Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000240741
Ethics application status
Approved
Date submitted
27/01/2022
Date registered
10/02/2022
Date last updated
10/02/2022
Date data sharing statement initially provided
10/02/2022
Date results provided
10/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Assessment and Management of Obesity and Self maintenance (AMOS) Clinic Evaluation
Scientific title
The Assessment and Management of Obesity and Self maintenance (AMOS) Clinic:
Implementation and Evaluation of the AMOS Model of Care in adults with type 2 diabetes and obesity
Secondary ID [1] 306083 0
Nil known
Universal Trial Number (UTN)
Trial acronym
AMOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 324743 0
Diabetes 324744 0
Condition category
Condition code
Metabolic and Endocrine 322195 322195 0 0
Diabetes
Diet and Nutrition 322526 322526 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individualised multidisciplinary multi-intervention assessment and treatment of obesity management. The focus was to provide the person living with obesity and type 2 diabetes support to enable informed, individualised strategies to support sustained weight loss.

On attending the AMOS Clinic (intervention) at the Diabetes Centre at the Tasmanian Health Service the participant will be offered the following:
1. A 30-minute face-to-face pre-assessment by a Credentialled Diabetes Educator ( a nurse specialising in diabetes with 5-years’ experience as a health professional) including:
a. Physical measurements (BMI, BP, girth, weight) and HbA1c.
b. Universal screening for depression, anxiety, sleep apnoea, cardiovascular to support
planned assessment and care:
• Psychometric scales (Patient Health Questionnaire (PHQ-9), Generalised Anxiety
Disorder (GAD-7), Health Survey Short Form (SF-36v2), Assessment of Quality of
Life (AQoL) and Work Productivity and Activity Impairment (WPAI)
• Epworth Sleepiness Scale
• Absolute cardiovascular risk
• Edmonton Obesity Staging
2. A 45-mintue face-to-face pre-assessment by a senior physiotherapist with a minimum 3-years’ experience as a health professional including:
a. Assessment for physical functioning performed
b. Completion of McCaffery Pain Assessment scale
3. Two to four weeks later participants are then seen in the AMOS clinic by the dietitian for 30-minutes and nurse practitioner for 30-minutes face-to-face at baseline, six and 12-weeks and then three-monthly for assessment and management, and the physiotherapist at baseline and six weeks and 6-monthly for development of an exercise prescription and assessment.
a. According to dietitian assessment participant seen 1:1 for a 60-mintue face-to-face
consultation or booked into a 90-minute group program involving maximum of four
participants facilitated by a psychologist and dietitian with focus on identification of
barriers to weight loss and healthy eating.
b. Nurse practitioner assessment includes:
i. a review of participants obesity and diabetes management.
ii. screening for metabolic pathology (HbA1c, lipids, vitamin B12 and folates, TFTs,
LFTs, ACR, eGFR and leptin, ketones and vitamin D.
c. Physiotherapist face-to-face assessment at the clinic includes:
i. Completion of McCaffery Pain assessment scale
ii. Completion of a full physical functioning and balance assessment [6-minute walk test
(6MWT), Timed Up and Go (TUG), 30-second Chair Stand test (30s-CST), falls risk]
iii. Exercise prescription included a home exercise program of low to moderate intensity
dependent on cardiac function and medical clearance including walking, hydrotherapy,
resistance and strengthening exercises with resistance band to be performed 5 times
per week.
iv. Assessment was completed by reassessing markers from point (ii) and adherence
measured by verbal confirmation at each consultation with the following scale:
- Sedentary (no planned activity)
- Less than 120 minutes/week (minimal)
- Up to 150 minutes/week (moderate)
- Greater than 150 minutes/week (recommended)
d. Treatment plan devised in partnership with participant, nurse practitioner and dietitian
and includes:
i. Agreed weight loss goals.
ii. Referral as relevant to:
o Other health professional/specialist (sleep apnoea or pain management
assessment if applicable)
o Community Based Weight /Pain management programs (Stanford – Get The Most
Out Of Life program and Overcoming Pain And Living Well program [OPAL]).
o When a moderate or high score is confirmed on psychometric scales (PHQ-9 and
GAD-7) the participant is triaged and offered an appointment with the
psychologist.
iii. Resistant or balance training.
iv. Medicines alteration and/or titration in alignment with caloric intake reduction.
v. Behaviours Modification and Self-Maintenance awareness
4. Participants will also receive a 10-minute phone call at weeks 2, 4, 8 and 10 by a credentialled diabetes educator allocated to the clinic to confirm instructions were understood, assess medication side effects and progress.
5. Initiation of Orlistat if BMI > 35 and < 2% weight loss after 3 months.
6. Referral for bariatric assessment if deemed suitable and after 12 months failed treatment and <5% weight loss.
Intervention code [1] 322726 0
Treatment: Other
Intervention code [2] 322727 0
Lifestyle
Comparator / control treatment
The comparator was routine care provided to participants attending the Diabetes Centre at the Tasmanian Health Service. Routine care traditionally includes a pre-clinic assessment by a nurse to collect physical measurements including BMI, BP, weight and HbA1c.
Then a 20-mintue assessment by an endocrinologist focused on diabetes management.
Screening primarily includes HbA1c, lipids, vitamin, B12 and folates, TFTs, LFTs, ACR and eGFR.
Control participants involved in routine care may be referred to a credentialled diabetes educator as needed for ongoing education about diabetes management if their HbA1c is above target.
Control participants involved in routine care may be referred to the dietitian if HbA1c > 9% in type 2 diabetes.
Care may include adhoc referral for bariatric assessment if BMI >40 and failed attempts at weight loss without any preparation.
Control group
Active

Outcomes
Primary outcome [1] 330277 0
What is the average change in HbA1c from a blood sample (measured as a continuous variable) in the intervention group compared with the control group?
Timepoint [1] 330277 0
Average HbA1c after 6-months post base-line (primary timepoint).
Average change in HbA1c results will also be reviewed at 12, 18 and 24-months post baseline; also 6 and 12-months post intervention
Primary outcome [2] 330278 0
What is the average change in body weight on digital scales (measured as a continuous variable) in the intervention group compared with the control group?
Timepoint [2] 330278 0
Average weight loss after 6-months post-baseline (primary timepoint).
Average weight loss results will also be reviewed at 12, 18 and 24-months post baseline; also 6 and 12-months post intervention.
Secondary outcome [1] 405548 0
Change in Edmonton Obesity Status grading
Timepoint [1] 405548 0
At 12 and 24 months post baseline; also 12 months post intervention
Secondary outcome [2] 405550 0
Proportion of participants achieving individualised HbA1c targets according to the Australian Diabetes Society guideline by auditing primary outcome HbA1c > or < 7%.
Timepoint [2] 405550 0
At 12 and 24 months post baseline; also 12 months post intervention
Secondary outcome [3] 405551 0
Change in quality of life using the Assessment of Quality of Life (SF-36) assessment form.
Timepoint [3] 405551 0
At 6, 12, 18 and 24 months post baseline; also 6 and 12 months post intervention
Secondary outcome [4] 405785 0
Change in level of depression using the Patient Health Questionnaire (PHQ-9) [Depression] scale
Timepoint [4] 405785 0
At 6, 12, 18 and 24 months post baseline; also 6 and 12 months post intervention
Secondary outcome [5] 405786 0
Change in anxiety level using the Generalised Anxiety Disorder Assessment (GAD-7) tool,
Timepoint [5] 405786 0
At 6, 12, 18 and 24 months post baseline; also 6 and 12 months post intervention
Secondary outcome [6] 405787 0
Change in quality of life using the Assessment of Quality of Life (AQoL) tool
Timepoint [6] 405787 0
At 6, 12, 18 and 24 months post baseline; also 6 and 12 months post intervention
Secondary outcome [7] 405789 0
Change in work productivity using the Work Productivity and Activity Impairment (WPAI) tool.
Timepoint [7] 405789 0
At 6, 12, 18 and 24 months post baseline; also 6 and 12 months post intervention
Secondary outcome [8] 405794 0
Change in Body Mass Index using the body mass determined by digital scales divided by the square of the body height determined by stadiometer and expressed in units of kg/m2,
Timepoint [8] 405794 0
At 6, 12, 18 and 24 months post baseline; also 6 and 12 months post intervention
Secondary outcome [9] 405795 0
Change in absolute cardiovascular risk by using the cardiovascular risk calculator http://www.cvdcheck.org.au/
Timepoint [9] 405795 0
At 12 and 24 months post baseline; also 12 months post intervention
Secondary outcome [10] 405923 0
Change in estimated Glomerular Filtration Rate (eGFR) calculated from blood test results using the formula mLs/min/1.73m2
Timepoint [10] 405923 0
At 6, 12, 18 and 24 months post baseline; also 6 and 12 months post intervention

