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SHAPE AND MOTION - Medical Accompanied Slimming (SAMMAS)

W

West German Center of Diabetes and Health

Status

Completed

Conditions

Overweight and Obesity

Treatments

Combination Product: Lifestyle intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT03417674
FORM UND BEWEGUNG

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Single Blind

30 participants in 2 patient groups

Intervention group
Experimental group
Description:
Lifestyle intervention with meal replacement by formula diet, exercise stimulation, and telemedicine coaching.
Treatment:
Combination Product: Lifestyle intervention
Control group
No Intervention group
Description:
Routine care.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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