SHAPE AND MOTION - Medical Accompanied Slimming (SAMMAS)

October 11, 2021 updated by: West German Center of Diabetes and Health

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weight loss in kg
Time Frame: 26 weeks
Estimated treatment difference
26 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
body mass index in kg/m2
Time Frame: 26 weeks
Estimated treatment difference
26 weeks
waist circumference in cm
Time Frame: 26 weeks
Estimated treatment difference
26 weeks
hip circumference in cm
Time Frame: 26 weeks
Estimated treatment difference
26 weeks
fat mass in kg
Time Frame: 26 weeks
Estimated treatment difference
26 weeks
lean body mass in kg
Time Frame: 26 weeks
Estimated treatment difference
26 weeks
muscle mass in kg
Time Frame: 26 weeks
Estimated treatment difference
26 weeks
energy expenditure in kcal
Time Frame: 26 weeks
Estimated treatment difference
26 weeks
blood pressure in mmHg
Time Frame: 26 weeks
Estimated treatment difference
26 weeks
quality of life (sf-12 questionnaire) in units on a scale
Time Frame: 26 weeks
Estimated treatment difference
26 weeks
depression (German version of the Center for Epidemiological Studies-Depression [CES-D] Scale) in units on a scale
Time Frame: 26 weeks
Estimated treatment difference
26 weeks
physical activity in min/day
Time Frame: 26 weeks
Estimated treatment difference
26 weeks
physical activity in steps/day
Time Frame: 26 weeks
Estimated treatment difference
26 weeks
eating behaviour (German version of the Three-factor Eating Questionnaire [TFEQ]) in units on a scale
Time Frame: 26 weeks
Estimated treatment difference
26 weeks
total cholesterol in mg/dl
Time Frame: 26 weeks
Estimated treatment difference
26 weeks
HDL cholesterol in mg/dl
Time Frame: 26 weeks
Estimated treatment difference
26 weeks
LDL cholesterol in mg/dl
Time Frame: 26 weeks
Estimated treatment difference
26 weeks
triglycerides in mg/dl
Time Frame: 26 weeks
Estimated treatment difference
26 weeks
fasting blood glucose in mg/dl
Time Frame: 26 weeks
Estimated treatment difference
26 weeks
insulin in µU/ml
Time Frame: 26 weeks
Estimated treatment difference
26 weeks
HbA1c in %
Time Frame: 26 weeks
Estimated treatment difference
26 weeks
uric acid in mg/dl
Time Frame: 26 weeks
Estimated treatment difference
26 weeks
creatinin in mg/dl
Time Frame: 26 weeks
Estimated treatment difference
26 weeks
medication in mg/day
Time Frame: 26 weeks
Estimated treatment difference
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
West German Center of Diabetes and Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephan Martin, MD, West-German Centre of Diabetes and Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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