Eligibility
Key inclusion criteria
Person living with type 2 diabetes and with a BMI equal to or greater than 30
Person already in the care of the Diabetes Centre, Tasmanian Health Service (North West)
Able to provide informed consent
Not pregnant or breastfeeding
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Person living with type 2 diabetes and with a BMI less than 30
Person living with type 1 diabetes
Person living with diabetes and aged 75 years of age or greater or less than 18 years of age
Any pregnant or breastfeeding person with diabetes
Any person with a cognitive impairment, an intellectual disability or uncontrolled psychotic illness

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation
• All patients referred to the Diabetes Centre are currently listed in the services clinical software program DiaBASE.
• The list of potential participants was drawn from this program (that is inclusive of all patients) as at 10/9/2014.
• Once those that met the exclusion criteria were removed this list of potential participants
will be ranked from highest to lowest BMI and allocated a study number. Number one being the highest BMI.
• Numbers were assigned for the two arms of the study from the computer random number generated via excel.
• According to numbers allocated to the potential participant list these are then assigned to the two arms of the study (intervention and control).
• The participant then either continue to attend routine diabetes clinics as usual or are allocated to the AMOS clinic according to this randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by Microsoft Excel computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cross contamination is managed by several means:
- The clinics are run on alternate days ~ thus patients are unlikely to come across each other ~ they may within the community as they would with any other RCT
- The interventions which include multidisciplinary assessment and care, the use of orlistat
and potentially bariatric surgery if identified as a suitable candidate requires assessment
and referral – the control group patients will not have the assessments performed
routinely and/or be in the setting to have these referrals created
- The intervention group utilises a different credentialled diabetes educator than the ones
used in the traditional (usual care) diabetes clinic
- The endocrinologist involved in this study will mainly be involved in the AMOS clinic –
during other clinics he will be seeing patients with type 1 diabetes of lower BMI who do
not meet the criteria and due to different disease process their needs will differ
- An alternate endocrinologist not involved in AMOS will see the control group within the
traditional (usual care) diabetes clinic
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size of 212 participants (randomising 106 participants to each group) was
calculated by performing power calculations assuming significant differences between
intervention and control groups in one or more of the following measures:
- HbA1c
- Absolute cardiovascular risk
- Psychometric measures (PHQ-9, depression and SF-36 Quality of Life)
- Decline in Edmonton Obesity status

