SHAPE AND MOTION - Medical Accompanied Slimming
- Conditions
- Overweight and Obesity
- Interventions
- Combination Product: Lifestyle intervention
- Registration Number
- NCT03417674
- Lead Sponsor
- West German Center of Diabetes and Health
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Body mass index ≥ 25 kg/m2
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Intervention group Lifestyle intervention Lifestyle intervention with meal replacement by formula diet, exercise stimulation, and telemedicine coaching.
- Primary Outcome Measures
Name Time Method Weight loss in kg 26 weeks Estimated treatment difference
- Secondary Outcome Measures
Name Time Method triglycerides in mg/dl 26 weeks Estimated treatment difference
uric acid in mg/dl 26 weeks Estimated treatment difference
lean body mass in kg 26 weeks Estimated treatment difference
energy expenditure in kcal 26 weeks Estimated treatment difference
body mass index in kg/m2 26 weeks Estimated treatment difference
waist circumference in cm 26 weeks Estimated treatment difference
muscle mass in kg 26 weeks Estimated treatment difference
blood pressure in mmHg 26 weeks Estimated treatment difference
quality of life (sf-12 questionnaire) in units on a scale 26 weeks Estimated treatment difference
total cholesterol in mg/dl 26 weeks Estimated treatment difference
fasting blood glucose in mg/dl 26 weeks Estimated treatment difference
HbA1c in % 26 weeks Estimated treatment difference
physical activity in min/day 26 weeks Estimated treatment difference
fat mass in kg 26 weeks Estimated treatment difference
hip circumference in cm 26 weeks Estimated treatment difference
depression (German version of the Center for Epidemiological Studies-Depression [CES-D] Scale) in units on a scale 26 weeks Estimated treatment difference
physical activity in steps/day 26 weeks Estimated treatment difference
LDL cholesterol in mg/dl 26 weeks Estimated treatment difference
insulin in µU/ml 26 weeks Estimated treatment difference
eating behaviour (German version of the Three-factor Eating Questionnaire [TFEQ]) in units on a scale 26 weeks Estimated treatment difference
HDL cholesterol in mg/dl 26 weeks Estimated treatment difference
creatinin in mg/dl 26 weeks Estimated treatment difference
medication in mg/day 26 weeks Estimated treatment difference
Trial Locations
- Locations (1)
West-German Centre of Diabetes and Health
🇩🇪Düsseldorf, Germany