An updated study protocol for a real-life digital 12-month weight management program, the Healthy Weight Coaching.

Obesity is an important health concern that poses many public health challenges. Evidence-based treatment modalities, capable of cost-effectively reaching large patient groups are needed. In this paper, we present the design and methods of the updated national, 12-month, digital weight management program, the Healthy Weight Coaching (HWC). The major updates, as compared to the previous version, are related to the theoretical background of the obesity management and updated BMI cut-offs. The HWC is available, based on physicians' referrals, to adult Finnish citizens with BMI ≥30 kg/m2 or ≥27 kg/m2 with a comorbidity, who have a health-based need to lose weight. Rooted in the principles of behavioural therapy, the HWC focuses on teaching coping skills, guides to healthy self-reflection, and supports concrete lifestyle changes as part of healthy weight loss. The automated weekly training sessions, supplemented by 3-8 exercises, form the basis of the program. These sessions address topics such as diet, physical activity, stress management, and rest and recovery. Additionally, a personal coach is allocated to each patient to provide tailored support. At baseline, patients record their weight, height, and waist circumference, online, and complete questionnaires on lifestyle, diet, physical activity, sleep, psychological factors, and health. Thereafter weight recording is conducted at least every 4 weeks, while the questionnaires and measuring the weight circumference are repeated at 3, 6, 9, and 12 months. In addition, patients can make use of diaries and peer group chats for additional support. Data collected from the consenting patients will be used for research purposes with the weight change from baseline to 12 months as the main outcome in the real-life observational study. The study will provide invaluable insights into the application of digital modalities in the treatment of obesity.

Searching for the Scale-Able Weight Loss Intervention: Can One Size Fit All? Lessons to Be Learned from the EQUAL Trial.

Overweight and obesity affect 71.2% of adults in the United States, with cancer survivors not far behind at 70.3%. Subgroups such as those diagnosed with acute lymphoblastic leukemia (ALL) face even greater challenges. The Exercise and Quality Diet after Leukemia (EQUAL) trial sought to address weight management issues among ALL survivors by implementing a remotely delivered weight loss intervention, leveraging the previously proven Practice-based Opportunities for Weight Reduction (POWER) program. Despite a strong foundation and design, the EQUAL trial yielded null results. Key differences in study populations and intervention contexts between the EQUAL and POWER trials, such as the lack of primary care physician involvement in EQUAL, contributed to these outcomes. EQUAL's failure to meet its accrual target and poor adherence among participants highlighted challenges in engaging this unique population. Contrary to EQUAL's conclusions, evidence from other studies supports the efficacy of remote interventions for weight loss among cancer survivors. The lack of qualitative assessment among ALL survivors and key integration to inform intervention adaptations undermined EQUAL's impact. However, EQUAL's impressive retention rate offers valuable insights. Lessons from EQUAL underscore the need for well-fitted, remotely delivered interventions and the importance of thoughtfully adapted and tailored approaches to specific survivor populations. See related article by Fiedmann et al., p. 1158.

The psychosocial beliefs, experiences and expectations of children living with obesity.

BACKGROUND: Childhood obesity has been shown to impair psychological health. However, psychological factors are often overlooked in both research evaluations and treatment interventions, and children's perspectives on managing obesity are underexplored. Neglecting psychosocial factors might undermine interventions. This research explored the psychological beliefs, expectations and experiences of children living with obesity (range 7-13) and attending a weight management programme (WMP). METHODS: Thirty-four participants (19 females, 15 males, average age 9.5 years) completed a semistructured interview. Recorded interviews were transcribed verbatim and analysed using thematic analysis. RESULTS: Four overarching themes were developed: (1) defining health and self-recognition; (2) external influence; feedback, stigma and comparison; (3) recognising emotions and (4) future expectations: obesity is a reality. These themes interact to influence the children's psychosocial status. CONCLUSIONS: This study highlights a range of psychosocial and emotional difficulties that children living with obesity experience and suggests that these remain regardless of their attendance at a WMP. Interventions for children living with obesity should address psychosocial factors, including stress management, peer victimisation and handling feedback from others. PATIENT OR PUBLIC CONTRIBUTION: As proposed by the two young people acting as patient and public involvement and engagement representatives, the utilisation of scrapbooks as a preinterview tool was particularly helpful in aiding discussion during the interviews. This innovative approach could be considered a valuable methodological technique for investigating sensitive topics with children in future research.

