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| Name | Class |
|---|---|
| University of Bonn | OTHER |
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Background: Overweight and obesity affect health, quality of life and ability to work. Therefore, the Low-Insulin-Method was developed to support overweight and obese people in weight loss.
Method: In a randomized controlled clinical trial, the effect of the lifestyle intervention program 'Low-Insulin-Method', delivered by the Low-Insulin-App including low-carb diet, self monitoring of weight, physical activity and telemedical coaching is examined compared to a control group without coaching. The learning contents are taught in 30 videos and 5 online meetings. The intervention group additionally gets 4 individual care calls. The state of health is examined at the beginning and after 12 weeks.
Objective: The aim is to develop a training and counseling program for overweight or obese individuals with diabetes risk or type 2 diabetes, which can be used both for primary and for tertiary prevention of overweight-related diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps, and telemedical coaching. |
|
| Control group | Active Comparator | Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedical coaching | Behavioral | Individual telemedical coaching delivered by a nutritional consultant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight change in kg | Estimated treatment difference | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| body mass index in kg/m2 | Estimated treatment difference | 12 weeks |
| waist circumference in cm | Estimated treatment difference | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| gut microbiome composition in percent | difference between groups | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West German Centre of Diabetes and Health | Düsseldorf | 40591 | Germany |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Low-Insulin-Method | Behavioral | Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps |
|
| hip circumference in cm | Estimated treatment difference | 12 weeks |
| fat mass in kg | Estimated treatment difference | 12 weeks |
| lean body mass in kg | Estimated treatment difference | 12 weeks |
| muscle mass in kg | Estimated treatment difference | 12 weeks |
| energy expenditure in kcal | Estimated treatment difference | 12 weeks |
| blood pressure in mmHg | Estimated treatment difference | 12 weeks |
| quality of life (short form questionnaire) in units on a scale | Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome | 12 weeks |
| depression (German version of the Center for Epidemiological Studies-Depression Scale) in units on a scale | Estimated treatment difference minimum 0, maximum 100 higher scores mean a worse outcome | 12 weeks |
| physical activity in min/day | Estimated treatment difference | 12 weeks |
| physical activity in steps/day | Estimated treatment difference | 12 weeks |
| eating behaviour (German version of the Three-factor Eating Questionnaire) in units on a scale | Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome | 12 weeks |
| total cholesterol in mg/dl | Estimated treatment difference | 12 weeks |
| HDL cholesterol in mg/dl | Estimated treatment difference | 12 weeks |
| LDL cholesterol in mg/dl | Estimated treatment difference | 12 weeks |
| triglycerides in mg/dl | Estimated treatment difference | 12 weeks |
| fasting blood glucose in mg/dl | Estimated treatment difference | 12 weeks |
| insulin in µU/ml | Estimated treatment difference | 12 weeks |
| HbA1c in % | Estimated treatment difference | 12 weeks |
| food frequency (German version of the food frequency questionnaire) in units on a scale | Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome | 12 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |