Smartphone-supported behavioural weight loss treatment in adults with severe obesity: study protocol for an exploratory randomised controlled trial (SmartBWL)

Abstract

IntroductionBehavioural weight loss (BWL) treatment is the standard evidence-based treatment for severe obesity (SO; body mass index ≥40.0 kg/m2or ≥35.0 kg/m2with obesity-related comorbidity), leading to moderate weight loss which often cannot be maintained in the long term. Because weight loss depends on patients’ use of weight management skills, it is important to support them in daily life. In an ecological momentary intervention design, this clinical trial aims to adapt, refine and evaluate a personalised cognitive-behavioural smartphone application (app) in BWL treatment to foster patients’ weight management skills use in everyday life. It is hypothesised that using the app is feasible and acceptable, improves weight loss and increases skills use and well-being.Methods and analysisIn the pilot phase, the app will be adapted, piloted and optimised for BWL treatment following a participatory patient-oriented approach. In the subsequent single-centre, assessor-blind, exploratory randomised controlled trial, 90 adults with SO will be randomised to BWL treatment over 6 months with versus without adjunctive app. Primary outcome is the amount of weight loss (kg) at post-treatment (6 months), compared with pretreatment, derived from measured body weight. Secondary outcomes encompass feasibility, acceptance, weight management skills use, well-being and anthropometrics assessed at pretreatment, midtreatment (3 months), post-treatment (6 months) and 6-month follow-up (12 months). An intent-to-treat linear model with randomisation arm, pretreatment weight and stratification variables as covariates will serve to compare arms regarding weight at post-treatment. Secondary analyses will include linear mixed models, generalised linear models and regression and mediation analyses. For safety analysis (serious) adverse events will be analysed descriptively.Ethics and disseminationThe study was approved by the Ethics Committee of the University of Leipzig (DE-21-00013674) and notified to the Federal Institute for Drugs and Medical Devices. Study results will be disseminated through peer-reviewed publications.RegistrationThis study was registered at the German Clinical Trials Register (DRKS00026018), www.drks.de.Trial registration numberDRKS00026018

Attitudes of psychiatrists toward telepsychiatry: A policy Delphi study

“…An increasing significance to the assimilation of telepsychiatry into health systems is driven by the emergence of multiple mobile applications that provide additional data concerning patients’ health and generating tighter communication between the different caretakers, and even informal caregivers . 42 Thus, apps that are unique to telepsychiatry could facilitate multiple advancements such as joint meetings of a group of caretakers exchanging ideas and data, 43 , 44 streaming of data collected from mobile-based apps that provide data concerning voice modulation, movement, money spending, social interactions, frequency of phone calls, and other data, 45 – 48 and also enable psychotherapeutic groups sessions 49 , 50 omitting the logistical requirements within a clinical facility.…”

Effect of intraoperative mild hyperventilation on the incidence of shoulder pain after laparoscopic sleeve gastrectomy: A randomized, controlled trial

“…Morbid obesity (BMI > 40 kg/m 2 or BMI > 35 kg/m 2 combined with other obesity-related diseases) can lead to hypertension, hyperlipidemia, diabetes, heart disease, etc., which can seriously affect people's physical health and cause a huge social burden. [14] As a widely used bariatric surgery, LSG was discussed in this study. Studies have shown that LSG has high…”

“…Morbid obesity (BMI > 40 kg/m 2 or BMI > 35 kg/m 2 combined with other obesity-related diseases) can lead to hypertension, hyperlipidemia, diabetes, heart disease, etc., which can seriously affect people’s physical health and cause a huge social burden. [14] As a widely used bariatric surgery, LSG was discussed in this study. Studies have shown that LSG has high safety, lasting postoperative weight loss, and can effectively alleviate the related comorbidities in morbidly obese patients, thus significantly improving the quality of life of morbidly obese patients.…”