The lived experience of weight loss maintenance in young people.

INTRODUCTION: There continues to be an imbalance of research into weight loss and weight loss maintenance (WLM), with a particular lack of research into WLM in young people under 18 years. Failure to coherently understand WLM in young people may be a potential contributor to the underdeveloped guidance surrounding long-term support. Furthermore, no research has investigated young people's preferences around WLM support following the attendance of a residential intensive weight loss intervention from a qualitative perspective. This study explored the influences of WLM in young people following a residential intensive weight loss intervention, considered how interventions could be improved and sought to develop recommendations for stakeholders responsible for designing WLM interventions. METHODS: The context in which this research is framed was taken from a residential Intensive Weight Loss Intervention for young people aged 8-17 years in England. Six semi-structured interviews were carried out to understand the lived experience of WLM, including barriers and enablers influencing WLM, adopting an interpretative phenomenological analysis design. FINDINGS: Three superordinate themes were developed to explain the barriers and enablers to WLM; (1) Behavioural control and the psychosocial skills to self-regulate WLM; (2) Delivering effective social support; and (3) Conflicting priorities and environmental triggers. CONCLUSION: The findings of this research mirror that of other studies of WLM in young people, with the majority of young people struggling to maintain weight loss. However, by exploring the experience of WLM in young people through qualitative means, it was possible to understand the specific motivators and barriers influencing WLM behaviours in this context, providing recommendations to support WLM. PATIENT OR PUBLIC CONTRIBUTION: The interview guide was developed in consultation with a young person from the intervention, and through discussions with the intervention stakeholders (delivery staff and management staff). The interview guide included topics such as knowledge and skills; experience of weight loss; reflections on weight maintenance, and experiences of daily life postintervention. We piloted the interview schedule with one young person who had consented to take part in the research. This first interview was used to check for understanding of questions and to assess the flow of the interview.

Developing an 8-Week, Tele-Education Weight Control and Exercise Programme, and Evaluating Its Effects on Weight and Pain Reduction in Patients With Obesity and Knee Osteoarthritis: A Double-Blinded Randomised Clinical Trial.

BACKGROUND: Knee osteoarthritis (OA) is a leading cause of disability among the elderly and is often exacerbated by obesity. Research supports weight loss and exercise therapy as key strategies for managing knee OA-related disability. Concurrently, telemedicine is becoming a popular healthcare approach. This study aimed to develop and evaluate an 8-week tele-education programme's impact on weight control and knee OA outcomes. METHODS/DESIGN: Participants with knee OA and obesity were included. Baseline data on pain (VAS index), physical activity (GPAQ questionnaire), and quality of life (EQ5D and KOOS questionnaires) were collected. Performance tests, including the 30-second Chair Stand test (30CST) and the Timed Up-and-Go test (TUG), were recorded. Participants were randomly divided into two groups: a control group receiving oral advice on diet and exercise, and an intervention group receiving educational videos on nutrition, lifestyle changes, physical activity, individualised exercises, and psychosocial support. Evaluations were repeated after 8 weeks. RESULTS: Data from 25 of 30 participants were analysed. In the intervention group, body composition, waist, and abdominal circumference decreased significantly (p < 0.05). The KOOS questionnaire showed significant improvements in pain, activity, and daily tasks (p = 0.00). The EQ5D questionnaire and health satisfaction also showed positive results within the intervention group (p = 0.00) and between groups (p = 0.008). The pain index improved significantly within (p = 0.00) and between groups (p = 0.02). Functional test results were significant within the intervention group (p = 0.00) and between groups (p = 0.017 for 30CST and p = 0.004 for TUG). CONCLUSION: An 8-week tele-education programme for weight control and exercise therapy in knee OA patients significantly improved body composition, quality of life, and functional performance. Given the costs of obesity and knee OA on both people and the health system, tele-education can be a cost-effective treatment strategy.

Effect of weight loss interventions on metabolomic signatures in obese children with insulin resistance.

The obesity epidemic among children has become a major public health issue, and the presence of childhood insulin resistance (IR) has been demonstrated prior to the onset of type 2 diabetes mellitus. However, it is unclear whether the metabolomic signature is associated with weight loss interventions in obese children with IR. Thirty-six obese children with IR were selected from the weight loss camp (Shenzhen Sunshine Xing Yada health Technology Co., LTD). Clinical parameters were collected before and after weight loss intervention. Targeted metabolomics of plasma samples was performed by ultra-performance liquid chromatography coupled to the tandem mass spectrometry, and principal component analysis, variable importance in projection, and orthogonal partial least squares discriminant analysis were used to obtain the differentially expressed metabolites. Pathway analysis was conducted with the Homo sapiens (HSA) sets in the Kyoto Encyclopedia of Genes and Genomes. We used machine learning algorithms to obtain the potential biomarkers and Spearman correlation analysis to clarify the association between potential biomarkers and clinical parameters. We found that clinical parameters and metabolite clusters were significantly changed in obese children with IR before and after weight loss intervention. Mechanistically, weight loss intervention significantly changed 61 metabolites in obese children with IR. Furthermore, 12 pathways were significantly changed. Moreover, the machine learning algorithm found 6 important potential biomarkers. In addition, these potential biomarkers were strongly associated with major clinical parameters. These data indicate different metabolomic profiles in obese children with IR after weight loss intervention, providing insights into the clinical parameters and metabolite mechanisms involved in weight loss programs.

Effects of Probiotic Supplementation Added to a Weight Loss Program on Anthropometric Measures, Body Composition, Eating Behavior, and Related Hormone Levels in Patients with Food Addiction and Weight Regain After Bariatric Surgery: A Randomized Clinical Trial.

PURPOSE: Weight regain after metabolic bariatric surgery is a common problem. Food addiction is an eating disorder that can be one of the reasons for weight regain in these patients. This study aimed to evaluate the effects of probiotic supplementation with a weight loss program and cognitive behavioral therapy (CBT) on anthropometric measures, eating behavior, food addiction, and related hormone levels, in patients with food addiction and weight regain after metabolic bariatric surgery. MATERIALS AND METHODS: This randomized, triple-blind, placebo-controlled clinical trial was conducted on patients with food addiction and weight regain after metabolic bariatric surgery. Participants (n = 50) received a weight loss program and CBT plus probiotic, or placebo for 12 weeks. Then, anthropometric measurements, biochemical markers, eating behavior, and food addiction were assessed. RESULTS: Weight and body mass index (BMI) decreased significantly in the probiotic group compared to placebo (p = 0.008, p = 0.001, respectively). Fat mass was significantly decreased in the probiotic group (p < 0.001). Moreover, a significant improvement was observed in the probiotic group's eating behavior and food addiction compared to the placebo group (p < 0.001). Serum levels of leptin decreased significantly (p = 0.02), and oxytocin serum levels increased significantly (p = 0.008) in the probiotic group compared to the placebo group. CONCLUSION: Adding probiotic supplements to the weight loss program and CBT is superior to the weight loss program and CBT alone in improving weight loss, eating behavior, and food addiction in patients with food addiction and weight regain after metabolic bariatric surgery.

Improving Equity of Access to a Publicly Funded Bariatric Surgery Programme by Removal of Mandatory Weight Loss Targets.

