SEARCHOTHERendocrinology, nutrition

other·endocrinology, nutrition, dietetics, clinical nutrition, internal medicine·PMC10557281

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 · 8 authors, 8 centres

AI SUMMARY

FIDELITY 100%

This summary was generated by AI from a single paper. It has not been reviewed by a clinician and is not clinical advice. Verify against the source before acting on it.

AGENT 01 · STRUCTURED SUMMARY

TRACE TO SOURCE

“

TL;DR

The primary aim is to test if the eHealth version is non-inferior for weight loss at one year while being more cost-effective.

Full summary

575 CHARS

The primary endpoint is the between-group difference in percentage weight change at 12 months, with a non-inferiority margin of 3.0%. Statistical analysis will use general linear models for repeated measurements. The authors hypothesise the eHealth intervention will be equally effective but more cost-efficient due to reduced dietitian time. A noted limitation is the inability to blind participants and dietitians, and the study uses intermediate outcomes rather than hard clinical endpoints. The trial is registered (NL7832) and was approved by a medical ethics committee.

STUDY TYPE

other

SPECIALTY

endocrinology

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10557281

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

READ THE FULL PAPER

ABSTRACT

Abstract 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/m 2 ), 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. Keywords: Type 2 diabetes, Overweight, Obesity, Diet, Very low energy diet, eHealth, Mobile application, Blended care, Non-inferiority

CITATION EXPORT

Karlijn A M Geurts, Behiye Ozcan, Mandy van Hoek et al.. 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. (2023). https://doi.org/10.1186/s13063-023-07620-6

AUTHORS

8 · 8 CENTRES

Karlijn A M Geurts, Behiye Ozcan, Mandy van Hoek, Roel van de Laar, Jolande van Teeffelen, Joost van Rosmalen, Elisabeth F C van Rossum, Kirsten A Berk

1Department of Internal Medicine, Division of Dietetics, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
2Department of Internal Medicine, Division of Diabetology and Division of Vascular Medicine, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
3Department of Internal Medicine, Ikazia Hospital, Montessoriweg 1, 3083 AN Rotterdam, The Netherlands
4Dietician Practice Health Risk Control, Henk Speksnijderstraat 27, 3067 AC Rotterdam, The Netherlands
5Department of Biostatistics, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
6Department of Epidemiology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
7Department of Internal Medicine, Division of Endocrinology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands
8Division of Endocrinology, Obesity Center CGG, Erasmus MC, University Medical Center, Rotterdam, The Netherlands