Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000549325
Ethics application status
Approved
Date submitted
10/04/2017
Date registered
19/04/2017
Date last updated
14/05/2019
Date data sharing statement initially provided
14/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
BetaMe. An innovative management of diabetes and prediabetes with a comprehensive digital health programme: a randomised controlled trial.
Scientific title
BetaMe. Impact of a comprehensive digital health programme on HbA1c and weight at 12 months for people with diabetes and prediabetes: a randomised controlled trial.
Secondary ID [1] 291658 0
Nil
Universal Trial Number (UTN)
U1111-1189-9094
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes 302811 0
prediabetes 302812 0
Condition category
Condition code
Metabolic and Endocrine 302306 302306 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 monitors the community to ensure nothing unsafe (like personal details, or negative health messages) is shared, and that people are supported and supportive. They will also reinforce key messages, highlight local events in the area, start conversations and welcome new people to the community.

Timing of intervention: In the first 16 weeks of the programme, participants will set goals, work with health coaches, receive the evidence-based modules and be encouraged to use goal tracking and participate in the peer support programme. After that time, participants will be encouraged to continue tracking and participating in peer support, for the remainder of the 52-week programme. Information from the modules is available for the entire 52-week period.

At the end of the study, there will be a process evaluation which will include assessments of implementation of the BetaMe programme and mechanisms of action.
Data will be collected from three sources: 1) from the mobile/web platform to identify key usage patterns; 2) with consent from the participants, health coaches will record audio interactions with participants and will log key reasons for contact (a random subset of the first coaching sessions will be assessed by the research team for consistency with the log); 3) participants will be invited to provide individual feedback on the acceptability and usefulness of the intervention at the end of the study period. Focus groups, lasting approximately one hour each, will be held in each region to obtain in-depth feedback about the intervention and how participants interacted with it.
Usage will be described, and linked to outcomes using standard quantitative analytic approaches (for example, proportions accessing health coaches will be reported, with 95% confidence intervals; frequency of accessing health coaches or engaging online will be reported as median access with range/interquartile range). Focus group data will be coded thematically, with key issues identified.
Intervention code [1] 297743 0
Lifestyle
Intervention code [2] 297744 0
Behaviour
Intervention code [3] 297770 0
Prevention
Comparator / control treatment
Participants in the control arm will receive usual care. For diabetics this would include an annual diabetic review to monitor glycaemic control and assess the patient for the presence of any diabetic complications and a review of treatment. In addition it could include education and advice on lifestyle factors such as diet and exercise provided by a trained practice nurse or diabetes specialist nurse. For Prediabetics usual care would include lifestyle advice and education about diet and exercise and an annual HbA1c.

Participants in the control arm will also be provided with standard information about prediabetes and T2DM and its management, from resources produced and provided by Diabetes NZ (Pamphlets entitled 'Pre-diabetes'; 'Diabetes and Healthy Food Choices'; 'Live well with diabetes'. available at http://www.diabetes.org.nz/resources_and_publications)/printable_pamphlets)
Control group
Active