INTRODUCTION: Obesity disproportionately affects 50.8% of Maori and 71.3% of Pacific adults in New Zealand, and these groups also have reduced access to bariatric surgery. Mandatory preoperative weight loss targets are a requirement of many bariatric surgery programmes globally; however, the evidence supporting their efficacy is inconclusive. In 2017, mandatory preoperative weight loss targets were eliminated from the bariatric surgery programme at Auckland City Hospital in New Zealand, with the aim to improve equity of access to bariatric surgery. This study will review postoperative patient outcomes following the elimination of preoperative weight loss targets from the programme. METHODS: A retrospective analysis of 231 patients who underwent bariatric surgery at Auckland City Hospital from 2018 to 2021 was performed. Nineteen patients were lost to follow up and 12 were excluded (revision surgery or pregnancy). The comparison group of 100 consecutive patients, retrospective from 2017, had been required to lose 10% of excess body weight preoperatively to qualify for surgery. Outcomes assessed were weight loss and diabetes resolution at 12 months, and postoperative complications within 90 days. RESULTS: Elimination of preoperative weight loss targets was associated with greater numbers of Maori and Pacific patients undergoing bariatric surgery. There was no significant difference in weight loss outcomes or postoperative complications. CONCLUSION: Elimination of preoperative weight loss targets improves access to bariatric surgery for Maori and Pacific patients, inequitably affected by obesity. Removal of preoperative weight loss targets does not adversely affect weight loss outcomes, or postoperative complications, thus supporting their elimination.

A Mobile-Based Nutrition Tracker App Enhanced Dietitian-Guided 2:1:1 Diet-Induced Weight Loss: An 8-Week Retrospective Cohort Study in Taiwan.

Effective weight management interventions involve a combination of behavioral strategies focusing on dietary changes. Tracing the change through mobile apps has been proven to be a valuable platform for facilitating weight management in many countries. However, the effectiveness of mobile app-based dietary intervention on weight management in Taiwan remains to be determined. By using the designated mobile app, this study aimed to assess the efficacy of the diet intervention, which is based on a 2:1:1 portion control plate and a flexible low-carbohydrate (FLC) diet. This 8-week retrospective cohort study involved 10,297 participants who were divided into two groups: the intervention group (joined an 8-week diet intervention program with the daily diet record assessed by registered dietitians) and the control group (voluntarily using the app without instructional materials or coaching). After eight weeks of intervention, the intervention group showed a higher weight loss percentage (-4.78% vs. -1.54%), body mass index (BMI) (-1.26 kg/m2 vs. 0.69 kg/m2), and diet record completeness (73.52% vs. 28.91%) compared with the control group. With respect to gender, male participants showed higher baseline weight and higher weight loss (-6.02%) in the intervention group. In the intervention group, 2871 participants (33.4%) lost less than 4% of their weight, 5071 participants (58.9%) lost 4-8% of their body weight, and 662 participants (7.7%) lost >8% of their weight. Compared to the low-effectiveness group (weight lost <4%), the high-effectiveness group (weight lost >8%) had a significantly higher diet record completeness (91.61 ± 15.99 vs. 55.81 ± 32.92), dietary compliance (green light %) (88.93 ± 9.9 vs. 77.75 ±17.5), protein intake % (26.34 ± 2.85 vs. 23.49 ± 3.56), and fat intake % (49.66 ± 6.36 vs. 44.05 ± 7.37). Most importantly, the high-effectiveness group had a lower carbohydrate intake % (24.1 ± 7.86 vs. 32.46 ± 9.61). The results remained significant after being stratified by gender. This study found that the use of online applications plus the intervention of dietitians is beneficial for short-term weight loss. The composition of nutrients and dietary compliance also significantly impacted weight loss.

Understanding experiences and perspectives in addressing unmet social needs of children and families in a paediatric weight management program: a qualitative descriptive study.

OBJECTIVE: The objective is to describe the experiences and perceptions of caregivers who participated in a community systems navigator intervention that addressed unmet social needs. DESIGN, SETTING AND PATIENTS: A qualitative descriptive study with caregivers of children enrolled in a clinical trial addressing unmet social needs of families with children cared for in a tertiary pediatric weight management clinic, through community systems navigation. Participants were asked open-ended questions related to perceptions of social needs screening in clinical settings. Interviews were recorded and analysed using Braun and Clarke's six-phase approach to thematic analysis. RESULTS: Ten parent participants were interviewed. Social needs screening perception and acceptability varied between participants. Social needs screening was comfortable for most but stressful for others. Participants noted that trusting relationships promote comfort with sharing social needs information, and this data should be shared on the electronic health record if accurate and purposeful. They found the online screening tool convenient but thought it could also limit opportunities to elaborate. Some participants noted the intervention of community systems navigation helpful; however, others described the need for more tailored resources. CONCLUSIONS: Screening for unmet social needs in clinical settings is complex and should be family centred, including the consideration of the mode of screening, data sharing in the electronic health record and ensuing interventions. Perspectives of families should drive the design of future larger scale community navigation interventions to address unmet social needs in clinical settings.

