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Trial registered on ANZCTR


Registration number
ACTRN12622001530718
Ethics application status
Not required
Date submitted
29/11/2022
Date registered
12/12/2022
Date last updated
12/12/2022
Date data sharing statement initially provided
12/12/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Group versus Individual Education for Diabetes Control in Obese Adults.
Scientific title
A parallel group pilot randomised controlled trial testing the effect of Group versus Individual Education on Diabetes Distress in Obese (BMI>35kg/m2) Adults with requiring Insulin for Type 2 Diabetes Mellitus.
Secondary ID [1] 308518 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 328343 0
Obesity 328344 0
Condition category
Condition code
Metabolic and Endocrine 325381 325381 0 0
Diabetes
Diet and Nutrition 325431 325431 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following general practice referral to the Metabolic and Weight Loss Clinic eligible patients are invited to participate in a program of education titled 'Healthy with Diabetes'. The program is comprised of six modules, delivered over 6 weeks. Each module is delivered weekly in a one hour time slot with 35 to 40 minutes of content and 20 to 25 minutes of additional time for discussion. The modules are provided face-to-face or via Telehealth, with a focus on a motivational education content delivery. The program of delivery follows a systematic design and complete modules are completed in order in sequenced order. In the intervention group, patients participate in group based education delivery. If a week/module is missed participants are re-scheduled into the next available module session. As such, group size can vary from between 6 to 10 participants in any given session. Session attendance and module completion are monitored and recorded for each participant to ensure program completion, which is a pre-requisite for additional treatment referral pathways offered by the clinic.
The Week 1 module addresses endogenous Insulin and how it works in the context of homeostasis. Week 2 is focused on the practical aspects of monitoring blood glucose levels, achieving glucose targets and how blood glucose can influence appetite, mood and body function. Week 3 unpacks causes of type 2 diabetes mellitus, body changes associated with this condition and global changes that impact on maintaining a healthy lifestyle. Week 4 content relates to changes in diabetes as people get older, the need for additional care in periods of illness and self-management using the 'Annual Cycle of Care' checklist and 'Sick Day Management' strategies developed by Diabetes Australia. Week 5 focuses on the impact reducing Insulin resistance can have on health and well-being and Week 6 addresses being medication wise including reading medication labels, understanding medications taken for diabetes, medication side effects and how these medications influence weight.
Intervention code [1] 324956 0
Lifestyle
Intervention code [2] 325002 0
Behaviour
Comparator / control treatment
In the control group, individual participants complete the same program of education titled 'Healthy with Diabetes', over the same time frame, in the same sequence, via the same mode of delivery, one-one-one. Session attendance and module completion are monitored and recorded for each participant to ensure program completion, which is a pre-requisite for additional treatment referral pathways offered by the clinic.
Control group
Active

Outcomes
Primary outcome [1] 333237 0
Diabetes distress measured using the Diabetes Distress Scale
Timepoint [1] 333237 0
12 months post program commencement
Secondary outcome [1] 416301 0
Depression & Anxiety measured using the DASS-21
Timepoint [1] 416301 0
12 months post program commencement
Secondary outcome [2] 416508 0
Epworth Sleepiness Scale
Timepoint [2] 416508 0
12 months post program commencement
Secondary outcome [3] 416509 0
Quality of Life using the EQ-5D-5L
Timepoint [3] 416509 0
12 months post program commencement
Secondary outcome [4] 416510 0
Quality of Life using the SF36
Timepoint [4] 416510 0
12 months post program commencement
Secondary outcome [5] 416511 0
BMI kg/m2 measured using an electronic stadiometer and a Wedderburn® medical bed scale. Participants ambulate onto the bed scale ramp to be weighed.
Timepoint [5] 416511 0
12 months post program commencement
Secondary outcome [6] 416512 0
HbA1c measured with routine blood tests
Timepoint [6] 416512 0
12 months post program commencement
Secondary outcome [7] 416513 0
Blood Pressure measured using a manual sphygmomanometer and bariatric cuff
Timepoint [7] 416513 0
12 months post program commencement
Secondary outcome [8] 416514 0
Insulin Dose as reported by participants
Timepoint [8] 416514 0
12 months post program commencement

