None listed
Conditions
Brief summary
Obesity is a relapsing chronic and complex condition with genetic, environmental, physiological, psychological, and behavioural determinants. Obesity is associated with significant comorbidities, particularly type 2 diabetes, cardiovascular disease, osteoarthritis, sleep apnoea and specific cancers. For people living with obesity and type 2 diabetes, the risks of diabetes-related complications adverse cardiovascular and musculoskeletal outcomes are increased. Managing obesity in people with type 2 diabetes through lifestyle modification, screening, and early detection of secondary complications can improve the management of diabetes-related complications. Evidence supports multidisciplinary person-centred approaches to providing obesity and diabetes care where individuals are active decision-makers in their healthcare. Nevertheless, while multidisciplinary management of people living with obesity and type 2 diabetes is the best-evidence practice, barriers to this level of support exist in rural, regional and remote areas. The development of the national guidelines was underpinned by a comprehensive systematic review of the literature (conducted by AI Shaw). This literature review identified important evidence gaps in the management of patients with diabetes mellitus who also have obesity (NHMRC, 2013). A number of these evidence gaps are the focus of this project. Diabetes services routinely focus on managing and treating diabetes, and obesity management are more of an afterthought. Furthermore, there is a greater prevalence of socioeconomically disadvantaged people living in rural, regional and remote areas and less access to services that support behaviour change when needed. This study aims to assess the feasibility and effectiveness of a rural, multidisciplinary model of obesity care personalised for adults living with type 2 diabetes mellitus and obesity. The research design is a randomised controlled clinical trial. The project will recruit 212 patients with diabetes and randomise them to active intervention or usual care. The active intervention group will receive an integrated, multidisciplinary model of care for obesity management devised in partnership with the person receiving the care and including multi-intervention as desired. In so doing, the participant can choose the care model that suits them best considering their circumstances.
Interventions
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.
Sponsors
Study design
Eligibility
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
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