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)

Trials

Study Protocol

Joost van Rosmalen¹  Behiye Ozcan²  Mandy van Hoek²  Kirsten A. Berk³  Karlijn A. M. Geurts³  Elisabeth F. C. van Rossum⁴  Roel van de Laar⁵  Jolande van Teeffelen⁶ 

[1] Department of Biostatistics, Erasmus MC, University Medical Center, Rotterdam, The Netherlands;Department of Epidemiology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands;Department of Internal Medicine, Division of Diabetology and Division of Vascular Medicine, Erasmus MC, University Medical Center, Rotterdam, The Netherlands;Department of Internal Medicine, Division of Dietetics, Erasmus MC, University Medical Center, Rotterdam, The Netherlands;Department of Internal Medicine, Division of Endocrinology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands;Division of Endocrinology, Obesity Center CGG, Erasmus MC, University Medical Center, Rotterdam, The Netherlands;Department of Internal Medicine, Ikazia Hospital, Montessoriweg 1, 3083 AN, Rotterdam, The Netherlands;Dietician Practice Health Risk Control, Henk Speksnijderstraat 27, 3067 AC, Rotterdam, The Netherlands;

关键词: Type 2 diabetes;    Overweight;    Obesity;    Diet;    Very low energy diet;    eHealth;    Mobile application;    Blended care;    Non-inferiority;   

DOI  :  10.1186/s13063-023-07620-6

 received in 2022-12-01, accepted in 2023-09-04,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundDespite 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.MethodsWe 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.DiscussionWe 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 registrationNetherlands Trial Register, NL7832, registered on 26 June 2019.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

【 图 表 】

Fig. 4