ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622000710729

Ethics application status

Approved

Date submitted

6/05/2022

Date registered

17/05/2022

Date last updated

21/02/2023

Date data sharing statement initially provided

17/05/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Assessment of the effectiveness of the Defeat Diabetes Application (DDA) low carbohydrate diet and lifestyle intervention, in the self-management of type 2 diabetes.

Scientific title

Effectiveness of digitally delivered continuous care intervention on the self management of type 2 diabetes. A 12-month single-arm, pre-post intervention study.

Secondary ID [1]

Nil known

Secondary ID [2]

Defeat Diabetes Research Study

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Type 2 Diabetes

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This intervention requires the participants to follow the recommendations outlined in the Defeat Diabetes Application in order to make dietary and lifestyle changes over a 12-month period.
The Defeat Diabetes Application (DDA) is a subscription based commercial application for download on smartphone (Android and Apple OS). The DDA provides a guided educational program on specific low carbohydrate and lifestyle interventions to manage T2D.

This success of this study is heavily reliant on the support of community based GPs (who agree to help by signing a letter of support). Supporting GPs can then refer potential participants who they medically manage, with a diagnosis of Type 2 Diabetes (T2D) to the research team.
Members of the Royal Australian College of General Practitioners (RACGP) who support the research will be eligible for RACGP CPD Accredited Activity Self Directed - GP Group Research on completion of the study.
(A process evaluation survey addressing the requirements of the RACGP will be provided to supporting GPs at the completion of the study.)

Members of the Australian College of Rural and Remote Medicine (ACRRM), who participate may be eligible for CPD. This study is an accredited as an Educational Activity and an Outcome Measurement Activity.

After referral by their GP, screening for eligibility, consent to participate and baseline measurements are received, participants will be given free lifetime access to the Defeat Diabetes App, where they can access educational resources and a private Defeat Diabetes Facebook community group. (GPs who express interest in the study will also receive free lifetime access to the DDA and related resources.)

When participants first visit their GP, they will be asked to undergo laboratory bloodwork tests, blood pressure, waist circumference, height and weight measurements. Data will also need to be recorded at 3, 6 and 12 months by the participants GP and forwarded to the research team (with participants consent).

The research team will also send participants a set of online survey questionnaires at baseline, 3, 6 and 12 months, that will assess their physical activity levels, sleep, quality of life, diabetes distress and self-efficacy, adverse events reporting and in addition keep a record (for 3 days) of their dietary intake. At 12 months they will also be asked to complete a post evaluation survey about their knowledge and experiences throughout the study period.

Supporting GPs will be responsible for the referral and medical management of participants throughout the study period.
After their initial consultation and baseline measurements, the time commitment required by participants will be 3 visits to their GP (where bloodwork, blood pressure and measurements will be collected), completion of a set of questionnaires (taking no more than 15 minutes) and a 3 day food records (no more than ½ hour to complete) at 3, 6 and 12 months of the study period.

Intervention
This intervention requires the participants to follow the recommendations outlined in the Defeat Diabetes Application in order to make dietary and lifestyle changes over a 12-month period.
The Defeat Diabetes Application (DDA) is a subscription based commercial application for download on smartphone (Android and Apple OS). The DDA provides a guided educational program on specific low carbohydrate and lifestyle interventions to manage T2D.
On recruitment and receipt of the baseline reporting measures, participants will be given free lifetime access to the DDA. Defeat Diabetes will send an email link to participants with instructions explaining how to access and install the application. Participants will then be able to use the educational material provided at their convenience. All educational resources are time stamped so that users are aware of the level of detail and time required to complete each section.
The educational material and resources of the DDA consists of:
1. Structured video lessons and masterclasses
Lessons are structured to introduce and describe the main features of using a low carbohydrate diet and lifestyle changes for management of T2D and contain practical strategies for implementation. The 13 lessons vary in time from 6-13 minutes duration and require approximately 100 minutes to view the content in full. The 25 Masterclasses provide greater detail on selected topics and range in time from 3-13 minutes duration (approximately 180 minutes in total).
2. Articles
Short articles that address some common questions around nutrition and lifestyle such as meal planning and exercise recommendations, including work out plans with video instructions.
3. Low carbohydrates recipes and cooking demonstrations
Recipes and video demonstrations for breakfasts, lunch, dinner, drinks, snacks, sides and sweet treats are included. These are further separated into categories such as Dairy Free, Gluten Free, Keto, Vegetarian and seasonal categories.
4. Meal planning, shopping list and exercise plans
Detailed weekly plans for weekly meals utilising featured recipes and providing the facility of a shopping list to streamline meal preparation process. Also included are exercise and workout plans for multiple levels of fitness and abilities with videos elaborating on specific movement.
5. Access to an interactive private DDA Community Facebook group
Questions and answers can be posted and support provided during the transition to a low carbohydrate diet. Once a month real time events are also scheduled that typically consist of interviews or live Q&A sessions.
The research team will follow up participants at 2 weeks after recruitment via phone consultation to ensure that the there are no technical issues with using the DDA and that they have been able to access the private DDA Community Facebook group. Further follow up via email/or text messaging will occur in weeks 4 and 8 to answer/follow up any participant questions on DDA accessibility issues. Participants will be able to interact with the private DDA Community Facebook group (moderated by Defeat Diabetes) as required for additional support.

Intervention code [1]

Lifestyle

Comparator / control treatment

No control group,
Participants are referred to the study via their GP, The expectation is that pre- enrolment, participant GP management would be in line with the Royal Australian College of General Practitioners (RACGP) clinical guidelines for management of type 2 diabetes (Management of type 2 diabetes: A handbook for general practice).
It is stated in the inclusion criteria that the participants are to have type 2 diabetes and should not being using the Defeat Diabetes app OR using a low carbohydrate diet to manage their type 2 diabetes to be included in the study..

Control group

Uncontrolled

Outcomes

Primary outcome [1]

HbA1c assessed by blood test

Timepoint [1]

Baseline, 3, 6 and 12 months (primary timepoint) post-intervention commencement

Secondary outcome [1]

Insulin resistance (as measured by TRIG/HDL ratio, waist to height ratio) assessed by blood tests and anthropometry

Timepoint [1]

Baseline, 6 and 12 months post-intervention commencement

Secondary outcome [2]

Serum lipid biomarkers (TC, HDL-c, LDL-c, TRIG) assessed by blood test

Timepoint [2]

Baseline, 6 and 12 months post-intervention commencement

Secondary outcome [3]

Liver function (ALT, GGT) assessed by blood test. This is optional - and by discretion of GP who is collecting data at each time point.

Timepoint [3]

Baseline, 6 and 12 months post-intervention commencement

Secondary outcome [4]

Renal function (eGFR) assessed by blood test

Timepoint [4]

Baseline, 6 and 12 months post-intervention commencement

Secondary outcome [5]

Inflammation as measured by (CRP) OR (hs-CRP) assessed by blood test. This is optional - and by discretion of GP who is collecting data at each time point.

Timepoint [5]

Baseline, 6 and 12 months post-intervention commencement. This is optional - and by discretion of GP who is collecting data at each time point.

Secondary outcome [6]

Body weight, waist circumference, BMI, Waist to height ratio,
GPs will collect anthropometric data (stadiometer and scales available in GP practice setting)

Timepoint [6]