SHAPE AND MOTION - Medical Accompanied Slimming (SAMMAS)

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Combination product: Lifestyle intervention

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Düsseldorf, Germany, 40591
    • West-German Centre of Diabetes and Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Lifestyle intervention with meal replacement by formula diet, exercise stimulation, and telemedicine coaching.	Combination product: Lifestyle intervention; Meal replacement by formula diet, exercise stimulation, and telemedicine coaching.
No Intervention: Control group; Routine care.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: West German Center of Diabetes and Health
• Investigators: Principal Investigator: Stephan Martin, MD, West-German Centre of Diabetes and Health

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2018
• Primary Completion (Actual): April 10, 2019
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 31, 2018

Study Record Updates

• Last Update Posted (Actual): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: FORM UND BEWEGUNG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No