An intense 60-day weight-loss course leads to an 18 kg body weight reduction and metabolic reprogramming of soldiers with obesity.

Soldiers of the Mexican Army with obesity were subjected to an intense 60-day weight-loss course consisting of a controlled diet, daily physical training, and psychological sessions. The nutritional treatment followed the European Society of Cardiology (ESC) recommendations, incorporating elements of the traditional milpa diet in the nutritional intervention. The total energy intake was reduced by 200 kcal every 20 days, starting with 1,800 kcal and ending with 1,400 kcal daily. On average, the participants reduced their body weight by 18 kg. We employed an innovative approach to monitor the progress of the twelve soldiers who completed the entire program. We compared the untargeted metabolomics profiles of their urine samples, taken before and after the course. The data obtained through liquid chromatography and high-resolution mass spectrometry (LC-MS) provided insightful results. Classification models perfectly separated the profiles pre and post-course, indicating a significant reprogramming of the participants' metabolism. The changes were observed in the C1-, vitamin, amino acid, and energy metabolism pathways, primarily affecting the liver, biliary system, and mitochondria. This study not only demonstrates the potential of rapid weight loss and metabolic pathway modification but also introduces a non-invasive method for monitoring the metabolic state of individuals through urine mass spectrometry data.

Long-term cost-effectiveness analysis of rugby fans in training-New Zealand: a body weight reduction programme for males.

OBJECTIVES: We sought to extrapolate the long-term costs and clinical impacts attributed to the rugby fans in training-New Zealand (RUFIT-NZ) trial in Aotearoa, New Zealand. DESIGN: A modelled cost-effectiveness analysis using efficacy data from RUFIT-NZ was conducted from the Aotearoa New Zealand healthcare perspective. SETTING: A Markov cohort model was constructed with a lifetime time horizon. The model simulated events of myocardial infarction (MI), stroke and type 2 diabetes mellitus (T2DM) occurring among a hypothetical cohort of 10 000 individuals receiving either the RUFIT-NZ intervention or no intervention. Efficacy data were based on the RUFIT-NZ trial, and the latest Global Burden of Disease study was used to extrapolate the impact of body weight reduction on clinical outcomes of T2DM, MI or stroke. Cost and utility data were drawn from the RUFIT-NZ trial and published sources. PRIMARY OUTCOME MEASURES: The incremental cost-effectiveness ratio (ICER). RESULTS: Over a lifetime time horizon, participants in the RUFIT-NZ intervention gained 0.02 (discounted) quality-adjusted life years (QALYs) at an additional cost of NZ$863, relative to no intervention. The estimated ICER was NZ$49 515 per QALY gained (discounted), which is above the arbitrary willingness-to-pay threshold of NZ$45 000 per QALY. Sensitivity analyses supported the robustness of these findings. CONCLUSIONS: RUFIT-NZ was associated with a reduction in cardiovascular and endocrine events for overweight and obese males. However, based on conservative assumptions, RUFIT-NZ was unlikely to be cost-effective from a healthcare system perspective. TRIAL REGISTRATION NUMBER: ACTRN12619000069156.

Cardio-metabolic health effects of CPAP treatment for sleep apnoea during weight loss: A randomised controlled pilot trial.

