Weight Reduction With the Low-Insulin-Method

Study Overview
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Brief Summary
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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.

Official Title
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Weight Reduction With the Low-Insulin-Method in an Occupational Health Setting

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: Telemedical coaching
* Behavioral: Low-Insulin-Method


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index 25 kg/m2 Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps, and telemedical coaching. | Behavioral: Telemedical coaching<br>* Individual telemedical coaching delivered by a nutritional consultant<br>Behavioral: Low-Insulin-Method<br>* Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps<br>|
| Active Comparator: Control group<br>Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps. | Behavioral: Low-Insulin-Method<br>* Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change in kg | Estimated treatment difference | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body mass index in kg/m2 | Estimated treatment difference | 12 weeks | 
| waist circumference in cm | Estimated treatment difference | 12 weeks | 
| 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 |