'Diabetescoach' – personal health coaching in patients with type 2 diabetes mellitus

Not Applicable

Completed

Conditions: Type 2 diabetes
Nutritional, Metabolic, Endocrine
Type 2 diabetes mellitus

Registration Number: ISRCTN79457541

Lead Sponsor: niversity of Basel

Brief Summary: 2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35649615/ (added 08/06/2022)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 90

Inclusion Criteria

Current inclusion criteria as of 15/06/2021:
Type 2 diabetes patients will be included in the study if they:
1. Have an HbA1c value above 7.5
2. Have type 2 diabetes as defined by the American Diabetes Association
3. Are able to understand German at a sufficient level to comprehend instructions and information
4. Have access to ongoing treatment for type 2 diabetes by a primary care physician or diabetologist
5. Have an Internet connection
6. Have an activity level of less than 150 minutes of moderate or 75 minutes of intensive physical activity per week

Previous inclusion criteria:
Type 2 diabetes patients will be included in the study if they:
1. Are between 18-65 years old
2. Have an HbA1c value above 7.5
3. Have type 2 diabetes as defined by the American Diabetes Association
4. Are able to understand German at a sufficient level to comprehend instructions and information
5. Have access to ongoing treatment for type 2 diabetes by a primary care physician or diabetologist
6. Have an Internet connection
7. Have an activity level of less than 150 minutes of moderate or 75 minutes of intensive physical activity per week

Exclusion Criteria

Patients with type 2 diabetes must be excluded from the study if:
1. They have chronic or acute contraindications to physical activity or cannot be physically active for other medical reasons
2. They suffer from psychiatric or addiction disorders
3. They are pregnant
4. Insulin therapy is being used
5. If the HbA1c value cannot be reliably determined due to medical conditions (in the case of hemoglobinopathy, hemolytic anemia, blood transfusion, HIV, liver or kidney failure requiring dialysis)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measured at baseline (T0), after study inclusion, 6 months after study inclusion (T1), and 12 months after study inclusion (T2):<br>1. Chronic glycemic control over the last 3 months measured using HbA1c blood marker<br>2. Duration and intensity of daily physical activity measured using a triaxial accelerometer (ActiGraph wGT3X-BT) around the waist for 7 days

Secondary Outcome Measures

Name	Time	Method
Measured at baseline (T0), after study inclusion, 6 months after study inclusion (T1), and 12 months after study inclusion (T2):<br>1. Subjective physical activity measured using SIMPAQ questionnaire<br>2. Nutrition and dietary behavior measured using Nutrition Diary, SEV questionnaire<br>3. Sport-related cognitive mediators of behavior change measured using questionnaires<br>4. Quality of life measured using SF-8 questionnaire<br>5. Neuropathy measured using FACT questionnaire<br>6. Medication measured using medical report<br>7. Food supplements measured using medical report<br>8. Anthropometry (abdominal circumference, hip circumference, height, weight) measured using medical report<br>9. Blood levels (cholesterol, LDL, non-HDL, Chol/HDL, CRP, IFG) measured using medical report<br>10. Comorbidities measured using medical report<br>11. Demographic variables measured using a demographic questionnaire<br>12. Cost-effectiveness measured using Swiss Medical Association, Tarmed V.1.09 at the end of the study