Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-03-19 @ 1:48 AM
Study NCT ID:
NCT02877004
Status:
COMPLETED
Last Update Posted:
2019-09-13
First Post:
2016-08-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
LLLT for Reducing Waste Circumference and Weight
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nicotineresearch@mayo.edu', 'phone': '507-266-1944', 'title': 'Dr. Ivana Croghan', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected during LLLT treatment for each group (4 weeks for group A; 6 weeks for group B; 12 weeks for group C).', 'description': 'All Adverse Events that met criteria for being Serious Adverse Events were recorded and followed up; In addition, adverse events not meeting SAE criteria and considered to be potentially related to the LLLT were also documented.', 'eventGroups': [{'id': 'EG000', 'title': 'Laser for 4 Weeks', 'description': '3 Low-Level Laser Therapy Treatments Weekly\n\n3 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatment - at a frequency of 3 times per week for 4 weeks', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Laser for 6 Weeks', 'description': '2 Low-Level Laser Therapy Treatments Weekly\n\n2 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatments - at a frequency of 2 times per week for 6 weeks', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Laser for 12 Weeks', 'description': '1 Low-Level Laser Therapy Treatment Weekly\n\n1 Low-Level Laser Therapy Treatment Weekly: Receive 12 LLLT treatments - at a frequency of once per week for 12 weeks', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Pregnancy', 'notes': 'Pregnancy - not considered related to treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser for 4 Weeks', 'description': '3 Low-Level Laser Therapy Treatments Weekly\n\n3 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatment - at a frequency of 3 times per week for 4 weeks'}, {'id': 'OG001', 'title': 'Laser for 6 Weeks', 'description': '2 Low-Level Laser Therapy Treatments Weekly\n\n2 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatments - at a frequency of 2 times per week for 6 weeks'}, {'id': 'OG002', 'title': 'Laser for 12 Weeks', 'description': '1 Low-Level Laser Therapy Treatment Weekly\n\n1 Low-Level Laser Therapy Treatment Weekly: Receive 12 LLLT treatments - at a frequency of once per week for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '1.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.723', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Data were analyzed using analysis of covariance with the baseline value included as the covariate.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'description': 'Comparison of weight change from baseline between arms', 'unitOfMeasure': 'Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser for 4 Weeks', 'description': '3 Low-Level Laser Therapy Treatments Weekly\n\n3 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatment - at a frequency of 3 times per week for 4 weeks'}, {'id': 'OG001', 'title': 'Laser for 6 Weeks', 'description': '2 Low-Level Laser Therapy Treatments Weekly\n\n2 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatments - at a frequency of 2 times per week for 6 weeks'}, {'id': 'OG002', 'title': 'Laser for 12 Weeks', 'description': '1 Low-Level Laser Therapy Treatment Weekly\n\n1 Low-Level Laser Therapy Treatment Weekly: Receive 12 LLLT treatments - at a frequency of once per week for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '2.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.368', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Data were analyzed using analysis of covariance with the baseline value included as the covariate'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'description': 'Comparison of waist circumference change from baseline between arms', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Laser for 4 Weeks', 'description': '3 Low-Level Laser Therapy Treatments Weekly\n\n3 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatment - at a frequency of 3 times per week for 4 weeks'}, {'id': 'FG001', 'title': 'Laser for 6 Weeks', 'description': '2 Low-Level Laser Therapy Treatments Weekly\n\n2 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatments - at a frequency of 2 times per week for 6 weeks'}, {'id': 'FG002', 'title': 'Laser for 12 Weeks', 'description': '1 Low-Level Laser Therapy Treatment Weekly\n\n1 Low-Level Laser Therapy Treatment Weekly: Receive 12 LLLT treatments - at a frequency of once per week for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants recruited from the local community of Rochester, MN, 09/16-08/17. All interested individuals called a central number and underwent a 10-minute phone pre-screen. If they passed the telephone pre-screen, they were invited to attend an in-person consent visit. All study visits and treatments took place in Mayo Clinic - Rochester Campus.', 'preAssignmentDetails': 'After consent, patients were screened for study entry criteria. Only those who passed all criteria were invited to be randomized to study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Laser for 4 Weeks', 'description': '3 Low-Level Laser Therapy Treatments Weekly\n\n3 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatment - at a frequency of 3 times per week for 4 weeks'}, {'id': 'BG001', 'title': 'Laser for 6 Weeks', 'description': '2 Low-Level Laser Therapy Treatments Weekly\n\n2 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatments - at a frequency of 2 times per week for 6 weeks'}, {'id': 'BG002', 'title': 'Laser for 12 Weeks', 'description': '1 Low-Level Laser Therapy Treatment Weekly\n\n1 Low-Level Laser Therapy Treatment Weekly: Receive 12 LLLT treatments - at a frequency of once per week for 12 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.6', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '40.8', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '45.8', 'spread': '10.1', 'groupId': 'BG002'}, {'value': '43.7', 'spread': '9.