BACKGROUND AND AIMS: This study assessed whether the addition of continuous positive airway pressure (CPAP) during weight loss would enhance cardiometabolic health improvements in patients with obesity and Obstructive Sleep Apnoea (OSA). METHODS AND RESULTS: Patients with overweight or obesity, pre-diabetes and moderatesevere OSA were randomised to receive CPAP therapy with a weight loss programme (CPAP+WL) or a weight loss programme alone (WL alone). PRIMARY OUTCOME: 2-hour glucose assessed by an oral glucose tolerance test. SECONDARY OUTCOMES: 24 hr blood pressure, body composition (DEXA) and fasting blood markers. 17 patients completed 3-month follow-up assessments (8 CPAP+WL and 9 WL alone). Overall, participants in both groups lost ∼12 kg which reduced polysomnography determined OSA severity by ∼45 %. In the CPAP+WL group, CPAP use (compliance 5.29 hrs/night) did not improve any outcome above WL alone. There was no improvement in 2-hour glucose in either group. However, in the pooled (n = 17) analysis there were overall improvements in most outcomes including insulin sensitivity (.000965 units, p = .008), sleep systolic BP (- 16.2 mmHg, p = .0003), sleep diastolic BP (-9.8 mmHg, p = 0.02), wake diastolic BP (- 4.3 mmHg, p = .03) and sleepiness (Epworth Sleepiness Score -3.2, p = .0003). In addition, there were reductions in glucose area under the curve (-230 units, p = .009), total (-0.86 mmol/L, p = 0.006) and LDL cholesterol (-0.58 mmol/L, p = 0.007), triglycerides (-0.75 mmol/L, p = 0.004), fat mass (-7.6 kg, p < .0001) and abdominal fat (-310 cm3, p < .0001). CONCLUSION: Weight loss reduced OSA and improved sleepiness and cardiometabolic health. These improvements were not further enhanced by using CPAP. Results suggest weight loss should be the primary focus of treatment for patients with OSA and obesity.

Effects of weight loss rate on myostatin and follistatin dynamics in patients with obesity.

Background: Exercise-induced cytokines involved in controlling body composition include myostatin (MST) and follistatin (FST), both of which are influenced by physical activity. This study investigated changes in body composition and physical activity during a weight loss program, as well as the impact on serum MST and FST levels at various weight loss rates. Methods: A total of 126 patients with obesity who completed a 6-month weight loss program were divided into three groups based on weight loss rate (%): low (< 3%), middle (3-10%), and high (≥10%). The International Physical Activity Questionnaire was used for assessing physical activity, whereas dual X-ray absorptiometry was used to determine body composition. Serum MST and FST levels were measured using the enzyme-linked immunosorbent assay. Results: The middle and high groups showed a significant decrease in percent body fat and a significant increase in percent lean body mass and physical activity. Serum MST levels increased significantly in all three groups, although FST levels reduced significantly only in the middle group. After adjusting for sex and body composition, changes in peak oxygen intake (ß = -0.359) and serum FST levels (ß = -0.461) were identified as independent factors for the change in MST levels in the low group. Sex (ß = -0.420) and changes in MST levels (ß = -0.525) were identified as independent factors for the change in serum FST levels in the low group, whereas in the high group, sitting time (ß = -0.600) during the weight loss program was identified as an independent factor for change in serum FST levels. Conclusion: Serum MST levels in patients with obesity increased significantly following the weight loss program, independent of weight loss rate. In contrast, serum FST levels reduced significantly only in the 3-10% weight loss group. These findings indicate that MST and FST secretion dynamics may fluctuate in response to physical activity, while also reflecting feedback regulation of body composition and metabolism during weight reduction.

Exploring Determinants of Successful Weight Loss with the Use of a Smartphone Healthcare Application: Secondary Analysis of a Randomized Clinical Trial.

Dietary and physical activity interventions through smartphone healthcare applications (apps) have recently surged in popularity as effective methods for weight loss. However, the specific factors contributing to successful weight loss remain uncertain. We conducted an analysis of baseline characteristics and app usage frequencies over three months among 68 Japanese adults with overweight and obesity who were assigned to the intervention group in a previous randomized controlled trial. Logistic regression analysis revealed a negative association (OR: 0.248; p = 0.018) between having a walking habit at baseline and successful weight loss, defined as a 3% reduction in initial weight. Additionally, slower walking speeds and family medical history were identified as potential predictors of successful weight loss. These findings offer insights into the profile of individuals who achieve success in weight loss through our smartphone app, providing valuable guidance for the development of future healthcare apps.

