Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT04073394
Status:
COMPLETED
Last Update Posted:
2023-02-03
First Post:
2019-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individualized Lifestyle Intervention for Obesity Management Based on Obesity Phenotypes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-02', 'studyFirstSubmitDate': '2019-08-28', 'studyFirstSubmitQcDate': '2019-08-28', 'lastUpdatePostDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '12-week total body weight loss', 'timeFrame': '12 weeks', 'description': 'Change in body weight during the 12 week study'}], 'secondaryOutcomes': [{'measure': 'Responder Rate', 'timeFrame': '12 weeks', 'description': 'Proportion of patients losing \\> 3% of total body weight'}, {'measure': 'Waist Circumference', 'timeFrame': '12 weeks', 'description': 'Change in waist circumference (cm)'}, {'measure': 'Fat Loss', 'timeFrame': '12 weeks', 'description': 'Change in fat mass during the 12 week study using DEXA'}, {'measure': 'Calorie Intake', 'timeFrame': '12 weeks', 'description': 'Change in daily calorie intake'}, {'measure': 'Calories to Fullness', 'timeFrame': '12 weeks', 'description': 'Change in calories consumed to fullness during the 12 week study using satiation test'}, {'measure': 'Gastric Emptying', 'timeFrame': '12 weeks', 'description': 'Change in half gastric emptying time during the 12 week study using scintigraphy'}, {'measure': 'Gastric Emptying 2 Hours', 'timeFrame': '12 weeks', 'description': 'Change in gastric emptying percentage at 2 hours during the 12 week study using scintigraphy'}, {'measure': 'Anxiety Level', 'timeFrame': '12 weeks', 'description': 'Change is anxiety level during the 12 week study using the HADS-A scale'}, {'measure': 'Emotional Eating', 'timeFrame': '12 weeks', 'description': 'Change is emotional eating level during the 12 week study using the TFEQ score'}, {'measure': 'Resting Metabolic Rate', 'timeFrame': '12 weeks', 'description': 'Change in resting energy expenditure during the 12 week study using an indirect calorimetry'}, {'measure': 'Adherence', 'timeFrame': '12 weeks', 'description': 'Adherence and compliance with program defined by the number of contacts with the team'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '37007741', 'type': 'DERIVED', 'citation': 'Cifuentes L, Ghusn W, Feris F, Campos A, Sacoto D, De la Rosa A, McRae A, Rieck T, Mansfield S, Ewoldt J, Friend J, Grothe K, Lennon RJ, Hurtado MD, Clark MM, Camilleri M, Hensrud DD, Acosta A. Phenotype tailored lifestyle intervention on weight loss and cardiometabolic risk factors in adults with obesity: a single-centre, non-randomised, proof-of-concept study. EClinicalMedicine. 2023 Mar 24;58:101923. doi: 10.1016/j.eclinm.2023.101923. eCollection 2023 Apr.'}], 'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this protocol is to define an "individualized diet" approach based on obesity related phenotypes (pathophysiology obesity classification), which would increase weight loss, adherence, and weight loss maintenance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with obesity (BMI \\>30Kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and uncontrolled life-threatening comorbidities (i.e. unstable angina).\n* Age: 18-65 years.\n* Gender: Men or women.\n\nExclusion Criteria:\n\n* Weight change greater than 3% in the previous 3 months (weight stable).\n* History of bariatric surgery including lap band and bariatric endoscopy.\n* Significant untreated psychiatric dysfunction including binge eating disorders and bulimia.\n* Current use of anti-obesity pharmacotherapy, medications known to affect weight (e.g., corticosteroids) or GLP-1 agonist/analog for T2DM\n* A positive score on the AUDIT-C questionnaire as judged by an investigator.\n* Patient has a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder study adherence'}, 'identificationModule': {'nctId': 'NCT04073394', 'briefTitle': 'Individualized Lifestyle Intervention for Obesity Management Based on Obesity Phenotypes', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': '"Mayo Clinic Diet" Individualized Lifestyle Intervention for Obesity Management Based on Obesity Phenotypes (PHENO-Diet Trial)', 'orgStudyIdInfo': {'id': '19-007485'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Lifestyle Intervention', 'description': 'Participants in this group will be instructed to follow a standard low calorie diet, recommended to have 30 minutes of physical activity 3-5 days per week, and will be followed by a wellness couch weekly.', 'interventionNames': ['Behavioral: Standard Lifestyle Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Modified Lifestyle Intervention', 'description': 'Participants in this group will have a tailored diet, exercise, and behavioral plan according to their obesity phenotype.', 'interventionNames': ['Behavioral: Modified Lifestyle Intervention']}], 'interventions': [{'name': 'Standard Lifestyle Intervention', 'type': 'BEHAVIORAL', 'description': 'Research team will prescribe diet, exercise, behavioral plan for the participant to follow for the 12 week study. The lifestyle plan will be based on the Mayo Clinic Diet program.', 'armGroupLabels': ['Standard Lifestyle Intervention']}, {'name': 'Modified Lifestyle Intervention', 'type': 'BEHAVIORAL', 'description': 'Research team will prescribe diet, exercise, behavioral plan for the participant to follow for the 12 week study. The lifestyle plan will be based on the participants obesity phenotype.', 'armGroupLabels': ['Modified Lifestyle Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Andres Acosta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Andres J. Acosta, M.D., Ph.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}