Outcomes
Primary outcome [1] 301715 0
Change in HbA1c. Measured using whole blood sample collected in EDTA tube (2mls minimum) using Variant Turbo Ion Exchange HPLC.
Timepoint [1] 301715 0
At 12 months after study recruitment compared with baseline
Primary outcome [2] 301716 0
Change in weight. Measured in kilograms using calibrated digital scales.
Timepoint [2] 301716 0
At 12 months after study recruitment compared with baseline
Secondary outcome [1] 333660 0
Change in waist circumference. Measured in millimetres using tape measure.
Timepoint [1] 333660 0
At 4 and 12 months after study recruitment compared with baseline
Secondary outcome [2] 333661 0
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.
Timepoint [2] 333661 0
At 4 and 12 months after study recruitment compared with baseline
Secondary outcome [3] 333662 0
Change in self-management measured using the Partners in Health Scale (Smith D, et al. Qual Life Res 2017; 26(1): 149-59.)
Timepoint [3] 333662 0
At 4 and 12 months after study recruitment compared with baseline
Secondary outcome [4] 333663 0
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.).
Timepoint [4] 333663 0
At 4 and 12 months after study recruitment compared with baseline
Secondary outcome [5] 333664 0
Quality of life as measured by the EuroQol group’s EQ-5D-5L instrument (Eurocare Working Group. Health Policy 1990; 16: 199-208.)
Timepoint [5] 333664 0
At 4 and 12 months after study recruitment compared with baseline
Secondary outcome [6] 333666 0
Change in HbA1c. Measured using whole blood sample collected in EDTA tube (2mls minimum) using Variant Turbo Ion Exchange HPLC.
Timepoint [6] 333666 0
At 4 months after study recruitment compared with baseline
Secondary outcome [7] 333667 0
Change in Weight. Measured in kilograms using calibrated digital scales.
Timepoint [7] 333667 0
At 4 months after study recruitment compared with baseline
Secondary outcome [8] 333750 0
Change of score in diabetes-specific outcomes using the Diabetes Distress Scale (Fisher L, et al. Ann Family Med 2008; 6(3): 246-52.).
Timepoint [8] 333750 0
At 4 and 12 months after study recruitment compared with baseline
Secondary outcome [9] 333752 0
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.
Timepoint [9] 333752 0
At 4 months relative to baseline, and 12 months relative to 4 months.
Secondary outcome [10] 333753 0
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.
Timepoint [10] 333753 0
At 4 months relative to baseline, and 12 months relative to 4 months.
Secondary outcome [11] 333754 0
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.
Timepoint [11] 333754 0
At 4 months relative to baseline, and 12 months relative to 4 months.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will not be eligible for the study if they:
Are pregnant
Have cognitive impairment likely to be sufficient to hinder their understanding of the study or the programme, as this may negatively affect their self-management behaviour.56
Are unable to read and write in English.
Unable to use phone or computer due to physical disability such as poor eyesight or manual dexterity.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be centrally determined from within the REDCap electronic data capture platform after the patient is enrolled in the study (following the first assessment with the research nurse and when full eligibility based on current HbA1c level has been determined). The randomisation list will not be visible to the team member(s) requesting the allocation, and these individuals will only have details on the patient ID, practice, and ethnicity when requesting allocation for any patient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Based upon their baseline HbA1c test results (prediabetes or diabetes range), participants will be randomised into the intervention or control arm (1:1 allocation) using a computer generated randomisation schedule stratified by participating practice and ethnicity. To ensure that equal numbers are allocated to each study arm, randomisation lists will be blocked. The exact length of each randomisation block will be kept in a separate document held by the PI, project manager and project statistician, and this will not be available to the team member(s) responsible for determining allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size

The study is powered in the pre-diabetic group to detect a difference of 2.5 mmol/mol between study arms (80% power, alpha = 0.05, presuming SD = 5.5 mmol/mol). This requires a sample size of 76 per study arm (152 total). The sample size for the diabetic group is powered to detect a minimal clinically important difference of 5.5 mmol/mol between study arms (80% power, alpha for comparison = 0.05, presuming a standard deviation of 15 mmol/mol in this group). This requires a sample size of 117 per study arm (234 total). This gives a combined sample size of 386 people with prediabetes and people with diabetes. To account for loss of precision due to patients lost to follow-up (projected at 10%), we will recruit 430 patients at baseline (note that all participants will be included in linear mixed models analysis, even if missing final endpoint data. This reduces bias in estimating effect size, but there is still loss in statistical power compared to having complete follow-up data.)

For analysis of weight differences between study arms, pre-diabetic and diabetic patients will be pooled prior to analysis. Analysis will be stratified on patient group to account for the pooled approach, and we will also report weight differences by study arm within each patient group. The comparison of weight loss in the combined patient group is powered to detect a difference between study arms of 5kg (80% power, alpha = 0.05, SD = 15kg in this group). This requires a sample size of 142 per study arm (284 total), which is below the combined sample size for the HbA1c outcome.

