Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-02-10 @ 1:30 PM
Study NCT ID:
NCT01837134
Status:
COMPLETED
Last Update Posted:
2014-05-29
First Post:
2013-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telemedical Coaching for Weight Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], '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'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-28', 'studyFirstSubmitDate': '2013-04-15', 'studyFirstSubmitQcDate': '2013-04-17', 'lastUpdatePostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'eating behaviour', 'timeFrame': '12 weeks', 'description': 'Eating behaviour will be measured using the validated questionnaire FEV.'}], 'primaryOutcomes': [{'measure': 'weight loss', 'timeFrame': '12 weeks', 'description': 'Weight will be measured at baseline and after 12 weeks.'}], 'secondaryOutcomes': [{'measure': 'cardiometabolic risk factors', 'timeFrame': '12 weeks'}, {'measure': 'quality of life', 'timeFrame': '12 weeks', 'description': 'Quality of life will be assessed by the validated questionnaires ADS-L and SF-12.'}, {'measure': 'physical activity', 'timeFrame': '12 weeks', 'description': 'Physical activity will be assessed using a validated questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['telemedicine', 'overweight', 'obesity'], 'conditions': ['Overweight', 'Obesity', 'Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '30975666', 'type': 'DERIVED', 'citation': 'Kempf K, Rohling M, Martin S, Schneider M. Telemedical coaching for weight loss in overweight employees: a three-armed randomised controlled trial. BMJ Open. 2019 Apr 11;9(4):e022242. doi: 10.1136/bmjopen-2018-022242.'}]}, 'descriptionModule': {'briefSummary': 'Lifestyle changes often fail due to loss of motivation. Telemedicine and personal coaching have the potential to support lifestyle change and weight loss. Therefore, the aim of our randomized controlled trial is to examine the effect of telemedicine with and without coaching in comparison to a control group on weight loss in overweight participants.', 'detailedDescription': 'In an occupational health care setting employees with overweight and/or metabolic syndrome will be randomized into a three arm 12-week trial. Participants in the telemedical (TM) and telemedical coaching (TMC) group got a weighing machine and a step counter, with automatic transfer into a personalized online portal, which could be monitored from both, the participant and the study centre. The TMC group weekly will get care calls from the study centre aiming to discuss measured data and to fix target agreements. The control group will remain in routine care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* employed at Boehringer Ingelheim Pharma GmbH for at least 2 years\n* older than 40 years\n* overweight or obese or metabolic syndrome\n\nExclusion Criteria:\n\n* not willing to participate'}, 'identificationModule': {'nctId': 'NCT01837134', 'acronym': 'Fit', 'briefTitle': 'Telemedical Coaching for Weight Loss', 'organization': {'class': 'OTHER', 'fullName': 'West German Center of Diabetes and Health'}, 'officialTitle': 'TeleLifestyleCoaching Study - Telemedical Coaching for Weight Loss', 'orgStudyIdInfo': {'id': 'Telemedical coaching'}, 'secondaryIdInfos': [{'id': '98149', 'type': 'OTHER_GRANT', 'domain': 'Boehringer Ingelheim Pharma GmbH & Co.KG'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control (C) group', 'description': 'The control group will remain in routine care for 12 weeks. After 12 weeks they will also be given a weighing machine and a step counter, with automatic transfer into a personalized online portal, which can be monitored from both, the participant and the study centre. During the next 12 weeks they will get care calls from the study centre aiming to discuss measured data and to fix target agreements.'}, {'type': 'EXPERIMENTAL', 'label': 'telemedical (TM) group', 'description': 'Participants in the telemedical (TM) group will get a weighing machine and a step counter, with automatic transfer into a personalized online portal, which can be monitored from both, the participant and the study centre.', 'interventionNames': ['Device: telemedical (TM) group']}, {'type': 'EXPERIMENTAL', 'label': 'telemedical coaching (TMC) group', 'description': 'Participants in the telemedical coaching (TMC) group will get a weighing machine and a step counter, with automatic transfer into a personalized online portal, which can be monitored from both, the participant and the study centre. Additionally, they will be called once per week for 12 weeks from the study centre aiming to discuss measured data and to fix target agreements. After 12 weeks the care calls be be given once per month for further 9 months.', 'interventionNames': ['Device: telemedical (TM) group', 'Behavioral: telemedical coaching (TMC) group']}], 'interventions': [{'name': 'telemedical (TM) group', 'type': 'DEVICE', 'description': 'telemedical devices (weighing machine and step counter)', 'armGroupLabels': ['telemedical (TM) group', 'telemedical coaching (TMC) group']}, {'name': 'telemedical coaching (TMC) group', 'type': 'BEHAVIORAL', 'description': 'care calls once per week for 12 weeks', 'armGroupLabels': ['telemedical coaching (TMC) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40591', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'West-German Centre of Diabetes and Health', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Stephan Martin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West-German Centre of Diabetes and Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West German Center of Diabetes and Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the West German Center of Diabetes and Health', 'investigatorFullName': 'Stephan Martin', 'investigatorAffiliation': 'West German Center of Diabetes and Health'}}}}