Outcomes from Partner2Lose: a randomized controlled trial to evaluate 24-month weight loss in a partner-assisted intervention.

BACKGROUND: Partner support is associated with better weight loss outcomes in observational studies, but randomized trials show mixed results for including partners. Unclear is whether teaching communication skills to couples will improve weight loss in a person attempting weight loss (index participant). PURPOSE: To compare the efficacy of a partner-assisted intervention versus participant-only weight management program on 24-month weight loss. METHODS: This community-based study took place in Madison, WI. Index participants were eligible if they met obesity guideline criteria to receive weight loss counseling, were aged 18-74 years, lived with a partner, and had no medical contraindications to weight loss; partners were aged 18-74 years and not underweight. Couples were randomized 1:1 to a partner-assisted or participant-only intervention. Index participants in both arms received an evidence-based weight management program. In the partner-assisted arm, partners attended half of the intervention sessions, and couples were trained in communication skills. The primary outcome was index participant weight at 24 months, assessed by masked personnel; secondary outcomes were 24-month self-reported caloric intake and average daily steps assessed by an activity tracker. General linear mixed models were used to compare group differences in these outcomes following intent-to-treat principles. RESULTS: Among couples assigned to partner-assisted (n = 115) or participant-only intervention (n = 116), most index participants identified as female (67%) and non-Hispanic White (87%). Average baseline age was 47.27 years (SD 11.51 years) and weight was 106.55 kg (SD 19.41 kg). The estimated mean 24-month weight loss was similar in the partner-assisted (2.66 kg) and participant-only arms (2.89 kg) (estimated mean difference, 0.23 kg [95% CI, -1.58, 2.04 kg], p=0.80). There were no differences in 24-month average daily caloric intake (estimated mean difference 50 cal [95% CI: -233, 132 cal], p=0.59) or steps (estimated mean difference 806 steps [95% CI: -1675, 64 steps], p=0.07). The percentage of participants reporting an adverse event with at least possible attribution to the intervention did not differ by arm (partner-assisted: 9%, participant-only, 3%, p = 0.11). CONCLUSIONS: Partner-assisted and individual weight management interventions led to similar outcomes in index participants. TRIAL REGISTRATION: Clinicaltrials.gov NCT03801174, January 11, 2019.

Participants' perspectives of being recruited into a randomised trial of a weight loss intervention before colorectal cancer surgery: a qualitative interview study.

BACKGROUND: The period between cancer diagnosis and surgery presents an opportunity for trials to assess the feasibility of behaviour change interventions. However, this can be a worrying time for patients and may hinder recruitment. We describe the perspectives of patients with excess weight awaiting colorectal cancer surgery about their recruitment into a randomised trial of a prehabilitation weight loss intervention. METHODS: We interviewed the first 26 participants from the 8 recruitment sites across England in the 'CARE' feasibility trial. Participants were randomised into either usual care (n = 13) or a low-energy nutritionally-replete total diet replacement programme with weekly remote behavioural support by a dietitian (n = 13). The semi-structured interviews occurred shortly after recruitment and the questions focused on participants' recollections of being recruited into the trial. We analysed data rapidly and then used a mind-mapping technique to develop descriptive themes. Themes were agreed by all co-authors, including a person with lived-experience of colorectal surgery. RESULTS: Participants had a mean body mass index (± SD) of 38 kg/m2 (± 6), age of 50 years (± 12), and 42% were female. People who participated in the trial were motivated by the offer of structured weight loss support that could potentially help them improve their surgical outcomes. However, participants also had concerns around the potential unpalatability of the intervention diet and side effects. Positive attitudes of clinicians towards the trial facilitated recruitment but participants were disappointed when they were randomised to usual care due to clinical teams' overemphasis on the benefits of losing weight. CONCLUSIONS: Patients were motivated to take part by the prospect of improved surgical outcomes. However, the strong preference to be allocated to the intervention suggests that balanced communication of equipoise is crucial to minimise disappointment from randomisation to usual care and differential dropout from the trial. CLINICAL TRIAL REGISTRATION: ISRCTN39207707, Registration date 13/03/2023.

