The Impact of Combined Nutritional-Behavioural Tele-Counselling and Supervised Exercise Intervention on Weight Loss and Health Outcomes Following Bariatric Surgery (BARI-LIFESTYLE): A Single-Blind, Parallel-Group, Randomised Controlled Trial Embedded within an Observational Cohort Study

• DOI: 10.2139/ssrn.4257627
• Publication Date: 2022-12-28T11:24:47Z
• Authors: Friedrich C. Jassil; Alisia Carnemolla; Helen Kingett; Jacqueline Doyle; Amy Kirk; Neville Lewis; Gemma Montagut; Parastou Marvasti; David Boniface; Adrian Brown; Kusuma Chaiyasoot; Roxanna Zakeri; Jessica Mok; Kalpana Devalia; Chetan Parmar; Rachel Batterham
• Keywords: Single blind

Background: Bariatric surgery is the most effective weight loss treatment for people living with severe obesity. However, following surgery, and health benefits vary markedly between individuals, ability to adapt post-operative lifestyle changes implicated as a potential mediator. The BARI-LIFESTYLE trial investigated whether 12-month adjunctive post-surgery intervention programme compared usual standard care impacted upon outcomes.Methods: This single-blind, parallel-group, randomised controlled embedded within an observational cohort study was carried out in three National Health Service bariatric centres London, UK. Adults aged 18 65 years who underwent either primary gastric bypass or sleeve gastrectomy met eligibility criteria were recruited study. On day of participants (1:1) receive consisted 17 nutritional-behavioural tele-counselling sessions once-weekly tailored supervised exercise commenced at 3-months which 12-week duration. Both groups received care, stipulated by Institute Care Excellence (NICE) guidelines. outcome percentage (%WL) 6-months versus control groups. Our analysis based on intention-to-treat principle. Key secondary outcomes included body composition, physical activity levels, function strength, health-related quality life (HRQoL), depressive symptomatology comorbidities. registered ClinicalTrial.gov, NCT03214471.Findings: Between Feb 21, 2018, Nov 13, 2019, 514 patients undergoing assessed eligibility. Of these, 79 randomly assigned group 74 group. A total 104 (49 55 group) analysis. Longitudinal entire showed significant reductions over time weight, fat mass, fat-free bone mineral density (BMD) hip, femoral neck lumbar spine (all p<0·001). Furthermore, 6-minute walk test, sit-to-stand HRQoL improved significantly spent moderate-to-vigorous (MVPA) sedentary behaviour remained same pre-surgery (both p>0·05). that no difference %WL (20·0% 21·2%; mean difference=-1·2%; 95% CI, -3·5 1·1; No between-group differences observed other outcomes.Interpretation: Following mass reduced, whilst function, improved. BMD decreased there improvement MVPA behaviour. An first 12 months had additional impact favourable effect outcomes.Trial Registration Details: NCT03214471.Funding Information: Research (NIHR) (RP-2015-06-005), Sir Jules Thorn Charitable Trust (16JTA), Rosetrees (M641).Declaration Interests: RLB reports research grants from Research, Trust. Outside submitted work, personal fees Novo Nordisk, ViiV Healthcare Ltd, Pfizer, Gila Therapeutics Inc., Eli-Lilly International Medical Press. also unpaid roles Royal College Physicians, Association Study Obesity, British Obesity Metabolic Surgery Society, Registry, Federation Disorders, European Society Endocrinology, Empowerment Network UK Excellence. AB support grant Novo-Nordisk; honoraria Public England, UK; Advisory Board shareholder Reset Clinics Ltd. RZ fundings Surgeons England. All authors have nothing declare. Ethics Approval Statement: protocol amendments (See Protocol) approved London-Dulwich Committee (17/LO/0950). Centre University London.