SHAPE AND MOTION - Medical Accompanied Slimming
SAMMAS
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2018
CompletedFirst Posted
Study publicly available on registry
January 31, 2018
CompletedStudy Start
First participant enrolled
February 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedOctober 12, 2021
October 1, 2021
1.2 years
January 9, 2018
October 11, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Weight loss in kg
Estimated treatment difference
26 weeks
Secondary Outcomes (23)
body mass index in kg/m2
26 weeks
waist circumference in cm
26 weeks
hip circumference in cm
26 weeks
fat mass in kg
26 weeks
lean body mass in kg
26 weeks
- +18 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALLifestyle intervention with meal replacement by formula diet, exercise stimulation, and telemedicine coaching.
Control group
NO INTERVENTIONRoutine care.
Interventions
Meal replacement by formula diet, exercise stimulation, and telemedicine coaching.
Eligibility Criteria
You may qualify if:
- Body mass index ≥ 25 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West-German Centre of Diabetes and Health
Düsseldorf, 40591, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephan Martin, MD
West-German Centre of Diabetes and Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2018
First Posted
January 31, 2018
Study Start
February 10, 2018
Primary Completion
April 10, 2019
Study Completion
December 31, 2020
Last Updated
October 12, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share