SHAPE AND MOTION - Medical Accompanied Slimming

Overweight and Obesity Clinical Trial

— SAMMAS  

Official title:

SHAPE AND MOTION - Medical Accompanied Slimming

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03417674
• Other study ID #: FORM UND BEWEGUNG
• Status: Completed
• Phase: N/A
• Start date: February 10, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2021
• Source: West German Center of Diabetes and Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: April 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Combination Product:
• Lifestyle intervention
Meal replacement by formula diet, exercise stimulation, and telemedicine coaching.

Locations

Country	Name	City	State
Germany	West-German Centre of Diabetes and Health	Düsseldorf

Sponsors (1)

Lead Sponsor	Collaborator
West German Center of Diabetes and Health

Country where clinical trial is conducted

Germany, 

Outcome

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