pacific coaches will be available. Once these goals have been set and agreed on, participants’ goals are entered into their profile on the BetaMe system. Coaches will then continue to work with participants. Coaches will message participants weekly to check on their progress, reinforce information from the modules and arrange further meetings at frequencies that suit the participant (these can be weekly or fortnightly or less frequently if preferred). These subsequent meetings are around 15‐20 ins in length. All meetings with the coaches will be by audio or video, as per the participant’s preference. Participants are able to make appointments with or send messages to their coach through the BetaMe app. Clinical Governance of the health coaches will be provided by a health psychologist, who will spend one‐on‐one time with each coach on a fortnightly basis. Coaches will have access to a range of coaching resources , and will be supported by the project mental health lead (a general practitioner) and an experienced health coach. Coaches also regularly interact with one another via an online forum (separate from patient forums) to share any problems they are having and solutions. Health literacy: There are eight key education modules introduced to participants through an introduction to the module via the web and mobile platform with attached resources (videos, infographics, articles, tips, tools, meal ideas and mini‐quiz). The time spent on the modules is up to the participant, but would typically be less than two hours. The key messages in the modules are also reinforced in corresponding email newsletters, discussions on the newsfeed initiated by the Community Manager and by the participant’s coach. Every two weeks, a new module is released that presents participants with a range of topics that offer key messages to help them to learn about and manage their own health. The modules are: Week 0: Introduction to BetaMe and risk factors of prediabetes and Diabetes. Week 1‐2: Healthy Eating, Healthy Moving. Week 3‐4: Triggers and Habits. Week 5: Review your progress. Week 6‐7: Eating for Health. Week 8‐9: Drinks, Sleep and Shift Work. Week 10: Recap & Refresh, Week 11‐12: Problem Solving. Week 13‐14: Healthy Coping & Mindfulness. Week 15‐16: Reflection and Celebration. The content of these modules aligns with the Ministry of Health Guidelines for health eating and the Heart Foundation guidelines. Participants will have the option for one‐on‐one on‐line chats with their coach to discuss each new module. Goal tracking: Participants are encouraged to track their progress towards their goals (including healthy eating, physical activity, weight, happiness and sleep). They will be provided with a set of digital scales and a tape measure so they can take their own measurements and track their progress. They will be able to share these data with their health coach at any time, or with their doctor by email or at their next appointment. Peer support: The programme also includes peer support with real‐time chat within a private and secure online social network monitored by a Community Manager who is a registered nurse trained in nutrition. This person mon CONDITION: diabetes prediabetes PRIMARY OUTCOME: Change in HbA1c. Measured using whole blood sample collected in EDTA tube (2mls minimum) using Variant Turbo Ion Exchange HPLC. Change in weight. Measured in kilograms using calibrated digital scales. INCLUSION CRITERIA: The study will be based in two regions of New Zealand, Midlands and Greater Wellington. Participating practices are those based in these regions that are interested in being involved in the study and able to commit to the study timeframes and process requirements. Practice recruitment will be through an opt‐in process. Patients will be eligible for inclusion if they meet the following INCLUSION CRITERIA: Have a current HbA1c of 41‐70 mmol/mol (either from a test within three months prior to invitation to the study, or on the basis of an HbA1c test taken by the research team at invitation to the study). Are not currently on insulin treatment for diabetes Adults aged between 18‐75 years, enrolled in participating primary care practices. Have daily internet access (on any of computer/tablet/smartphone) Are able to provide informed consent. SECONDARY OUTCOME: Change in blood pressure. Measured using calibrated syphgmomanometer using standard approach (blood pressure measurement taken when participant has been sitting quietly for five minutes, without eating, drinking or smoking. They will be asked to have feet flat on the floor, with their back against the back of the chair, and their left arm straight on the table). Three measures will be taken with the lowest of the last two measures recorded. Change in dose of other oral hypoglycaemic agents (not metformin): categorised as 1) starting other oral hypoglycaemic agents in current time period; 2) increasing dose of other oral hypoglycaemic agents in current time period; 3) reducing dose of other oral hypoglycaemic agents in current time period or 4) stopping other oral hypoglycaemic agents in current time period. Data will be collected from patients, where possible verified from clinic records. Change in HbA1c. Measured using whole blood sample collected in EDTA tube (2mls minimum) using Variant Turbo Ion Exchange HPLC. Change in insulin dose: categorised as 1) starting insulin in current time period; 2) increasing dose of insulin in current time period; 3) reducing dose of insulin in current time period or 4) stopping insulin in current time period. Data will be collected from patients, where possible verified from clinic records. Change in metformin dose: categorised as 1) starting metformin in current time period; 2) increasing dose of metformin in current time period; 3) reducing dose of metformin in current time period or 4) stopping metformin in current time period. Data will be collected from patients, where possible verified from clinic records. Change in self‐management measured using the Partners in Health Scale (Smith D, et al. Qual Life Res 2017; 26(1): 149‐59.) Change in waist circumference. Measured in millimetres using tape measure. Change in Weight. Measured in kilograms using calibrated digital scales. Change of score in diabetes‐specific behaviours and outcomes measured using the Summary of Diabetes Self‐Care Activities tool, which assesses participants’ self‐care activities (Toobert DJ, et al. Diabetes Care 2000; 23(7): 943‐50.). Change of score in diabetes‐specific outcomes using the Diabetes Distress Scale (Fisher L, et al. Ann Family Med 2008; 6(3): 246‐52.). Quality of life as measured by the EuroQol group’s EQ‐5D‐5L instrument (Eurocare Working Group. Health Policy 1990; 16: 199‐208.)