Optimising a digitally delivered behavioural weight loss programme: study protocol for a factorial cluster randomised controlled trial.

BACKGROUND: Digitally 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. METHODS: Approximately 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. DISCUSSION: The 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 REGISTRATION: Trial registration: ISRCTN, ISRCTN14407868. Registered 5 January 2024, 10.1186/ISRCTN14407868.

Long-term trajectories of weight loss and health outcomes: protocol of the SCOOP-RNPC nationwide observational study.

INTRODUCTION: Behavioural weight loss programmes are generally accepted as being beneficial in reducing cardiometabolic risk and improving patient-reported outcomes. However, prospective data from large real-world cohorts are scarce concerning the mid-term and long-term impact of such interventions. The objective of this large prospective cohort study (n>10 000 participants) is to demonstrate the effectiveness of the standardised Nutritional and Psycho-Behavioural Rehabilitation programme (RNPC Programme) in reducing the percentage of subjects requiring insulin and/or other diabetes drug therapy, antihypertensive drugs, lipid-lowering therapies and continuous positive airway pressure therapy for obstructive sleep apnoea after the end of the intervention. The rate of remission of hypertension, type 2 diabetes and sleep apnoea will also be prospectively assessed. METHODS: This is a prospective multicentre observational study carried out in 92 RNPC centres in France. Participants will follow the standardised RNPC Programme. The prospective dataset will include clinical, anthropometric and biochemical data, comorbidities, medications, body composition, patient-reported outcome questionnaire responses, sleep study data with objective measurements of sleep apnoea severity and surrogate markers of cardiovascular risk (ie, blood pressure and arterial stiffness). About 10 000 overweight or obese participants will be included over 2 years with a follow-up duration of up to 5 years. ETHICS AND DISSEMINATION: Ethical approval for this study has been granted by the Ethics Committee (Comité de protection des personnes Sud-Est I) of Saint-Etienne University Hospital, France (SI number: 23.00174.000237). Results will be submitted for publication in peer-review journals, presented at conferences and inform the design of a future randomised controlled trial in the specific population identified as good responders to the RNPC Programme. TRIAL REGISTRATION NUMBER: NCT05857319.

Gender-sensitive community weight-loss programmes to address overweight and obesity in men: a scoping review.

OBJECTIVES: To examine how gender-sensitive community weight-loss programmes have been used to address overweight and obesity in men and to identify what can be learnt from this rapidly evolving field. DESIGN: Scoping review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping review checklist for reporting. DATA SOURCES: A database search was conducted using EBSCOhost (Academic Search Complete, CINAHL Complete, Global Health, Health Source: Consumer Edition, Health Source: Nursing/Academic Edition and Medline Complete), Google, Google Scholar, Open Access Theses and Dissertations platform and Scopus. ELIGIBILITY CRITERIA: All weight-loss programmes using a gender-sensitive approach to address men's overweight and obesity in community settings. DATA EXTRACTION AND SYNTHESIS: Narrative synthesis was conducted based on the research questions and objectives. Primary outcomes include operationalisation, context and concept of the gender-sensitive approach. Information was reviewed and extracted to Microsoft Excel by two reviewers. RESULTS: A total of 40 studies (28 quantitative, eight mixed methods and four qualitative) were identified from 4617 records. Gender-sensitive approaches were undertaken in a range of settings and contexts including professional sports clubs (n=21), non-professional sporting clubs (n=16), workplace-based (n=2) and commercial organisation-based (n=1). The most common analysis approaches were evaluating the effect of the programmes (n=31) where positive impact was predominantly shown (eg, up to 3.9 kg weight reduction at 3-month follow-up). Programmes (ie, Football Fans in Training) were short-term cost-effective (eg, the cost was £862-£2228 per 5% weight reduction at 12-month follow-up). Qualitative evidence highlights factors that influenced men's participation (eg, camaraderie) and identifies areas for improvement. CONCLUSION: The findings demonstrate that gender-sensitive programmes for men's weight loss have been effectively applied using a range of different approaches and in a range of different contexts. Further evidence is needed to confirm the effectiveness of the programmes across diverse groups of men.