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Trial registered on ANZCTR


Registration number
ACTRN12618000624280p
Ethics application status
Submitted, not yet approved
Date submitted
29/03/2018
Date registered
20/04/2018
Date last updated
2/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does a peer-supported lifestyle modification program improve health outcomes and satisfaction with care for obese patients.
Scientific title
Obesity care in the primary health setting: Does a peer-supported, nurse-facilitated lifestyle modification program (“My Health for Life”) lead to better health outcomes for obese patients and improved patient satisfaction with care?
Secondary ID [1] 294466 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 307227 0
Condition category
Condition code
Diet and Nutrition 306340 306340 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The MH4L program (intervention) consists of a single introductory one-on-one meeting with the program facilitator and 5 focus-group style sessions typically involving 5 to 8 participants per group and a MH4L-trained facilitator.

The one-on-one introductory meeting is for the purpose of introducing the MH4L course outline (expectations, program details and participant-facilitator obligations and roles), measure baseline data (weight, height, blood pressure, smoking and drinking statuses, chronic disease risks, exercise and dietary habits), understand participants’ demographics, answer questions and consent the patient for participation in the MH4L program (mandated by the program’s administrators). The meeting takes approximately 1 hour. Each participant is also given the MH4L course material which includes printed program manual, workbook, and program surveys (data collection under the program mandate and to assist the facilitator in their guidance of the sessions). After the introductory meeting, the participant enters group sessions (usually within 2 months). Each group session follows a set outline as prescribed by the workbook. Sessions 2 to 5 typically occur 2 weeks apart with session 5 and 6 being 12 weeks apart. Each group session covers different topics and runs for approximately 2 hours per session. Topics covered in sessions centre around goal setting and achievement, identifying personal barriers to lifestyle change, action planning, readiness to change, food choices, assessing successes and barriers and understanding the need to establish support networks. The sessions are topic discussions and the facilitator is present to answer questions, provide professional support, guide the discussions to roughly follow the prescribed course structure, administer the session survey and perform the required data collection tasks (for example weight, girth) which are performed in private. The whole program takes 6 months to complete. For specific details on the program, see www.myhealthforlife.com.au.

Facilitators utilise email, phone or text messaging as a way to remind patients of their upcoming sessions. From the experience of MH4L program administrators, Diabetes Australia Queensland (DAQ), focus group participants sometimes create their own social media pages to stay in touch with each other outside of the official program delivery model. This is neither discouraged nor within the control of the facilitator or MH4L administrators. Being a form of self-initiated social support, the creation of social media pages is viewed amiably by the MH4L program administrators. Should participants be concerned, they can raise the matter with the trained facilitator.

Adherence to the program is monitored at each session by the facilitator. This is done by logging attendance and completion of the survey at the end of each session. The survey covers topics related to adherence to interventional strategies but also to the participant’s successes, barriers, feelings and overall program satisfaction. The surveys also serve as a feedback tool for facilitators and allow them to alter the session structure to suit the group better. The MH4L program also informs the participant’s GP about their progress.

Facilitators for the My Health for Life program are trained in how to facilitate peer group sessions (see study protocol for further details). The facilitator training program is run by the MH4L program administrators (led by DAQ). It’s a face-to-face program which covers program content, delivery and behaviour change training. Prior to certification, the facilitator is assessed for their knowledge, understanding and general suitability to deliver the program. After training is complete, the facilitator must commence at least two separate MH4L support groups within 12 months. To remain as a certified facilitator, facilitators are required to attend an annual professional development day and run a minimum of two separate MH4L support groups per year. Prior medical or allied health qualifications are prerequisites for facilitators (example professions include exercise physiology, dietetics, aboriginal health work, nursing, occupational therapy, pharmacy, physiotherapy, etc.). At Inala Primary Care, the program is delivered by a registered nurse who has undergone and completed My Health for Life training. Hence, the intervention group for the study will be administered by a registered nurse (MH4L component) and also the patient’s regular GP at Inala Primary Care (IPC). Intervention fidelity is monitored by the program administrators via returned participant surveys. Overall study integrity (for example, monitoring for group cross-over) is monitored by the Clinical Director and research coordinator at IPC.

Participation in the intervention group is free to the participant. Incidental costs such as transportation to and from the focus group venue is not reimbursed.
Intervention code [1] 300759 0
Lifestyle
Intervention code [2] 300760 0
Behaviour
Comparator / control treatment
The active comparator (control) is regular GP-led obesity management following the current National Health and Medical Research Council (NHMRC) guidelines. All participants in the intervention arm also receive the active control.

