No registrations found.
ID
Source
Brief title
Health condition
Type 2 diabetes mellitus
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
- Quality of life, measured with the EuroQol vragenlijst EQ-5L
- Cardiovascular risk factors: Blood pressure (mmHg), total cholesterol (mmol/l), LDL cholesterol (mmol/l), HDL cholesterol (mmol/l), triglycerides (mmol/l), HbA1c (mmol/mol), fasting bloodglucose (mmol/l), all measured via routine clinical care/lab
- Food intake (dietary history)
- Body composition: waist circumference (cm), and fat mass and lean body mass measurement via Bio-electrical Impedance Analysis (bodystat quadscan 4000, Euromedix, Leuven, Belgium)
- Resting Energy Expenditure (Via Quark RMR, Cosmed Benelux B.V., Nieuwegein, The Netherlands)
- Patient satisfaction, measured via the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
- Attitudes towards using e-health (general and specific for this diet app) to access health information, measured via the e-Health Impact Questionnaire (EHIQ)
- Depression and anxiety via the Hospital Anxiety and Depression Scale (HADS)
- Compliance and attrition (number of participants that drop-out and log-on information).
Background summary
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.
Study objective
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.
Study design
Baseline - 2months - 4 months - 1 year
Intervention
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.
Inclusion criteria
• Type 2 Diabetes
• Age 18-75 years
• Obesity (BMI>30 kg/m2)
• Smartphone with Android or iOS
Exclusion criteria
• Pregnancy or lactation during the trial
• Severe psychiatric problems, use of antipsychotic drugs
• Significant cardiac arrhythmias; unstable angina; decompensated congestive heart failure; carcinomas; major organ system failure; untreated hypothyroidism; end-stage renal disease;
• Myocardial infarction, cerebrovascular accident or major surgery during the previous 3 months.
• Corticosteroid induced diabetes (in patients still using corticosteroids)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7832 |
| CCMO | NL69176.078.19 |
| OMON | NL-OMON56623 |