The (cost) effectiveness of a very low-energy diet intervention with the use of eHealth in patients with type 2 diabetes and obesity: study protocol for a randomised controlled non-inferiority trial (E-diet trial).

BACKGROUND: Despite preventive measures, the number of people with type 2 diabetes and obesity is increasing. Obesity increases morbidity and mortality in people with type 2 diabetes, making weight loss a cornerstone of treatment. We previously developed a very low energy diet (VLED) intervention that effectively reduced weight in people with type 2 diabetes in the long term. However, this intervention requires considerable time and manpower, which reduces the number of people who can benefit from it. eHealth offers more efficient solutions but has proven to be less effective than face-to-face interventions. Therefore, we want to investigate whether a blended version of our VLED intervention (in which face-to-face contact is partly replaced by an eHealth (mobile) application (E-VLED)) would be more cost-effective than the current face-to-face intervention. METHODS: We will conduct a randomised, controlled trial with non-inferiority design in patients with type 2 diabetes and obesity (BMI > 30 kg/m2), aged 18-75 years. The control group will receive the usual care VLED intervention, while the intervention group will receive the E-VLED intervention for 1 year, where face-to-face contact will be partly replaced by an eHealth (mobile) application. The main study endpoint is the difference in weight (% change) between the control and intervention group after 1 year, plus the difference between the total costs (euro) of the treatment in the control and intervention groups. The secondary aims are to investigate the effectiveness of the E-VLED diet intervention regarding cardiovascular risk factors, quality of life, patient satisfaction, compliance, and to study whether there is a difference in effectiveness in pre-specified subgroups. General linear models for repeated measurements will be applied for the statistical analysis of the data. DISCUSSION: We hypothesise that the E-VLED intervention will be equally effective compared to the usual care VLED but lower in costs due to less time invested by the dietician. This will enable to help more people with type 2 diabetes and obesity to effectively lose weight and improve their health-related quality of life. TRIAL REGISTRATION: Netherlands Trial Register, NL7832, registered on 26 June 2019.

Determinants of dropout and compliance of children participating in a multidisciplinary intervention programme for overweight and obesity in socially deprived areas.

BACKGROUND: Children with overweight and obesity in socially deprived areas (SDAs) are less likely to complete and be compliant to a weight-loss programme. OBJECTIVES: To identify factors associated with dropout and compliance of a multidisciplinary weight-loss programme in SDA. METHODS: This prospective longitudinal cohort study included children (6-12 years) with overweight and obesity in a 12-week multidisciplinary intervention living in SDA in Rotterdam, the Netherlands. Potential predictive variables for dropout and compliance included were age, sex, the weight of the child and parents, quality of life, and referral status (self-registration or referral). A Cox proportional hazards model was performed to study the association between dropout and its potential predictive variables, whereas logistic regression analyses were used for the potential predictors for compliance. RESULTS: A total of 121 children started the intervention programme. Forty-one (33.9%) children dropped out and 68 (56.2%) were compliant with the intervention. The risk of dropping out of the intervention was significantly lower for a child with overweight parents than for those with parents with normal weight (adjusted hazard ratio [HR] 0.22 [95% confidence interval, CI 0.063-0.75]), and for those with parents with obesity (adjusted HR 0.18 [95% CI 0.060-0.52]). No other potential predictive variables were associated with dropout or compliance. CONCLUSION: Children from SDA participating in a weight-loss programme have a relatively high dropout and a low compliance rate. Parental weight seems to be an important predictor for dropout of children from SDA, where children with normal weight or obese parents have the highest risk of dropout compared with children of overweight parents.

Effectiveness and cost-effectiveness of a combined lifestyle intervention compared with usual care for patients with early-stage knee osteoarthritis who are overweight (LITE): protocol for a randomised controlled trial.

