Efficiency of a blended care version of an effective diabetes diet

Efficiency of a blended care version of an effective diabetes diet: a randomised, controlled non-inferiority trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29277

Enrollment

200

Registered

2019-06-26

Start date

2021-03-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus

Interventions

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 par

Eligibility

Inclusion criteria

Inclusion criteria: • Type 2 Diabetes • Age 18-75 years • Obesity (BMI>30 kg/m2) • Smartphone with Android or iOS

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
- 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).	—

Measure

Time frame

- 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).

—

Contacts

Public ContactKirsten Berk

Erasmus MC

k.berk@erasmusmc.nl0617512121

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)