SHAPE AND MOTION - Medical Accompanied Slimming (SAMMAS)
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Lifestyle intervention
Sponsored by

About this trial
This is an interventional prevention trial for Overweight and Obesity
Eligibility Criteria
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
Sites / Locations
- West-German Centre of Diabetes and Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Lifestyle intervention with meal replacement by formula diet, exercise stimulation, and telemedicine coaching.
Routine care.
Outcomes
Primary Outcome Measures
Weight loss in kg
Estimated treatment difference
Secondary Outcome Measures
body mass index in kg/m2
Estimated treatment difference
waist circumference in cm
Estimated treatment difference
hip circumference in cm
Estimated treatment difference
fat mass in kg
Estimated treatment difference
lean body mass in kg
Estimated treatment difference
muscle mass in kg
Estimated treatment difference
energy expenditure in kcal
Estimated treatment difference
blood pressure in mmHg
Estimated treatment difference
quality of life (sf-12 questionnaire) in units on a scale
Estimated treatment difference
depression (German version of the Center for Epidemiological Studies-Depression [CES-D] Scale) in units on a scale
Estimated treatment difference
physical activity in min/day
Estimated treatment difference
physical activity in steps/day
Estimated treatment difference
eating behaviour (German version of the Three-factor Eating Questionnaire [TFEQ]) in units on a scale
Estimated treatment difference
total cholesterol in mg/dl
Estimated treatment difference
HDL cholesterol in mg/dl
Estimated treatment difference
LDL cholesterol in mg/dl
Estimated treatment difference
triglycerides in mg/dl
Estimated treatment difference
fasting blood glucose in mg/dl
Estimated treatment difference
insulin in µU/ml
Estimated treatment difference
HbA1c in %
Estimated treatment difference
uric acid in mg/dl
Estimated treatment difference
creatinin in mg/dl
Estimated treatment difference
medication in mg/day
Estimated treatment difference
Full Information
NCT ID
NCT03417674
First Posted
January 9, 2018
Last Updated
October 11, 2021
Sponsor
West German Center of Diabetes and Health
1. Study Identification
Unique Protocol Identification Number
NCT03417674
Brief Title
SHAPE AND MOTION - Medical Accompanied Slimming
Acronym
SAMMAS
Official Title
SHAPE AND MOTION - Medical Accompanied Slimming
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 10, 2018 (Actual)
Primary Completion Date
April 10, 2019 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
West German Center of Diabetes and Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Lifestyle intervention with meal replacement by formula diet, exercise stimulation, and telemedicine coaching.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Routine care.
Intervention Type
Combination Product
Intervention Name(s)
Lifestyle intervention
Intervention Description
Meal replacement by formula diet, exercise stimulation, and telemedicine coaching.
Primary Outcome Measure Information:
Title
Weight loss in kg
Description
Estimated treatment difference
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
body mass index in kg/m2
Description
Estimated treatment difference
Time Frame
26 weeks
Title
waist circumference in cm
Description
Estimated treatment difference
Time Frame
26 weeks
Title
hip circumference in cm
Description
Estimated treatment difference
Time Frame
26 weeks
Title
fat mass in kg
Description
Estimated treatment difference
Time Frame
26 weeks
Title
lean body mass in kg
Description
Estimated treatment difference
Time Frame
26 weeks
Title
muscle mass in kg
Description
Estimated treatment difference
Time Frame
26 weeks
Title
energy expenditure in kcal
Description
Estimated treatment difference
Time Frame
26 weeks
Title
blood pressure in mmHg
Description
Estimated treatment difference
Time Frame
26 weeks
Title
quality of life (sf-12 questionnaire) in units on a scale
Description
Estimated treatment difference
Time Frame
26 weeks
Title
depression (German version of the Center for Epidemiological Studies-Depression [CES-D] Scale) in units on a scale
Description
Estimated treatment difference
Time Frame
26 weeks
Title
physical activity in min/day
Description
Estimated treatment difference
Time Frame
26 weeks
Title
physical activity in steps/day
Description
Estimated treatment difference
Time Frame
26 weeks
Title
eating behaviour (German version of the Three-factor Eating Questionnaire [TFEQ]) in units on a scale
Description
Estimated treatment difference
Time Frame
26 weeks
Title
total cholesterol in mg/dl
Description
Estimated treatment difference
Time Frame
26 weeks
Title
HDL cholesterol in mg/dl
Description
Estimated treatment difference
Time Frame
26 weeks
Title
LDL cholesterol in mg/dl
Description
Estimated treatment difference
Time Frame
26 weeks
Title
triglycerides in mg/dl
Description
Estimated treatment difference
Time Frame
26 weeks
Title
fasting blood glucose in mg/dl
Description
Estimated treatment difference
Time Frame
26 weeks
Title
insulin in µU/ml
Description
Estimated treatment difference
Time Frame
26 weeks
Title
HbA1c in %
Description
Estimated treatment difference
Time Frame
26 weeks
Title
uric acid in mg/dl
Description
Estimated treatment difference
Time Frame
26 weeks
Title
creatinin in mg/dl
Description
Estimated treatment difference
Time Frame
26 weeks
Title
medication in mg/day
Description
Estimated treatment difference
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Martin, MD
Organizational Affiliation
West-German Centre of Diabetes and Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
West-German Centre of Diabetes and Health
City
Düsseldorf
ZIP/Postal Code
40591
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SHAPE AND MOTION - Medical Accompanied Slimming
We'll reach out to this number within 24 hrs