INTRODUCTION: Obesity is the most important modifiable risk factor for knee osteoarthritis (KOA). Especially in an early stage of the disease, weight loss is important to prevent further clinical and structural progression. Since 2019, general practitioners (GPs) in the Netherlands can refer eligible patients to a combined lifestyle intervention (GLI) to promote physical activity, healthy nutrition and behavioural change. However, GPs scarcely refer patients with KOA to the GLI potentially due to a lack of evidence about the (cost-)effectiveness. The aim of this study is to determine the (cost-)effectiveness of the GLI for patients with early-stage KOA in primary care. METHODS AND ANALYSIS: For this pragmatic, multi-centre randomised controlled trial, 234 participants (aged 45-70 years) with National Institute for Health and Care Excellence (NICE) guideline diagnosis of clinical KOA and a body mass index above 25 kg/m2 will be recruited using a range of online and offline strategies and from general practices in the Netherlands. Participants will receive nine 3-monthly questionnaires. In addition, participants will be invited for a physical examination, MRI assessment and blood collection at baseline and at 24-month follow-up. After the baseline assessment, participants are randomised to receive either the 24-month GLI programme in addition to usual care or usual care only. Primary outcomes are self-reported knee pain over 24 months, structural progression on MRI at 24 months, weight loss at 24 months, as well as societal costs and Quality-Adjusted Life-Years over 24-month follow-up. Analyses will be performed following the intention-to-treat principle using linear mixed-effects regression models. ETHICS AND DISSEMINATION: Ethical approval was obtained through the Medical Ethical Committee of the Erasmus MC University Medical Center Rotterdam, The Netherlands (MEC-2020-0943). All participants will provide written informed consent. The results will be disseminated through publications in peer-reviewed journals, presentations at international conferences and among study participants and healthcare professionals. TRIAL REGISTRATION NUMBER: Netherlands Trial Registry (NL9355).

The effect of a multidisciplinary intervention program for overweight and obese children on cardiorespiratory fitness and blood pressure.

BACKGROUND: Multidisciplinary intervention programs for overweight and obese children mainly focus on reducing bodyweight and body mass index (BMI), but they may also positively impact blood pressure (BP), and cardiorespiratory fitness (CRF), which is a stronger predictor for all-cause mortality than BMI. OBJECTIVE: To evaluate whether Kids4Fit, a multidisciplinary weight reduction program, has a positive effect on CRF and BP in overweight and obese children in socially deprived areas. METHODS: A quasi-experimental study design with a waiting list control period including children who participated in a multidisciplinary intervention program of 12 weeks was set-up. Blood pressure measurements and shuttle-run test (SRT) were performed at baseline, at the start of the intervention, at the end of intervention and after 52 weeks. The effect of Kids4Fit on BP and on SRT scores were analyzed using mixed models. RESULTS: A total of 154 children were included [mean age 8.5 years (SD 1.8)]. No significant change was seen in systolic BP percentiles at 52 weeks after start of the Kids4Fit intervention (ß 0.08, (95%CI -0.06, 0.22)). Diastolic BP percentiles increased significantly over time (ß 0.20 (0.08, 0.31)). Effect plots showed an initial significant increase of the SRT scores but this effect diluted after the intervention. CONCLUSION: A local multidisciplinary intervention program in deprived areas had a significant positive effect on CRF, but this effect diluted after the intervention. Diastolic BP percentiles significantly increased over time. However, systolic BP did not change over time.

A multidisciplinary intervention programme for overweight and obese children in deprived areas.

Background: GPs can refer obese children living in deprived areas to multidisciplinary programmes for a weight loss intervention, though the effectiveness of these local initiatives targeted to this specific group is unknown. Objective: To evaluate the effectiveness of the Kids4Fit intervention in deprived areas on child's weight status. Methods: Design and setting: cohort study, including a waiting list control period. Subjects: children (N = 154) aged 6-12 years, who signed up for the Kids4Fit intervention programme, led by a dietitian, physiotherapist and child psychologist were included. Measurements of standardized body mass index (BMI-z) and waist circumference were taken at start of the waiting list period, at start and at the end of the intervention and after 52 weeks. Mixed model analyses (random effects models) were used, expressed in effect per week [ß with 95% confidence interval (CI)], compared to the waiting list expectancy over the 52-week study period. Results: Mixed model analyses showed a non-significant trend towards a lower BMI-z up to 52 weeks after start of Kids4Fit (ß: -0.0024; 95% CI: -0.0053; 0.0004), compared to the waiting list expectancy. A significantly lower waist circumference was found over time compared to the waiting list expectancy (ß: -0.0558; 95% CI: -0.0950; -0.0166). No differences were found in lifestyle and health-related quality of life. Conclusion: A local multidisciplinary intervention programme in deprived areas is effective in reducing waist circumference of obese children, compared to a waiting list expectancy, but no significant changes in lifestyle and quality of life were shown.