Overweight and Obesity
Conditions
Brief summary
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.
Interventions
BEHAVIORALTelemedical coaching
Individual telemedical coaching delivered by a nutritional consultant
BEHAVIORALLow-Insulin-Method
Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps
Sponsors
University of Bonn
West German Center of Diabetes and Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Body Mass Index 25 kg/m2
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight change in kg | 12 weeks | Estimated treatment difference |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| insulin in µU/ml | 12 weeks | Estimated treatment difference |
| HbA1c in % | 12 weeks | Estimated treatment difference |
| body mass index in kg/m2 | 12 weeks | Estimated treatment difference |
| waist circumference in cm | 12 weeks | Estimated treatment difference |
| hip circumference in cm | 12 weeks | Estimated treatment difference |
| fat mass in kg | 12 weeks | Estimated treatment difference |
| lean body mass in kg | 12 weeks | Estimated treatment difference |
| muscle mass in kg | 12 weeks | Estimated treatment difference |
| energy expenditure in kcal | 12 weeks | Estimated treatment difference |
| blood pressure in mmHg | 12 weeks | Estimated treatment difference |
| depression (German version of the Center for Epidemiological Studies-Depression Scale) in units on a scale | 12 weeks | Estimated treatment difference minimum 0, maximum 100 higher scores mean a worse outcome |
| physical activity in min/day | 12 weeks | Estimated treatment difference |
| physical activity in steps/day | 12 weeks | Estimated treatment difference |
| eating behaviour (German version of the Three-factor Eating Questionnaire) in units on a scale | 12 weeks | Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome |
| total cholesterol in mg/dl | 12 weeks | Estimated treatment difference |
| HDL cholesterol in mg/dl | 12 weeks | Estimated treatment difference |
| LDL cholesterol in mg/dl | 12 weeks | Estimated treatment difference |
| triglycerides in mg/dl | 12 weeks | Estimated treatment difference |
| fasting blood glucose in mg/dl | 12 weeks | Estimated treatment difference |
| food frequency (German version of the food frequency questionnaire) in units on a scale | 12 weeks | Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome |
| quality of life (short form questionnaire) in units on a scale | 12 weeks | Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome |
Other
| Measure | Time frame | Description |
|---|---|---|
| gut microbiome composition in percent | 12 weeks | difference between groups |
Countries
Germany
Outcome results
None listed