Overweight and ObesitySAMMASNCT03417674
SHAPE AND MOTION - Medical Accompanied Slimming
A study testing Lifestyle intervention in people with Overweight and Obesity, run by West German Center of Diabetes and Health at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Lifestyle intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 10 Feb 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index ≥ 25 kg/m2
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Overweight and Obesity
- Being tested
- Lifestyle intervention
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionCombination product
Meal replacement by formula diet, exercise stimulation, and telemedicine coaching.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Lifestyle intervention with meal replacement by formula diet, exercise stimulation, and telemedicine coaching. Receives: Combination Product: Lifestyle intervention |
| Control group | No intervention | Routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss in kg
Estimated treatment difference
Measured: 26 weeks
Secondary outcomes (23)
body mass index in kg/m2
Estimated treatment difference
Measured: 26 weeks
waist circumference in cm
Estimated treatment difference
Measured: 26 weeks
hip circumference in cm
Estimated treatment difference
Measured: 26 weeks
fat mass in kg
Estimated treatment difference
Measured: 26 weeks
lean body mass in kg
Estimated treatment difference
Measured: 26 weeks
muscle mass in kg
Estimated treatment difference
Measured: 26 weeks
energy expenditure in kcal
Estimated treatment difference
Measured: 26 weeks
blood pressure in mmHg
Estimated treatment difference
Measured: 26 weeks
quality of life (sf-12 questionnaire) in units on a scale
Estimated treatment difference
Measured: 26 weeks
depression (German version of the Center for Epidemiological Studies-Depression [CES-D] Scale) in units on a scale
Estimated treatment difference
Measured: 26 weeks
physical activity in min/day
Estimated treatment difference
Measured: 26 weeks
physical activity in steps/day
Estimated treatment difference
Measured: 26 weeks
eating behaviour (German version of the Three-factor Eating Questionnaire [TFEQ]) in units on a scale
Estimated treatment difference
Measured: 26 weeks
total cholesterol in mg/dl
Estimated treatment difference
Measured: 26 weeks
HDL cholesterol in mg/dl
Estimated treatment difference
Measured: 26 weeks
LDL cholesterol in mg/dl
Estimated treatment difference
Measured: 26 weeks
triglycerides in mg/dl
Estimated treatment difference
Measured: 26 weeks
fasting blood glucose in mg/dl
Estimated treatment difference
Measured: 26 weeks
insulin in µU/ml
Estimated treatment difference
Measured: 26 weeks
HbA1c in %
Estimated treatment difference
Measured: 26 weeks
uric acid in mg/dl
Estimated treatment difference
Measured: 26 weeks
creatinin in mg/dl
Estimated treatment difference
Measured: 26 weeks
medication in mg/day
Estimated treatment difference
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start10 Feb 2018
- Primary completion10 Apr 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- West German Center of Diabetes and Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan Martin, MD, Principal investigator, West-German Centre of Diabetes and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417674
- Sponsor's protocol ID
- FORM UND BEWEGUNG
- Acronym
- SAMMAS
- Status last verified
- Oct 2021
- First submitted
- 9 Jan 2018
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHAPE AND MOTION - Medical Accompanied Slimming
- ClinicalTrials.gov ID
- NCT03417674
- Acronym / sponsor ID
- SAMMAS / FORM UND BEWEGUNG
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- West German Center of Diabetes and HealthUniversity, hospital or other
- Study start
- 10 Feb 2018 (actual)
- Primary completion
- 10 Apr 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Combination Product: Lifestyle interventionLifestyle intervention with meal replacement by formula diet, exercise stimulation, and telemedicine coaching. |
| Control group | No intervention | –Routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body mass index ≥ 25 kg/m2
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle interventionMeal replacement by formula diet, exercise stimulation, and telemedicine coaching. | Combination product | Intervention group |
Primary outcome
Weight loss in kg
Time frame: 26 weeks
Estimated treatment difference
23 secondary outcomes
body mass index in kg/m2
Time frame: 26 weeks
waist circumference in cm
Time frame: 26 weeks
hip circumference in cm
Time frame: 26 weeks
fat mass in kg
Time frame: 26 weeks
lean body mass in kg
Time frame: 26 weeks
muscle mass in kg
Time frame: 26 weeks
energy expenditure in kcal
Time frame: 26 weeks
blood pressure in mmHg
Time frame: 26 weeks
quality of life (sf-12 questionnaire) in units on a scale
Time frame: 26 weeks
depression (German version of the Center for Epidemiological Studies-Depression [CES-D] Scale) in units on a scale
Time frame: 26 weeks
physical activity in min/day
Time frame: 26 weeks
physical activity in steps/day
Time frame: 26 weeks
eating behaviour (German version of the Three-factor Eating Questionnaire [TFEQ]) in units on a scale
Time frame: 26 weeks
total cholesterol in mg/dl
Time frame: 26 weeks
HDL cholesterol in mg/dl
Time frame: 26 weeks
LDL cholesterol in mg/dl
Time frame: 26 weeks
triglycerides in mg/dl
Time frame: 26 weeks
fasting blood glucose in mg/dl
Time frame: 26 weeks
insulin in µU/ml
Time frame: 26 weeks
HbA1c in %
Time frame: 26 weeks
uric acid in mg/dl
Time frame: 26 weeks
creatinin in mg/dl
Time frame: 26 weeks
medication in mg/day
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Martin, MD principal investigator
West-German Centre of Diabetes and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention in people with Overweight and Obesity, run by West German Center of Diabetes and Health at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss in kg (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.