Efficiency of a blended care version of an effective diabetes diet

Rationale: 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, therefore weight loss is a cornerstone of treatment. We previously developed a diet program (POWER diet) that effectively reduced weight in people with type 2 diabetes in the long term. In order to help more people, we aim to develop a blended care version of our diet, in which face-to-face contact is combined with e-health solutions.
Objective: The primary aim of the current study is to determine the efficiency of a blended care version of the POWER diet (‘Blended POWER’): whether it is equally effective in reducing weight while lower in costs, compared to the ‘usual care’ POWER diet. The secondary aims are to investigate the effectiveness of Blended POWER with regard to cardiovascular risk factors and quality of life, and to evaluate patient satisfaction, compliance, and to study whether there is a difference in effectivity and patient satisfaction when categorizing the group in males and females and in participants of Dutch or other origin.
Study design: Randomised, controlled trial with non-inferiority design.
Study population: Adults with type 2 diabetes, aged 18-75, with BMI>30 kg/m2.
Intervention: The control group will receive the standard of care POWER diet intervention program during 1 year, the intervention group will receive the Blended POWER intervention. In the Blended POWER intervention, the face-to-face contact will be partly replaced by an e-health application.
Main study parameters/endpoints: The main study endpoint is the difference in weight (kg) between the control and intervention group after 1 year, plus the difference between the total costs of the treatment in the control and intervention groups in euro’s.

We hypothesize that a blended care (combination of face-to-face treatment with e-health solutions) version of a very low-calorie weight loss intervention, is as (cost)effective as the usual care (face-to-face only) very low-calorie weight loss intervention in people with type 2 diabetes and overweight.

Baseline - 2months - 4 months - 1 year

The control group will receive the usual care diet intervention program during 1 year, the intervention group will receive the blended care diet intervention where the face-to-face contact will be partly replaced by an e-health application.