None listed
Conditions
Brief summary
AIM Metabolic and obesity surgery (MOS) is currently the most effective, durable strategy for weight management. Comprehensive outcome data following metabolic and obesity surgery is missing from the Australian bariatric population. This prospective long term cohort study aims to document and evaluate medical, psychosocial and behavioural factors linked to outcome measures. METHODS Recruitment will commence from April 2021 and continue until November 2023 or until 250 participants are recruited. The study will observe participants for 2 years with data collection commencing 1-2 months pre-MOS and at timepoints 3,6,12 and 24 months post-surgery. Participants include those undergoing surgery over 16 years of age, able to read and write English and give consent. All participants will receive usual care during the study period. Data collection will include demographics and family traits; medical history, mental health via the Depression, Anxiety and Stress Scale (DASS); Quality of Life via the Assessment of Quality of Life (AQoL-8D); dietary intake (via a dietitian assessment survey and a participant-completed food frequency questionnaire); dietary behaviour via the Eating Disorder Examination questionnaire (EDE-Q); social factors; weight stigma using the Weight Bias Stigmatisation Scale (WBIS); use of social support networks and beliefs using patient-completed surveys; and attendance at clinical appointments. The primary outcome of weight change will be reported in kilogram (kg) weight change, BMI (kg/m2) and percentage weight loss (%WL), secondary outcome measures will include health and psychosocial variables evaluated in the study. STATISTICAL ANALYSIS Descriptive statistics will be used to profile the baseline characteristics of the participants. Linear and generalised linear mixed models and survival models will be used for the longitudinal data analysis. The investigators plan to present and publish the findings of this study at scientific meetings, both nationally and internationally and in peer reviewed journals. Participants will be unidentifiable with results being anonymised. SUMMARY Obesity effects a third of Australians and MOS in Australia has become a popular tool for obesity management. This surgery is mainly performed in the private setting with minimal data available reporting on outcomes including that of health, psychosocial wellbeing, and dietary changes. This prospective observational study will add to the limited literature from the Australian setting, important real-world data on the long-term comprehensive outcomes following MOS. Results may assist clinicians in providing best practice individualised care.
Interventions
People undergoing metabolic and obesity surgery will be observed for 2 years following surgery and asked to complete a series of validated questionnaires prior to surgery and at 3,6,12 and 24 months following surgery. They will undergo care as usual. Questionnaires will be emailed to participants via a secure REDCap database. Outcomes to be reported on and evaluated include: demographics, anthropometry (weight change and BMI), medical conditions, mental health status using the DASS questionnaire
People undergoing metabolic and obesity surgery will be observed for 2 years following surgery and asked to complete a series of validated questionnaires prior to surgery and at 3,6,12 and 24 months following surgery. They will undergo care as usual. Questionnaires will be emailed to participants via a secure REDCap database. Outcomes to be reported on and evaluated include: demographics, anthropometry (weight change and BMI), medical conditions, mental health status using the DASS questionnaire and medical assessment, quality of life (QoL) using the AQoL-8D questionnaire, dietary intake using a dietitians assessment tool and disorder eating behaviour using the EDE-q tool, physical activity using the international Physical Activity Questionnaire (IPAQ), weight stigma using the Weight Bias Internalization Scale (WBIS), reflux using the GastroEsphogeal Reflux Disease (GERD) questionnaire, use of social networks, patient beliefs and attendance at clinical appointments will be recorded as part of usual care.
Sponsors
Dr Kathryn Williams
Eligibility
Sex/Gender
All
Age
16 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
To be included in this research, participants must meet these requirements: • Planning bariatric surgery • older than 16 years • able to understand the study protocol and/or give written consent to participate • agreeable to participate in all usual clinical data collection and to complete additional questionnaires, surveys and recording of usual food intake supplementary to normal clinical procedure • willing to allow the use of a translator or family member to assist in completion of these assessments and surveys, questionnaires and usual food intake records, if English is the second language, or if they have poor literacy levels.
Exclusion criteria
Younger than 16 years inability to understand and give consent
Outcome results
None listed