The active control will be a GP management plan for chronic disease (obesity). The GP will tailor their management of the patient's obesity using the current NHMRC guidelines. As part of the management plan, the patient will visit their regular GP at the start of the management period to organise a plan and will also do a final visit at the end of the 12 month management plan period, As part of their management plan, Medicare funds 5 visits with a chronic disease nurse and 5 visits with any allied health professional required for obesity and their related comorbidities (for example a dietitian or exercise physiologist). This is what would be considered the current best practice for obese patients and such care is commonly available and established under Medicare's funding model.
Control group
Active

Outcomes
Primary outcome [1] 305359 0
Change in body weight using balance scale during a visit.
Timepoint [1] 305359 0
Baseline, months 6, 12, 18, 24, 30, 36 (endpoint).
Primary outcome [2] 305360 0
Change in waist circumference using a measuring tape during a visit.
Timepoint [2] 305360 0
Baseline, months 6, 12, 18, 24, 30, 36 (endpoint).
Primary outcome [3] 305361 0
Change in Body Mass Index utilising measures of weight (balance scale) and height (stadiometer) which are taken during a visit.
Timepoint [3] 305361 0
Baseline, months 6, 12, 18, 24, 30, 36 (endpoint).
Secondary outcome [1] 344948 0
Change in participants Australian Absolute Cardiovascular Disease risk score which is calculated using the NVDPA (National Vascular Disease Prevention Alliance) web-based calculator. See http://www.cvdcheck.org.au/ for more details.
Timepoint [1] 344948 0
Baseline. Months 6, 12, 18, 24, 30, 36.
Secondary outcome [2] 344949 0
Number of participants falling within the 'normal range' (less than 2mmol/L) for blood triglycerides concentration (measured using established methods at an approved Medicare-approved pathology laboratory).
Timepoint [2] 344949 0
Baseline, months 6, 12, 24, 36.
Secondary outcome [3] 344950 0
Number of participants with a healthy blood pressure of 120/80 to 139/89 mmHg as measured using either an electronic blood pressure monitor, aneroid (dial) or mercury sphygmomanometer (sitting position).
Timepoint [3] 344950 0
Baseline. Months 6, 12, 18, 24, 30, 36.
Secondary outcome [4] 344951 0
Patient satisfaction using the validated PSQ-18 (short form) survey.
Timepoint [4] 344951 0
6 months from the time of randomisation.
Secondary outcome [5] 345045 0
Change in participant's Australian Diabetes Risk score (AUSDRISK), maintained by the Australian Department of Health. See http://www.health.gov.au/internet/main/publishing.nsf/Content/chronic-diab-prev-aus for more details.
Timepoint [5] 345045 0
Baseline. Months 6, 12, 18, 24, 30, 36.
Secondary outcome [6] 345049 0
Number of participants falling in the 'normal range' (less than 1.8mmol/L for participants with CVD, diabetes or CKD, otherwise less than 2.5mmol/L) for blood low density lipoprotein cholesterol concentration (measured using established methods at an approved Medicare-approved pathology laboratory).
Timepoint [6] 345049 0
Baseline, months 6, 12, 24, 36.

Eligibility
Key inclusion criteria
1. Patients who are obese (BMI greater than or equal to 30)
2. Patients currently or choosing IPC as their regular primary care clinic
3. Able and willing to regularly attend only IPC for obesity management
4. Have any of the following: An AUSDRISK score greater than or equal to 12, an Australian Absolute Cardiovascular Risk score of greater than or equal to 15%, blood pressure of greater than 159 systolic or 99 diastolic, or any of Inclusion Criteria 5c.
5. Age:
5a. 18 years or above for ATSI patients or
5b. 45 years or above for all other ethnicities or
5c. 18 years or above for obese patients diagnosed with any of the following:
5c(i). Familial hypercholesterolemia
5c(ii). High cholesterol (on medication)
5c(iii). Previous gestational diabetes mellitus.
5c(iv). Blood pressure of greater or equal to 140/90 in 3 separate readings recorded by their GP.
6. English speaking and literate
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Doesn’t meet the inclusion criteria or cannot receive Medicare benefits.
2. Have uncontrolled or poorly managed diabetes mellitus type 1 or 2.
3. Have severe heart disease.
4. Have uncontrolled or severe chronic kidney disease (stage 3b or higher).
5. Already receiving care for obesity elsewhere or have been part of a structured obesity management program within the past 12 months, including the taking of any prescription medication for obesity.
6. Started any medication known to temporarily alter weight in the past 6 months, for example, metformin or empagliflozin.
7. Are currently experiencing an unexplained weight loss.
8. Have chosen to be managed at another GP practice for their obesity.
9. Have been pregnant in the last 6 months or are currently pregnant or planning to become pregnant in the next 24 months.