Eligibility
Key inclusion criteria
Patients will be eligible for inclusion if they have a BMI >35 kg/m2, and a HbA1c >9%, or are an insulin-requiring type 2 diabetic on > 1U/kg/day.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include BMI <35 kg/m2, and a HbA1c <9%, non insulin-requiring type 2 diabetic, current smoker not willing to commence treatment to quit smoking, pregnant.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation was via computer allocation that involved contacting the holder of the allocation schedule who was "off-site"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This was a pilot study to establish intervention feasibility and estimate sample size requirements to test intervention efficacy.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We could not find a study that reported effect size associated with education interventions, specifically for morbidly obese diabetic patients. We hypothesised that group based education would lessen the mean level of diabetes distress by a clinically meaningful increment of 1.0 in the diabetes distress scale (DDS) in our MIMO (metabolic disease, inflammation, microbiome and obesity) cohort. To detect a mean difference of 0.75 in total DDS score, with 80% power and a p value of 0.05 we needed a total of 46 patients, 23 in each group.
Data will be exported from REDCap into IBM SPSS Statistics (Version 28.0) for analysis. On the completion of data screening for inconsistencies or errors non-identifiable data will be analysed using descriptive and inferential statistics. Categorical data will be presented as frequency with proportion and continuous data as mean with standard deviation when normally distributed or median with quartiles. Baseline data and 12 month outcomes will be compared according to mode of educational delivery. Categorical variables will be analysed using chi-square or two-tailed Fisher’s exact test with appropriate degrees of freedom to test for equality of proportions. Independent samples t-tests (two-tailed) will be used to test for equality of means of continuous variables or the non-parametric equivalent Kruskal-Wallis test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/02/2020
Date of last participant enrolment
Anticipated
Actual
9/06/2021
Date of last data collection
Anticipated
Actual
9/12/2022
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23653 0
Blacktown Hospital - Blacktown
Recruitment postcode(s) [1] 39073 0
2148 - Blacktown

Funding & Sponsors
Funding source category [1] 312757 0
Hospital
Name [1] 312757 0
Blacktown Hospital
Country [1] 312757 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
Research & Education Network
Westmead Hospital
Darcy Road
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 314442 0
None
Name [1] 314442 0
Address [1] 314442 0
Country [1] 314442 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 312059 0
WSLHD HREC
Ethics committee address [1] 312059 0
WSLHD
Research & Education Network
Westmead Hospital
Darcy Road
Westmead NSW 2145
Ethics committee country [1] 312059 0
Australia
Date submitted for ethics approval [1] 312059 0
Approval date [1] 312059 0
Ethics approval number [1] 312059 0

Summary
Brief summary
National statistics from Australian sources predict normal-weight adults will comprise less than one third of the population by 2025. Evidence suggests there are synergies between obesity and type 2 diabetes mellitus (T2D). Insulin resistance is common in patients with obesity and results in a 7-12 fold increase in the risk of developing T2D.
It is not unusual for patients attending the Metabolic and Weight Loss Program at our hospital to have large daily doses of insulin to manage their T2D. These patients often report fatigue, poorly controlled diabetes and difficulty managing their blood glucose level. Evidence from patients indicates lifestyle changes, psychosocial issues, insulin side-effects, dietary perceptions and a lack of confidence in diabetes self-care also influences blood glucose management. Evidence focused on support networks or education programs to improve self-management of T2D for obese patients is difficult to locate. The aim of this study was to determine whether group based education led to a reduction in diabetes distress when compared to usual care.
Trial website
Trial related presentations / publications
Public notes
This study was a nested sub-study of the MIMO (Metabolic disease, Inflammation, Microbiome & Obesity) study. The MIMO protocol includes the Healthy with Diabetes' lifestyle education program that can be delivered to individual participants by the Credentialed Diabetic Nurse Educator in a one-on-one or group session. On occasion session modules were delivered to more than one participant at a time which was well received by participants who perceived that the group discussion generated using this approach improved their learning, which provided the impetus for the trial. Advice from the Western Sydney Local Health District Human Research Ethics Committee (HREC) was that a separate ethics approval was not required in the context of ongoing MIMO monitoring under the auspices of the existing MIMO HREC approval.

Contacts
Principal investigator
Name 123314 0
Prof Rochelle Wynne
Address 123314 0
The Royal Melbourne Hospital
Grattan Street
Parkville VIC 3010
Country 123314 0
Australia
Phone 123314 0
+61 407822988
Fax 123314 0
Email 123314 0
[email protected]
Contact person for public queries
Name 123315 0
Annette McDonald
Address 123315 0
Teamleader
Blacktown Metabolic & Weight Loss Program
Blacktown Hospital
18 Blacktown Rd
Blacktown NSW 2148
Country 123315 0
Australia
Phone 123315 0
+61 418132128
Fax 123315 0
+61 2 98516006
Email 123315 0
[email protected]
Contact person for scientific queries
Name 123316 0
Rochelle Wynne
Address 123316 0
The Royal Melbourne Hospital
Grattan Street
Parkville VIC 3010
Country 123316 0
Australia
Phone 123316 0
+61 407822988
Fax 123316 0
Email 123316 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the de-identified individual participant data collected during the trial will be available on request following publication of the trial results
When will data be available (start and end dates)?
We anticipate completion of follow-up in early December 2022, submission of a manuscript in February 2023 and publication of results in a peer reviewed journal mid 2023. The data will be available for a minimum of 5 years following the final publication or presentation associated with the longitudinal cohort study MIMO.
Available to whom?
Data will be available to researchers who provide a methodologically sound proposal. Each request will be considered on a case by case basis
Available for what types of analyses?
Data will be available to achieve the aims in the approved proposal
How or where can data be obtained?
Access to data will be subject to approvals by the Principal Investigator Prof Rochelle Wynne who can be reached via [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17734Study protocol  [email protected] Via the Principle Investigator



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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