Dataset Information

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

ABSTRACT:

Introduction

Behavioural weight loss (BWL) treatment is the standard evidence-based treatment for severe obesity (SO; body mass index ≥40.0 kg/m² or ≥35.0 kg/m² with 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 analysis

In 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 dissemination

The 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.

Registration

This study was registered at the German Clinical Trials Register (DRKS00026018), www.drks.de.

Trial registration number

DRKS00026018.

SUBMITTER: Hilbert A

PROVIDER: S-EPMC9980333 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Publications

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

Hilbert Anja A Juarascio Adrienne A Prettin Christiane C Petroff David D Schlögl Haiko H Hübner Claudia C

BMJ open 20230228 2

<h4>Introduction</h4>Behavioural weight loss (BWL) treatment is the standard evidence-based treatment for severe obesity (SO; body mass index ≥40.0 kg/m<sup>2</sup> or ≥35.0 kg/m<sup>2</sup> with 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 ai ...[more]

PMID: 36854588

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Project description:BackgroundApproximately 15 million people in the UK live with obesity, around 5 million of whom have severe obesity (body mass index (BMI) ≥35kg/m2). Having severe obesity markedly compromises health, well-being and quality of life, and substantially reduces life expectancy. These adverse outcomes are prevented or ameliorated by weight loss, for which sustained behavioural change is the cornerstone of treatment. Although NHS specialist 'Tier 3' Weight Management Services (T3WMS) support people with severe obesity, using individual and group-based treatment, the current evidence on optimal intervention design and outcomes is limited. Due to heterogeneity of severe obesity, there is a need to tailor treatment to address individual needs. Despite this heterogeneity, there are good reasons to suspect that a structured group-based behavioural intervention may be more effective and cost-effective for the treatment of severe obesity compared to usual care. The aims of this study are to test the feasibility of establishing and delivering a multi-centre randomised controlled clinical trial to compare a group-based behavioural intervention versus usual care in people with severe obesity.MethodsThis feasibility randomised controlled study is a partially clustered multi-centre trial of PROGROUP (a novel group-based behavioural intervention) versus usual care. Adults ≥18 years of age who have been newly referred to and accepted by NHS T3WMS will be eligible if they have a BMI ≥40, or ≥35 kg/m2 with comorbidity, are suitable for group-based care and are willing to be randomised. Exclusion criteria are participation in another weight management study, planned bariatric surgery during the trial, and unwillingness or inability to attend group sessions. Outcome assessors will be blinded to treatment allocation and success of blinding will be evaluated. Clinical measures will be collected at baseline, 6 and 12 months post-randomisation. Secondary outcome measures will be self-reported and collected remotely. Process and economic evaluations will be conducted.DiscussionThis randomised feasibility study has been designed to test all the required research procedures and additionally explore three key issues; the feasibility of implementing a complex trial at participating NHS T3WMS, training the multidisciplinary healthcare teams in a standard intervention, and the acceptability of a group intervention for these particularly complex patients.Trial registrationISRCTN number 22088800.

Project description:IntroductionIndividuals with obesity show deficits in executive functioning which have been implicated in decreased weight loss outcome. Preliminary evidence suggests that cognitive remediation therapy (CRT) improves executive functioning and weight loss in obesity. However, confirmatory support, especially for pre-weight loss use, is lacking. The CRT study aims at determining the efficacy of CRT versus no treatment control in patients with obesity before entering behavioural weight loss (BWL) treatment. It is hypothesised that individuals who receive CRT will show better weight loss outcome, improved executive functioning, greater weight loss-related behavioural changes and higher attendance of BWL treatment, 6 and 12 months after cessation of CRT.Methods and analysisIn a single-centre, assessor-blinded, randomised, two-armed parallel-group superiority trial, 260 adults with body mass index ≥35.0 kg/m2 are centrally randomised to 8-week group-based CRT versus no treatment, before entering BWL treatment. Primary outcome is the amount of weight loss (%) at 6-month follow-up, compared with pre-treatment, derived from measured body weight. Secondary outcomes include improvement in executive functioning post-treatment and in weight loss-related behaviour, mental and physical health, and attendance to BWL treatment at 6-month and 12-month follow-up. Maintenance of weight loss at 12-month follow-up will be determined. Mixed model analyses based on intent-to-treat will be used to compare the CRT and control groups with respect to differences in weight change between pre-treatment and 6-month follow-up. Similar models will be used for analysing 12-month follow-up data and secondary outcomes. Further analyses will include additional covariates to identify predictors of treatment outcome.Ethics and disseminationThe study was approved by the Ethical Committee of the University of Leipzig (256-15-13072015, version 'Final 1.0 from 28 May 2015). The study results will be disseminated through peer-reviewed publications.Trial registration numberDRKS00009333; Pre-results.

