None listed
Conditions
Brief summary
Obesity is a major contributing factor in chronic disease burden within our community. While there are already established intervention management strategies for obesity, results on conventional primary care, non-invasive and/or drug-free approaches appear to be inconclusive. The planned study focuses on evaluating the efficacy of an already existing, peer-supported, behavioural change obesity intervention program, the “My Health for Life” (MH4L) program. The MH4L program is based around scheduled peer support sessions facilitated by a trained health or allied health professional. Participants in the intervention group also receive a MH4L workbook and printed material to assist with the behaviour change process. This is all in addition to their usual general practice care for weight management. This group will be compared with an active control where participants receive regular GP led management for obesity (6 month management plan designed by the participant’s regular GP which includes 5 visits to appropriate allied health services and 5 visits to chronic disease nurses as well as regular GP consultations as appropriate). All participants are tracked for 2 years after randomisation with measurements significant to obesity taken every 6 months. The study is a single blinded, randomised controlled trial. This means that there are two different treatment groups. One group is called the control group and they will receive currently established management for obesity. Another group is called the treatment group who will receive the new management program for obesity. Participants are not told what group they are assigned to (single blind) and group assignment is random. There is a 2 in 1 chance of being placed in the new treatment group. It is hoped that all participants in this study will, at a minimum, receive the best and most current medical management for obesity. However, the study will reveal the efficacy of a peer-supported obesity management program.
Interventions
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, chroni
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.
Sponsors
Inala Primary Care
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed