SHAPE AND MOTION - Medical Accompanied Slimming

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 scientifically evaluated program SHAPE AND MOTION - medically ◦ accompanied ◦ slimming was developed to support overweight and obese people in weight loss. Method: In a randomized controlled clinical trial, the effect of a lifestyle intervention with meal replacement by formula diet, exercise stimulation, and telemedicine coaching is examined compared to a control group with routine care. The learning contents are taught in 7 group trainings, a practical unit with shopping and cooking training, as well as in 4 individual telephone conversations. The state of health is examined at the beginning, after 12 and 26 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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SHAPE AND MOTION - Medical Accompanied Slimming

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Combination Product: Lifestyle intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index ≥ 25 kg/m2 Exclusion Criteria: acute diseases such as respiratory or gastrointestinal infections severe diseases such as tumors, chronic obstructive pulmonary disease (COPD), asthma, dementia, chronic bowel disease, psychosis, liver cirrhosis, (macro) nephropathy, renal insufficiency with glomerular filtration rate (GFR) <30 ongoing chemotherapy, chron. Cortisone treatment

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: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Lifestyle intervention with meal replacement by formula diet, exercise stimulation, and telemedicine coaching. | Combination Product: Lifestyle intervention<br>* Meal replacement by formula diet, exercise stimulation, and telemedicine coaching.<br>|
| No Intervention: Control group<br>Routine care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss in kg | Estimated treatment difference | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body mass index in kg/m2 | Estimated treatment difference | 26 weeks | 
| waist circumference in cm | Estimated treatment difference | 26 weeks | 
| hip circumference in cm | Estimated treatment difference | 26 weeks | 
| fat mass in kg | Estimated treatment difference | 26 weeks | 
| lean body mass in kg | Estimated treatment difference | 26 weeks | 
| muscle mass in kg | Estimated treatment difference | 26 weeks | 
| energy expenditure in kcal | Estimated treatment difference | 26 weeks | 
| blood pressure in mmHg | Estimated treatment difference | 26 weeks | 
| quality of life (sf-12 questionnaire) in units on a scale | Estimated treatment difference | 26 weeks | 
| depression (German version of the Center for Epidemiological Studies-Depression [CES-D] Scale) in units on a scale | Estimated treatment difference | 26 weeks | 
| physical activity in min/day | Estimated treatment difference | 26 weeks | 
| physical activity in steps/day | Estimated treatment difference | 26 weeks | 
| eating behaviour (German version of the Three-factor Eating Questionnaire [TFEQ]) in units on a scale | Estimated treatment difference | 26 weeks | 
| total cholesterol in mg/dl | Estimated treatment difference | 26 weeks | 
| HDL cholesterol in mg/dl | Estimated treatment difference | 26 weeks | 
| LDL cholesterol in mg/dl | Estimated treatment difference | 26 weeks | 
| triglycerides in mg/dl | Estimated treatment difference | 26 weeks | 
| fasting blood glucose in mg/dl | Estimated treatment difference | 26 weeks | 
| insulin in µU/ml | Estimated treatment difference | 26 weeks | 
| HbA1c in % | Estimated treatment difference | 26 weeks | 
| uric acid in mg/dl | Estimated treatment difference | 26 weeks | 
| creatinin in mg/dl | Estimated treatment difference | 26 weeks | 
| medication in mg/day | Estimated treatment difference | 26 weeks |