Project description:BackgroundDigitally delivered weight loss programmes can provide a convenient, potentially cheaper, and scalable treatment option for people who may need to lose weight. However, outcomes are often inferior to in-person interventions in the long-term. This trial will use principles from the Multiphase Optimisation Strategy (MOST) framework to test whether it can enhance the effectiveness of a commercial digital behavioural weight loss programme. This trial aims to identify an optimised combination of four intervention components to enhance weight loss over a 24-week period. We will also explore which components contribute to improvements in participant retention and engagement with the programme.MethodsApproximately 1400 adults with a BMI > 21 kg/m2 will be enrolled and randomised to one of 16 experimental conditions in a 24 factorial cluster design. The trial will test four intervention components: an introductory video call with the health coach, drop-in webchat sessions with the health coach, goal setting statements, and food diary review and feedback. All participants will receive the core digital behavioural weight loss programme and up to four new intervention components. Participation in the trial will last for 24 weeks. The primary outcome will be weight change at 16 weeks. Other outcomes, measured at 4, 16, and 24 weeks, include programme drop-out and engagement (number of interactions with the three main app functions). Fidelity and acceptability will be assessed using data on component adherence and self-report questionnaires. Decision-making for the enhanced programme will be based on components that contribute to at least a minimal improvement in weight loss, defined as ≥ 0.75kg, alone or in combination with other components.DiscussionThe factorial design is an efficient way to test the efficacy of behavioural components alone, or in combination, to improve the effectiveness of digital weight loss programmes. This trial will test the implementation of the MOST framework in an industry setting, using routinely collected data, which may provide a better way to refine and evaluate these types of interventions in a model of continuous service improvement.Trial registrationTrial registration: ISRCTN, ISRCTN14407868. Registered 5 January 2024, 10.1186/ISRCTN14407868.

Project description:Background and study aims In the UK, 42,000 people each year are diagnosed with bowel cancer. It is the fourth most common cancer. Surgery to remove the cancer is the best treatment. However, it has a risk of complications, which is doubled for people who are overweight/obese. Patients experiencing complications recover more slowly, stay in the hospital longer and need more care. This isn’t good for patients or the NHS. Physical fitness and well-controlled blood sugar are linked with fewer complications from surgery. For people who are overweight, weight loss improves both of these factors so that it may reduce complications. One reliable way to lose a meaningful amount of weight in the short period before surgery (3-4 weeks) is through a low-calorie diet programme: eating only special nutritious soups and shakes (880 calories/day) that have all the necessary vitamins. With weekly support from a dietitian, most people succeed. Typically, people lose 5% of their weight within 20 days. The NHS uses a version of this programme to treat type 2 diabetes. In small-scale studies, patients with cancer who are overweight have been willing and able to take part in less intensive weight management programmes before surgery but lose little weight. However, the period before bowel cancer surgery is associated with feelings of uncertainty and anxiety, so it is unclear if patients can follow a more intensive programme. Who can participate? To start to find out if this treatment is in the best interests of patients’ physical and mental health, we will recruit 72 overweight patients awaiting bowel cancer surgery What does the study involve? Half of the participants will be randomly allocated to continue with their usual care and half will be offered the weight loss programme. We will see whether enough patients are willing to take part, lose weight, and return for follow-up visits. We will monitor complications for 30 days after surgery and any reduction in muscle mass due to the weight loss. We will interview patients about their experiences. This information will tell us if a full trial is worthwhile to test whether this programme can reduce complications from surgery, improve outcomes for people with bowel cancer, and if the financial costs are likely to be worth the benefits. It will also help us refine the treatment plans according to patient feedback. The researchers discussed the study with seven patients and public representatives (PPI). They thought it was a critical study and the team included their suggestions for making it easier for patients to join the trial, stick to the programme, and attend visits. The research team will work with the PPI throughout the trial.

Project description:BackgroundScalable weight loss maintenance (WLM) interventions for adults with obesity are lacking but vital for the health and economic benefits of weight loss to be fully realised. We examined the effectiveness and cost-effectiveness of a low-intensity technology-mediated behavioural intervention to support WLM in adults with obesity after clinically significant weight loss (≥5%) compared to standard lifestyle advice.Methods and findingsThe NULevel trial was an open-label randomised controlled superiority trial in 288 adults recruited April 2014 to May 2015 with weight loss of ≥5% within the previous 12 months, from a pre-weight loss BMI of ≥30 kg/m2. Participants were self-selected, and the majority self-certified previous weight loss. We used a web-based randomisation system to assign participants to either standard lifestyle advice via newsletter (control arm) or a technology-mediated low-intensity behavioural WLM programme (intervention arm). The intervention comprised a single face-to-face goal-setting meeting, self-monitoring, and remote feedback on weight, diet, and physical activity via links embedded in short message service (SMS). All participants were provided with wirelessly connected weighing scales, but only participants in the intervention arm were instructed to weigh themselves daily and told that they would receive feedback on their weight. After 12 months, we measured the primary outcome, weight (kilograms), as well as frequency of self-weighing, objective physical activity (via accelerometry), psychological variables, and cost-effectiveness. The study was powered to detect a between-group weight difference of ±2.5 kg at follow-up. Overall, 264 participants (92%) completed the trial. Mean weight gain from baseline to 12 months was 1.8 kg (95% CI 0.5-3.1) in the intervention group (n = 131) and 1.8 kg (95% CI 0.6-3.0) in the control group (n = 133). There was no evidence of an effect on weight at 12 months (difference in adjusted mean weight change from baseline: -0.07 [95% CI 1.7 to -1.9], p = 0.9). Intervention participants weighed themselves more frequently than control participants and were more physically active. Intervention participants reported greater satisfaction with weight outcomes, more planning for dietary and physical activity goals and for managing lapses, and greater confidence for healthy eating, weight loss, and WLM. Potential limitations, such as the use of connected weighing study in both trial arms, the absence of a measurement of energy intake, and the recruitment from one region of the United Kingdom, are discussed.ConclusionsThere was no difference in the WLM of participants who received the NULevel intervention compared to participants who received standard lifestyle advice via newsletter. The intervention affected some, but not all, process-related secondary outcomes of the trial.Trial registrationThis trial is registered with the ISRCTN registry (ISRCTN 14657176; registration date 20 March 2014).

Dataset Information

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

Introduction

Methods and analysis

Ethics and dissemination

Registration

Trial registration number

Publications

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

Similar Datasets

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