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The goal of this clinical trial is to learn if lifestyle intervention with information about ketosis state supports weight reduction in overweight adults.
Researchers will compare an App-based lifestyle intervention with self-monitoring of breath acetone vs. lifestyle intervention alone.
Participants will:
Get a lifestyle intervention via the LIM-App for 12 months. Report body weight.
Background: Overweight and obesity are an increasing problem. 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, physical activity, self monitoring of weight, and self-monitoring of breath acetone (SMBA) is examined compared to a control group without information about ketosis level. Weight change will be compared after 3 and 12 months.
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 including information about ketosis level |
|
| control group | Active Comparator | lifestyle intervention without information about ketosis level |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| self-monitoring of breath acetone | Other | Participants perform self-monitoring of braeth acetone in order to get information about their ketosis state. |
|
| Measure | Description | Time Frame |
|---|---|---|
| body weight | body weight in kg | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| body weight | body weight in kg | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephan Martin | Contact | 049-2115660360 | 70 | stephan.martin@uni-duesseldorf.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West German Center of Diabetes and Health | Düsseldorf | 40591 | Germany |
upon request
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D015431 | Weight Loss |
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| lifestyle-intervention via LIM-App | Other | Participants are offered a lifestyle intervention via LIM-App. |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |