Outcomes from a psycho-behavioural treatment for maintenance of weight loss.

The trial will be embedded in a large public hospital program at for people with moderate to severe obesity with medical complications, e.g. type 2 diabetes mellitus. This clinic provides a multidisciplinary medical and allied health review - dietetic, psychology, exercise physiology, physiotherapy. There is a mandatory intensive exercise program with on-site classes supervised by an exercise physiologist/physiotherapist. Medications and meal replacements are prescribed including weight neutral diabetes medications and a very low energy diet will occur regardless and in the year prior to the trial , if appropriate . Some are being prepared for a new publically funded bariatric program over a year. Assessments will be at • Time -12 (at entry into the clinic 12 months prior to Time 0), • Time 0 (baseline), • Time 2 (mid therapy), • Time 3 (end therapy), and • Time 4 (6-month follow-up). Recruitment will be facilitated by Senior clinicians at the clinic. Measures are parts of standard care and include anthropometry (body height and weight (calibrated scales) and waist circumference), pulse and sitting blood pressure, metabolic parameters, and the following validated self-report online instruments: • The Eating Disorder Examination-Questionnaire (EDE-QS) (Gideon et al., 2016) will assess eating disorder symptoms and behaviours such and binge eating. It has been validated against the gold standard full EDE-Q. • Role Performance will be asked using the question applied in the Australian national survey (Andrews et al., 2001) i.e. the number of days in the past month the person has not been able to perform usual activities either in the home or at work), • The Short-form 36 item version will be used to assess health related quality of life (HRQoL) in physical and mental health domains (Ware et al., 1992), • The Kessler 10-item questionnaire will be used assess psychological distress (depression and anxiety) (Kessler et al., 1992). A health care utilization survey designed to capture utilisation that may be related to the intervention and exclude irrelevant or random events such as infectious diseases and injuries will be administered. Health care utilisation will be translated into costs using average reimbursement rates. An independent assessor will also administer additional tests of cognitive function (problem solving/decision making – as used in our prior research (Raman et al., 2018)) and a qualitative appraisal of participant experience to inform further program development. Specific tests will include the: • Wisconsin Card Sorting Test – 64 item (WCST; Kongs, Thompson, Iverson, & Heaton, 2000) of set-switching. • The Iowa Gambling Task of Decision Making (Brogan, Hevey, & Pignatti, 2010; Bechara, 2007). • Serial 7 and Trail Making Task: Trail Making Test (TMT; Reitan & Wolfson, 1992) of sustained Attention & Speed of Information Processing. Intervention: HAPIFED-M will be delivered over a 4-month (16 weeks) period in groups meeting for 12 sessions weekly then fortnightly. A Clinical Psychologist will administer HAPIFED-M sessions. Each session will take 90 mins and address a psychoeducational topic and incorporate a cognitive remediation exercise to be practiced between sessions. These are designed to facilitate attention to detail and enhance and develop organization, planning and problem solving skills. Exercises include puzzles and tasks that facilitate attention to detail such as “Patterns” where people are asked to connect the dots and replicate a geometric figure and a task called “A Very Short Story,” where they read a short story and are asked to recount it in detail. Specific topics: 1. Re-visiting nutrition education and appetite regulation: Hungry and non-hungry eating 2. Loss of control eating, binge eating, grazing and bulimia. 3. Our social connections: Getting social support and improving social connections. 4. Navigating emotions: Mindfulness and relaxation 5. New moves: Activity and exercise 6. Other ways of thinking. Unhelpful thinking styles & what to do about them. 7. Food, events and moods: Changes in eating related to events and moods 8. Body talk and embracing diversity: Addressing dissatisfaction with body shape and weight. 9. When things don’t go as planned: Problem solving 10. A more confident you: Positive self-evaluation 11. Planning when treatment ends: Where to now? 12. An end and a beginning Group/peer support will be a key feature of the program as well as generic skills to build mental health and well-being. Specific skills will aid improved eating and nutrition such as training in problem solving, appetite regulation and hungry/non-hungry eating as well as reducing reliance on binge eating or other behaviours for mood regulation. Type of study (prospective study or involving access to data or data linkage as relevant) This is an open label uncontrolled trial testing the impact of a novel psycho-behavioural treatment, HAPIFED-M, on relapse prevention in people one-year after commencing multi-disciplinary weight loss program. Population/Sample size Participants are 60 adults, aged 18 years, who have achieved at least 5% weight loss after 12 months with the program. They will be recruited over a 1-year period after 12 month’s engagement with standard care (Time 0). Expected duration of study and start times The trial will start upon the grant of the Ethic’s approval. The trial endpoint for primary outcome is two years after presentation (Time -12) and the trial will thus run over 2 calendar years. Attendance checklist and weight measurment will be performed at each session by the RA.