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)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized random sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size
An obesity intervention study by Wadden et al (2011) demonstrated a mean weight change of ˜5.8 kg (˜5.2%) between their most intensive intervention and control groups (8). The pooled standard deviation was 17.2 kg. Diabetes Australia suggests a 5-10% weight reduction significantly reduces the risk of diabetes mellitus type 2 (9). Assuming we use a one-tailed t-test for difference between two independent populations, maintaining 80% power (1-ß), with a at 0.05 and an effect size calculated using data from Wadden et al (2011), randomisation of 2:1 in favour of the intervention and a 10% drop out rate, a sample size of 320 participants (107 participants for the control arm and 213 for the treatment arm) would be required. However, this number of participants may not be achievable based on patient base of IPC. A compromise analysis with ß:a = 1 using the same effect size found that a total of 150 participants (50 in the control arm and 100 in the treatment arm) would produce a power of 80%, assuming 10% drop out. Overall, a smaller sample size would reduce the significance of time-to-adverse event analysis, but would still allow for reasonable comparison of means and also allow us to perform qualitative analyses without much detriment to study significance. Sample size is not a critical aspect of qualitative thematic analysis; reliability and quality of responses are.

Data Analysis
Intention to treat analysis will be employed. Several methods will be used as the data types differ:
• Time-to-adverse event: Cox model
• Non-normally distributed data and non-parametric data: Wilcoxon signed ranked test
• Normally distributed data: T-test
• Comparing proportions or associations (if required): Chi-squared test and/or Pearson correlation
• Interview/Focus Group responses: Qualitative thematic analysis
Microsoft Excel, R and Minitab will be used for statistical analysis.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Other reasons/comments
Other reasons
Change in study focus and lack of resources at planned site. Both have changed the protocol significantly and this provisional registration will no longer be accurate.
Date of first participant enrolment
Anticipated
2/08/2018
Actual
Date of last participant enrolment
Anticipated
2/09/2019
Actual
Date of last data collection
Anticipated
2/09/2022
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 22237 0
4077 - Inala

Funding & Sponsors
Funding source category [1] 299089 0
Charities/Societies/Foundations
Name [1] 299089 0
Inala Primary Care Limited
Country [1] 299089 0
Australia
Funding source category [2] 299152 0
Government body
Name [2] 299152 0
Medicare Australia
Country [2] 299152 0
Australia
Funding source category [3] 299153 0
Charities/Societies/Foundations
Name [3] 299153 0
Diabetes (Australia) Queensland
Country [3] 299153 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Inala Primary Care
Address
64 Wirraway Parade
Inala, QLD, 4077
Country
Australia
Secondary sponsor category [1] 298340 0
None
Name [1] 298340 0
Address [1] 298340 0
Country [1] 298340 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300026 0
University of Queensland Human Research Ethics Committee (A/B)
Ethics committee address [1] 300026 0
Ethics committee country [1] 300026 0
Australia
Date submitted for ethics approval [1] 300026 0
27/04/2018
Approval date [1] 300026 0
Ethics approval number [1] 300026 0

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

Contacts
Principal investigator
Name 82302 0
Dr Suzanne Williams
Address 82302 0
Inala Primary Care
64 Wirraway Parade
Inala, QLD, 4077
Country 82302 0
Australia
Phone 82302 0
+61732755444
Fax 82302 0
+61732789987
Email 82302 0
swilliams@inalaprimarycare.com.au
Contact person for public queries
Name 82303 0
Tracey Johnson
Address 82303 0
Inala Primary Care
64 Wirraway Parade
Inala, QLD, 4077
Country 82303 0
Australia
Phone 82303 0
+61732755444
Fax 82303 0
+61732789987
Email 82303 0
tjohnson@inalaprimarycare.com.au
Contact person for scientific queries
Name 82304 0
David Chua
Address 82304 0
Inala Primary Care
64 Wirraway Parade
Inala, QLD, 4077
Country 82304 0
Australia
Phone 82304 0
+61732755444
Fax 82304 0
+61732789987
Email 82304 0
dchua@inalaprimarycare.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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