Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT05933759
Status:
COMPLETED
Last Update Posted:
2024-07-11
First Post:
2023-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weight Reduction With the Low-Insulin-Method
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-10', 'studyFirstSubmitDate': '2023-06-27', 'studyFirstSubmitQcDate': '2023-06-27', 'lastUpdatePostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'gut microbiome composition in percent', 'timeFrame': '12 weeks', 'description': 'difference between groups'}], 'primaryOutcomes': [{'measure': 'Weight change in kg', 'timeFrame': '12 weeks', 'description': 'Estimated treatment difference'}], 'secondaryOutcomes': [{'measure': 'body mass index in kg/m2', 'timeFrame': '12 weeks', 'description': 'Estimated treatment difference'}, {'measure': 'waist circumference in cm', 'timeFrame': '12 weeks', 'description': 'Estimated treatment difference'}, {'measure': 'hip circumference in cm', 'timeFrame': '12 weeks', 'description': 'Estimated treatment difference'}, {'measure': 'fat mass in kg', 'timeFrame': '12 weeks', 'description': 'Estimated treatment difference'}, {'measure': 'lean body mass in kg', 'timeFrame': '12 weeks', 'description': 'Estimated treatment difference'}, {'measure': 'muscle mass in kg', 'timeFrame': '12 weeks', 'description': 'Estimated treatment difference'}, {'measure': 'energy expenditure in kcal', 'timeFrame': '12 weeks', 'description': 'Estimated treatment difference'}, {'measure': 'blood pressure in mmHg', 'timeFrame': '12 weeks', 'description': 'Estimated treatment difference'}, {'measure': 'quality of life (short form questionnaire) in units on a scale', 'timeFrame': '12 weeks', 'description': 'Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome'}, {'measure': 'depression (German version of the Center for Epidemiological Studies-Depression Scale) in units on a scale', 'timeFrame': '12 weeks', 'description': 'Estimated treatment difference minimum 0, maximum 100 higher scores mean a worse outcome'}, {'measure': 'physical activity in min/day', 'timeFrame': '12 weeks', 'description': 'Estimated treatment difference'}, {'measure': 'physical activity in steps/day', 'timeFrame': '12 weeks', 'description': 'Estimated treatment difference'}, {'measure': 'eating behaviour (German version of the Three-factor Eating Questionnaire) in units on a scale', 'timeFrame': '12 weeks', 'description': 'Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome'}, {'measure': 'total cholesterol in mg/dl', 'timeFrame': '12 weeks', 'description': 'Estimated treatment difference'}, {'measure': 'HDL cholesterol in mg/dl', 'timeFrame': '12 weeks', 'description': 'Estimated treatment difference'}, {'measure': 'LDL cholesterol in mg/dl', 'timeFrame': '12 weeks', 'description': 'Estimated treatment difference'}, {'measure': 'triglycerides in mg/dl', 'timeFrame': '12 weeks', 'description': 'Estimated treatment difference'}, {'measure': 'fasting blood glucose in mg/dl', 'timeFrame': '12 weeks', 'description': 'Estimated treatment difference'}, {'measure': 'insulin in µU/ml', 'timeFrame': '12 weeks', 'description': 'Estimated treatment difference'}, {'measure': 'HbA1c in %', 'timeFrame': '12 weeks', 'description': 'Estimated treatment difference'}, {'measure': 'food frequency (German version of the food frequency questionnaire) in units on a scale', 'timeFrame': '12 weeks', 'description': 'Estimated treatment difference minimum 0, maximum 100 higher scores mean a better outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight and Obesity']}, 'descriptionModule': {'briefSummary': "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.\n\nMethod: 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.\n\nObjective: 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index 25 kg/m2\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT05933759', 'acronym': 'WeR-LIM', 'briefTitle': 'Weight Reduction With the Low-Insulin-Method', 'organization': {'class': 'OTHER', 'fullName': 'West German Center of Diabetes and Health'}, 'officialTitle': 'Weight Reduction With the Low-Insulin-Method in an Occupational Health Setting', 'orgStudyIdInfo': {'id': 'WeR-LIM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps, and telemedical coaching.', 'interventionNames': ['Behavioral: Telemedical coaching', 'Behavioral: Low-Insulin-Method']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps.', 'interventionNames': ['Behavioral: Low-Insulin-Method']}], 'interventions': [{'name': 'Telemedical coaching', 'type': 'BEHAVIORAL', 'description': 'Individual telemedical coaching delivered by a nutritional consultant', 'armGroupLabels': ['Intervention group']}, {'name': 'Low-Insulin-Method', 'type': 'BEHAVIORAL', 'description': 'Lifestyle intervention with education via the Low-Insulin-App, low-carb diet, self-monitoring of weight and steps', 'armGroupLabels': ['Control group', 'Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40591', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'West German Centre of Diabetes and Health', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West German Center of Diabetes and Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Bonn', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}