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'White/Non Hispanic', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight (kg)', 'classes': [{'categories': [{'measurements': [{'value': '81.7', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '77.1', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '75.4', 'spread': '7.9', 'groupId': 'BG002'}, {'value': '78.1', 'spread': '8.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist Circumference (cm)', 'classes': [{'categories': [{'measurements': [{'value': '93.2', 'spread': '7.0', 'groupId': 'BG000'}, {'value': '91.4', 'spread': '7.2', 'groupId': 'BG001'}, {'value': '91.2', 'spread': '6.5', 'groupId': 'BG002'}, {'value': '91.9', 'spread': '6.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-28', 'size': 405436, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-08-12T14:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-09', 'studyFirstSubmitDate': '2016-08-17', 'resultsFirstSubmitDate': '2019-08-12', 'studyFirstSubmitQcDate': '2016-08-23', 'lastUpdatePostDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-09', 'studyFirstPostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Weight', 'timeFrame': 'baseline and 4 weeks', 'description': 'Comparison of weight change from baseline between arms'}, {'measure': 'Change in Waist Circumference', 'timeFrame': 'baseline and 4 weeks', 'description': 'Comparison of waist circumference change from baseline between arms'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Weight Loss']}, 'referencesModule': {'references': [{'pmid': '31473867', 'type': 'RESULT', 'citation': 'Croghan IT, Hurt RT, Schroeder DR, Fokken SC, Jensen MD, Clark MM, Ebbert JO. Low-level laser therapy for weight reduction: a randomized pilot study. Lasers Med Sci. 2020 Apr;35(3):663-675. doi: 10.1007/s10103-019-02867-5. Epub 2019 Aug 31.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to gather preliminary information on the effectiveness of Low Level Laser Therapy (LLLT) in helping people reduce their weight gain in the central body region.', 'detailedDescription': 'This will be an open label clinical trial with all study participants receiving LLLT. Preliminary data will be collected on the efficacy of LLLT based on varying frequency of treatments. The focus of this study on 60 overweight adults with a BMI of 25 to 29.9, and assess changes in weight and waist circumference at end of treatment for group 1 (week 4) and group 2 (week 6) and group 3 (week 12). Participants will be randomized to receive LLLT treatments either 3 times a week; 2 times a week; or once a week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. over 18 years of age;\n2. body weight of greater than 50 kg (110 pounds);\n3. BMI between 25-29.9 kg/m2;\n4. able to participate fully in all aspects of the study\n5. understood and signed study informed consent\n\nExclusion Criteria:\n\n1. used weight loss medications or participated in a weight loss program within past 30 days\n2. currently taking supplements known to affect weight (garcinia cambogia, etc.)\n3. weight fluctuations of 20 pounds or more in the past 6 months\n4. implanted device (including pacemaker or lap band) in the targeted area of LLLT\n5. known active eating disorder\n6. known, active, untreated clinically significant psychiatric condition (alcohol or substance abuse, psychosis, bipolar disorder, or depression)\n7. used an investigational drug within 30 days of study enrollment\n8. currently pregnant or lactating, or are of child-bearing potential or are likely to become pregnant during the medication phase and unwilling to use a reliable form of contraception\n9. history of any major cardiovascular events\n10. current uncontrolled hypertension\n11. clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, or metabolic disease\n12. Prior surgical intervention for body sculpting/weight loss\n13. medical, physical, or other contraindications for body sculpting/weight loss\n14. any medical condition known to affect weight levels or to cause bloating or swelling\n15. diagnosis of, and/or taking medication for, irritable bowel syndrome\n16. active infection, wound or other external trauma to the areas to be treated with the laser\n17. known photosensitivity disorder;\n18. current active cancer or currently receiving treatment for or within 1 year of cancer remission'}, 'identificationModule': {'nctId': 'NCT02877004', 'acronym': 'LLLT', 'briefTitle': 'LLLT for Reducing Waste Circumference and Weight', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Feasibility Study Addressing the Frequency of Low Level Laser Therapy for Reducing Central Adiposity and Weight in Overweight Individuals', 'orgStudyIdInfo': {'id': '16-004817'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Laser for 4 weeks', 'description': '3 Low-Level Laser Therapy Treatments Weekly', 'interventionNames': ['Device: 3 Low-Level Laser Therapy Treatments Weekly']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laser for 6 weeks', 'description': '2 Low-Level Laser Therapy Treatments Weekly', 'interventionNames': ['Device: 2 Low-Level Laser Therapy Treatments Weekly']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laser for 12 weeks', 'description': '1 Low-Level Laser Therapy Treatment Weekly', 'interventionNames': ['Device: 1 Low-Level Laser Therapy Treatment Weekly']}], 'interventions': [{'name': '3 Low-Level Laser Therapy Treatments Weekly', 'type': 'DEVICE', 'description': 'Receives 12 LLLT treatment - at a frequency of 3 times per week for 4 weeks', 'armGroupLabels': ['Laser for 4 weeks']}, {'name': '2 Low-Level Laser Therapy Treatments Weekly', 'type': 'DEVICE', 'description': 'Receives 12 LLLT treatments - at a frequency of 2 times per week for 6 weeks', 'armGroupLabels': ['Laser for 6 weeks']}, {'name': '1 Low-Level Laser Therapy Treatment Weekly', 'type': 'DEVICE', 'description': 'Receive 12 LLLT treatments - at a frequency of once per week for 12 weeks', 'armGroupLabels': ['Laser for 12 weeks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Ivana T Croghan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ivana Croghan', 'investigatorAffiliation': 'Mayo Clinic'}}}}