Analysis:
All primary analyses will be based on intention to treat. Both HbA1c and weight will be analysed as continuous variables. For the HbA1c primary outcome, analysis will be conducted both combined and separately for pre-diabetic and diabetic groups. For weight, the primary analysis will combine pre-diabetic and diabetic participants. Analysis will use linear mixed models, comparing mean outcome levels between intervention and control arms at the 12-month endpoint, adjusted for initial HbA1c level (accounts for baseline differences in outcome) and for other important baseline covariates, (age, gender, ethnicity, weight). The analysis will include the 4 month measurements, providing some information for those individuals subsequently lost to follow-up and hence missing final outcome data (mixed models analysis treats these final data as missing at random conditional on baseline and intermediate covariates i.e. these individuals are expected on average to have final outcomes similar to other people with the same baseline covariates and HbA1c trajectories). As the study involves repeated measures data, these models will include random effects for individuals to account for correlation between measurements from the same person at different follow-up times.

We will also estimate differences in HbA1c and weight endpoints by study arm for each of the stratified randomisation ethnic groups (Maori, Pacific, other ethnicities), and will report the mean difference and 95% confidence interval for each these. Proportions of patients meeting HbA1c and weight-loss targets will also be analysed by ethnic group with logistic regression (adjusted for baseline covariates), and adjusted absolute risk differences in treatment outcomes will be computed to quantify treatment effectiveness.

Analysis of self-reported outcomes will be conducted in a similar way, with some of these results being incorporated into the process evaluation (answering questions such as the extent to which improvements in self-reported patient management are associated with reduced HbA1c).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/05/2017
Actual
9/06/2017
Date of last participant enrolment
Anticipated
1/11/2017
Actual
24/04/2018
Date of last data collection
Anticipated
30/11/2018
Actual
23/04/2019
Sample size
Target
430
Accrual to date
Final
429
Recruitment outside Australia
Country [1] 8787 0
New Zealand
State/province [1] 8787 0
Wellington and Midlands

Funding & Sponsors
Funding source category [1] 296157 0
Government body
Name [1] 296157 0
Health Research Council
Country [1] 296157 0
New Zealand
Funding source category [2] 296158 0
Government body
Name [2] 296158 0
Ministry of Health
Country [2] 296158 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Wellington
Address
23 Mein St, Newtown, Wellington 6242,New Zealand
Country
New Zealand
Secondary sponsor category [1] 295060 0
None
Name [1] 295060 0
Address [1] 295060 0
Country [1] 295060 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297403 0
Central Health and Disability Ethics Committee:
Ethics committee address [1] 297403 0
Ethics committee country [1] 297403 0
New Zealand
Date submitted for ethics approval [1] 297403 0
03/03/2017
Approval date [1] 297403 0
27/03/2017
Ethics approval number [1] 297403 0
17/CEN/49

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1962 1962 0 0
/AnzctrAttachments/372718-Version 1.2_ BetaMe Protocol_MASTER_1Aug_2017.docx (Protocol)

Contacts
Principal investigator
Name 73930 0
Prof Diana Sarfati
Address 73930 0
Department of Public Health
University of Otago, Wellington
PO Box 7343
Newtown
Wellington 6242
New Zealand
Country 73930 0
New Zealand
Phone 73930 0
+6449186042
Fax 73930 0
Email 73930 0
[email protected]
Contact person for public queries
Name 73931 0
Melissa McLeod
Address 73931 0
Department of Public Health
University of Otago, Wellington
PO Box 7343
Newtown
Wellington 6242
New Zealand
Country 73931 0
New Zealand
Phone 73931 0
+64 4 3855541
Fax 73931 0
Email 73931 0
[email protected]
Contact person for scientific queries
Name 73932 0
Melissa McLeod
Address 73932 0
Department of Public Health
University of Otago, Wellington
PO Box 7343
Newtown
Wellington 6242
New Zealand
Country 73932 0
New Zealand
Phone 73932 0
+64 4 3855541
Fax 73932 0
Email 73932 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We are as yet undecided on this


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA mobile- And web-based health intervention program for diabetes and prediabetes self-management (BetaMe/Melon): Process evaluation following a randomized controlled trial.2020https://dx.doi.org/10.2196/19150
N.B. These documents automatically identified may not have been verified by the study sponsor.