eSupported lifestyle coaching for patients with insulin dependent type 2 diabetes mellitus: a pilot study
- Conditions
- Diabetes mellitus type 2100184241002914910024450
- Registration Number
- NL-OMON42730
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 11
Insulin-dependent Type 2 Diabetes Mellitus patients. The goal is to include at least 6 of the 12 patients with kidney damage, with eGFR < 60 ml/min/1,73m2 (CKD-EPI) and/or albumin/creatinin ratio > 2,5 mg/mmol (men) or 3,5 mg/mmol (women).
• Recent (< 3 months) myocardial infarction
• Uncontrolled blood pressure (SBP > 170 mmHg and/or DBP > 100 mmHg, 2 out of 3 measurements)
• Any chronic disease other than type 2 diabetes hampering participation (at the discretion of the investigator)
• Low motivation to participate (score 2 *weak* or 1 *very weak* on a 5-point scale).
• Alcohol consumption of more than 28 units per week at present or in the past
• Psychiatric disease (as defined by DSM-V)
• Claustrophobia, metal implants or other contraindications for cardiac MRI
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameter/endpoint<br /><br>• Feasibility and sustainability of the proposed healthy lifestyle behaviors,<br /><br>measured with 24-hour recall dietary diary, plus validated self-report on<br /><br>physical activity and stress management activities (Ornish 1998).<br /><br>• Attractiveness of the eSupport Lifestyle Intervention, measured via patient<br /><br>satisfaction and the Technology Acceptance Model (TAM; Szajna 1996) on weeks 4,<br /><br>12, 50.</p><br>
- Secondary Outcome Measures
Name Time Method