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SHAPE AND MOTION - Medical Accompanied Slimming (SAMMAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03417674
Recruitment Status : Active, not recruiting
First Posted : January 31, 2018
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Overweight and Obesity Combination Product: Lifestyle intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: SHAPE AND MOTION - Medical Accompanied Slimming
Actual Study Start Date : February 10, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : May 31, 2020

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.



Primary Outcome Measures :
  1. Weight loss in kg [ Time Frame: 26 weeks ]
    Estimated treatment difference


Secondary Outcome Measures :
  1. body mass index in kg/m2 [ Time Frame: 26 weeks ]
    Estimated treatment difference

  2. waist circumference in cm [ Time Frame: 26 weeks ]
    Estimated treatment difference

  3. hip circumference in cm [ Time Frame: 26 weeks ]
    Estimated treatment difference

  4. fat mass in kg [ Time Frame: 26 weeks ]
    Estimated treatment difference

  5. lean body mass in kg [ Time Frame: 26 weeks ]
    Estimated treatment difference

  6. muscle mass in kg [ Time Frame: 26 weeks ]
    Estimated treatment difference

  7. energy expenditure in kcal [ Time Frame: 26 weeks ]
    Estimated treatment difference

  8. blood pressure in mmHg [ Time Frame: 26 weeks ]
    Estimated treatment difference

  9. quality of life (sf-12 questionnaire) in units on a scale [ Time Frame: 26 weeks ]
    Estimated treatment difference

  10. 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

  11. physical activity in min/day [ Time Frame: 26 weeks ]
    Estimated treatment difference

  12. physical activity in steps/day [ Time Frame: 26 weeks ]
    Estimated treatment difference

  13. eating behaviour (German version of the Three-factor Eating Questionnaire [TFEQ]) in units on a scale [ Time Frame: 26 weeks ]
    Estimated treatment difference

  14. total cholesterol in mg/dl [ Time Frame: 26 weeks ]
    Estimated treatment difference

  15. HDL cholesterol in mg/dl [ Time Frame: 26 weeks ]
    Estimated treatment difference

  16. LDL cholesterol in mg/dl [ Time Frame: 26 weeks ]
    Estimated treatment difference

  17. triglycerides in mg/dl [ Time Frame: 26 weeks ]
    Estimated treatment difference

  18. fasting blood glucose in mg/dl [ Time Frame: 26 weeks ]
    Estimated treatment difference

  19. insulin in µU/ml [ Time Frame: 26 weeks ]
    Estimated treatment difference

  20. HbA1c in % [ Time Frame: 26 weeks ]
    Estimated treatment difference

  21. uric acid in mg/dl [ Time Frame: 26 weeks ]
    Estimated treatment difference

  22. creatinin in mg/dl [ Time Frame: 26 weeks ]
    Estimated treatment difference

  23. medication in mg/day [ Time Frame: 26 weeks ]
    Estimated treatment difference



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417674


Locations
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Germany
West-German Centre of Diabetes and Health
Düsseldorf, Germany, 40591
Sponsors and Collaborators
West German Center of Diabetes and Health
Investigators
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Principal Investigator: Stephan Martin, MD West-German Centre of Diabetes and Health
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Responsible Party: West German Center of Diabetes and Health
ClinicalTrials.gov Identifier: NCT03417674    
Other Study ID Numbers: FORM UND BEWEGUNG
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms