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Completed

NCT Number: NCT03417674

SHAPE AND MOTION - Medical Accompanied Slimming

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.

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West-German Centre of Diabetes and Health

Düsseldorf, 40591, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle intervention

Combination Product

Meal replacement by formula diet, exercise stimulation, and telemedicine coaching.

Primary outcomes

  1. Weight loss in kg

    Time frame: 26 weeks

    Estimated treatment difference

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

West German Center of Diabetes and Health

Other

Registry information

Acronym: SAMMAS

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 31, 2018
Registry last updated
Oct 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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