Data will be exported from DiaBASE (Clinical software program) and entered into Excel
(Microsoft) for data cleaning, Then it will be imported into Stata 12 and SPSS for analysis.
~ Analysis will be performed using SPSS and Stata.
~ Descriptive statistics will first be calculated to investigate the proportions of categorical
variables and the distribution of continuous variables.
~ Pearson’s chi-square test or Fisher’s exact tests will be utilized for investigation of associations between categorical variables, while independent t-tests will be used to investigate differences in continuous data between the control and intervention groups.
~ For dichotomous outcomes logistic regression will be performed.
~ For continuous outcome data analysis of covariance will be performed to test the effects of predictor variables.
~ Adjusted relative risks (aRR) of metabolic and psychometric outcomes will be calculated for the control vs. intervention groups (with 95% confidence intervals) using a Poisson regression model with robust error variance.
~The regression models will include adjustment for age, pre-existing diabetes, socio-economic status and Asian or indigenous ethnicity.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/02/2015
Date of last participant enrolment
Anticipated
Actual
12/06/2016
Date of last data collection
Anticipated
Actual
1/12/2019
Sample size
Target
212
Accrual to date
Final
224
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 21571 0
North West Regional Hospital - Burnie
Recruitment postcode(s) [1] 36491 0
7320 - Burnie

Funding & Sponsors
Funding source category [1] 310425 0
Government body
Name [1] 310425 0
Department of Health and Human Services: National Partnership Agreement – Tasmanian Assistance Package grant
Country [1] 310425 0
Australia
Primary sponsor type
Hospital
Name
North West Regional Hospital
Address
23 Brickport Road
Burnie, Tasmania 7320
Country
Australia
Secondary sponsor category [1] 311854 0
None
Name [1] 311854 0
Address [1] 311854 0
Country [1] 311854 0
Other collaborator category [1] 282142 0
University
Name [1] 282142 0
Menzies Institute for Medical Research
Address [1] 282142 0
Medical Science Precinct
17 Liverpool Street
Hobart TAS 7000
Country [1] 282142 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310064 0
Health and Medical Human Research Ethics Committee
Ethics committee address [1] 310064 0
Ethics committee country [1] 310064 0
Australia
Date submitted for ethics approval [1] 310064 0
01/09/2014
Approval date [1] 310064 0
01/12/2014
Ethics approval number [1] 310064 0
H0014324

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116366 0
Dr Giuliana Murfet
Address 116366 0
Diabetes Centre
North West Regional Hospital
Tasmanian Health Service - North West
P.O. Box 258
Burnie
Tasmania, 7320
Country 116366 0
Australia
Phone 116366 0
+61 0419568176
Fax 116366 0
Email 116366 0
[email protected]
Contact person for public queries
Name 116367 0
Giuliana Murfet
Address 116367 0
Diabetes Centre
North West Regional Hospital
Tasmanian Health Service - North West
P.O. Box 258
Burnie
Tasmania, 7320
Country 116367 0
Australia
Phone 116367 0
+61 0419568176
Fax 116367 0
Email 116367 0
[email protected]
Contact person for scientific queries
Name 116368 0
Giuliana Murfet
Address 116368 0
Diabetes Centre
North West Regional Hospital
Tasmanian Health Service - North West
P.O. Box 258
Burnie
Tasmania, 7320
Country 116368 0
Australia
Phone 116368 0
+61 0419568176
Fax 116368 0
Email 116368 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?
Individual participant data (IPD), i.e. de-identified raw line-by-line data collected from each participant will be shared: weight, BMI, BP, girth, HbA1c, lipids, vitamin B12 & folates, TFTs, LFTs, ACR, eGFR, vitamin D, fasting leptin, ketones. Also, PHQ-9, GAD-7, SF-36, AQoL, WPAI, McCaffery pain & Epworth Sleepiness scores, medical conditions and date of death.

When will data be available (start and end dates)?
Mid-2019 to mid-2022
Two unexpected delays occurred during the data analysis period due to illness and COVID.
Available to whom?
Dr Michelle Kilpatrick - Research Fellow and Biostatistician at Menzies Institute for Medical Research.
Dr Iain Robertson - Biostatistician at Clifford Craig Foundation
Available for what types of analyses?
Descriptive statistics, Pearson’s chi-square test or Fisher’s exact tests, independent t-tests, logistic regression, covariance, adjusted relative risk, and regression models.
How or where can data be obtained?
Access to pooled data subject to approvals by Principal Investigator - Dr Giuliana Murfet ([email protected])


What supporting documents are/will be available?




Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.