Overweight and ObesityWeR-LIMNCT05933759
Weight Reduction With the Low-Insulin-Method
A study testing Telemedical coaching and Low-Insulin-Method 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 Low-Insulin-Method 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?
- Telemedical coaching and Low-Insulin-Method
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jul 2023to 30 Jun 2024
- 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
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Weight Reduction With the Low-Insulin-Method in an Occupational Health Setting
Background: Overweight and obesity affect health, quality of life and ability to work. Therefore, the Low-Insulin-Method was developed to support overweight and obese people in weight loss.
Method: In a randomized controlled clinical trial, the effect of the lifestyle intervention program 'Low-Insulin-Method', delivered by the Low-Insulin-App including low-carb diet, self monitoring of weight, physical activity and telemedical coaching is examined compared to a control group without coaching. The learning contents are taught in 30 videos and 5 online meetings. The intervention group additionally gets 4 individual care calls. The state of health is examined at the beginning and after 12 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
- Telemedical coaching, Low-Insulin-Method
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedical coachingBehavioural
Individual telemedical coaching delivered by a nutritional consultant
Low-Insulin-MethodBehavioural
Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps, and telemedical coaching. Receives: Behavioral: Telemedical coaching; Behavioral: Low-Insulin-Method |
| Control group | Active comparator | Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps. Receives: Behavioral: Low-Insulin-Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change in kg
Estimated treatment difference
Measured: 12 weeks
Secondary outcomes (21)
body mass index in kg/m2
Estimated treatment difference
Measured: 12 weeks
waist circumference in cm
Estimated treatment difference
Measured: 12 weeks
hip circumference in cm
Estimated treatment difference
Measured: 12 weeks
fat mass in kg
Estimated treatment difference
Measured: 12 weeks
lean body mass in kg
Estimated treatment difference
Measured: 12 weeks
muscle mass in kg
Estimated treatment difference
Measured: 12 weeks
energy expenditure in kcal
Estimated treatment difference
Measured: 12 weeks
blood pressure in mmHg
Estimated treatment difference
Measured: 12 weeks
quality of life (short form questionnaire) in units on a scale
Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome
Measured: 12 weeks
depression (German version of the Center for Epidemiological Studies-Depression Scale) in units on a scale
Estimated treatment difference minimum 0, maximum 100 higher scores mean a worse outcome
Measured: 12 weeks
physical activity in min/day
Estimated treatment difference
Measured: 12 weeks
physical activity in steps/day
Estimated treatment difference
Measured: 12 weeks
eating behaviour (German version of the Three-factor Eating Questionnaire) in units on a scale
Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome
Measured: 12 weeks
total cholesterol in mg/dl
Estimated treatment difference
Measured: 12 weeks
HDL cholesterol in mg/dl
Estimated treatment difference
Measured: 12 weeks
LDL cholesterol in mg/dl
Estimated treatment difference
Measured: 12 weeks
triglycerides in mg/dl
Estimated treatment difference
Measured: 12 weeks
fasting blood glucose in mg/dl
Estimated treatment difference
Measured: 12 weeks
insulin in µU/ml
Estimated treatment difference
Measured: 12 weeks
HbA1c in %
Estimated treatment difference
Measured: 12 weeks
food frequency (German version of the food frequency questionnaire) in units on a scale
Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start15 Jul 2023
- Primary completion31 Dec 2023
- Study completion30 Jun 2024
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- West German Center of Diabetes and Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bonn
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933759
- Sponsor's protocol ID
- WeR-LIM
- Acronym
- WeR-LIM
- Status last verified
- Jul 2024
- First submitted
- 27 Jun 2023
- Last updated
- 11 Jul 2024
- 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 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Reduction With the Low-Insulin-Method in an Occupational Health Setting
- ClinicalTrials.gov ID
- NCT05933759
- Acronym / sponsor ID
- WeR-LIM / WeR-LIM
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- West German Center of Diabetes and HealthUniversity, hospital or other
- Collaborators
- University of Bonn
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 6 Jul 2023 (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 Low-Insulin-Method was developed to support overweight and obese people in weight loss.
Method: In a randomized controlled clinical trial, the effect of the lifestyle intervention program 'Low-Insulin-Method', delivered by the Low-Insulin-App including low-carb diet, self monitoring of weight, physical activity and telemedical coaching is examined compared to a control group without coaching. The learning contents are taught in 30 videos and 5 online meetings. The intervention group additionally gets 4 individual care calls. The state of health is examined at the beginning and after 12 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Telemedical coaching, Behavioral: Low-Insulin-MethodLifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps, and telemedical coaching. |
| Control group | Active comparator | Behavioral: Low-Insulin-MethodLifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps. |
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 (1 listed)
- none
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 |
|---|---|---|
| Telemedical coachingIndividual telemedical coaching delivered by a nutritional consultant | Behavioural | Intervention group |
| Low-Insulin-MethodLifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps | Behavioural | Control group, Intervention group |
Primary outcome
Weight change in kg
Time frame: 12 weeks
Estimated treatment difference
21 secondary outcomes
body mass index in kg/m2
Time frame: 12 weeks
waist circumference in cm
Time frame: 12 weeks
hip circumference in cm
Time frame: 12 weeks
fat mass in kg
Time frame: 12 weeks
lean body mass in kg
Time frame: 12 weeks
muscle mass in kg
Time frame: 12 weeks
energy expenditure in kcal
Time frame: 12 weeks
blood pressure in mmHg
Time frame: 12 weeks
quality of life (short form questionnaire) in units on a scale
Time frame: 12 weeks
depression (German version of the Center for Epidemiological Studies-Depression Scale) in units on a scale
Time frame: 12 weeks
physical activity in min/day
Time frame: 12 weeks
physical activity in steps/day
Time frame: 12 weeks
eating behaviour (German version of the Three-factor Eating Questionnaire) in units on a scale
Time frame: 12 weeks
total cholesterol in mg/dl
Time frame: 12 weeks
HDL cholesterol in mg/dl
Time frame: 12 weeks
LDL cholesterol in mg/dl
Time frame: 12 weeks
triglycerides in mg/dl
Time frame: 12 weeks
fasting blood glucose in mg/dl
Time frame: 12 weeks
insulin in µU/ml
Time frame: 12 weeks
HbA1c in %
Time frame: 12 weeks
food frequency (German version of the food frequency questionnaire) in units on a scale
Time frame: 12 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 11 Jul 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedical coaching and Low-Insulin-Method 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 1 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 11 Jul 2024. 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 change in kg (time frame: 12 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 11 Jul 2024.