Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-03 @ 6:02 PM
Study NCT ID:
NCT06627569
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-11
First Post:
2024-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Effects on the Neurobiology Underlying Stress-related Eating Behaviors in Veterans
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The investigator and outcomes assessors will not know the group assignment of participants.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be asked to complete 2 study days before and again after a 12-week intervention period, during which they will either continue with usual activities or be asked to complete exercise sessions four times per week. They will be randomly assigned to one of these conditions (exercise or not) and will not be able to choose their group assignment.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2024-10-03', 'studyFirstSubmitQcDate': '2024-10-03', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in percent body fat', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Change in percent body fat, as measured by dual-energy x-ray absorptiometry, from baseline to after the 12-week intervention period.'}, {'measure': 'Percent change in body weight', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Percent change in body weight (kg) from baseline to after the 12-week intervention period.'}], 'primaryOutcomes': [{'measure': 'Percent change in blood oxygen level dependent (BOLD) response to visual food cues as measured by functional magnetic resonance imaging (fMRI)', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Percent change in blood oxygen level dependent (BOLD) response from baseline to after the 12-week intervention period while viewing visual food cues. The primary contrast of interest is the comparison of high-calorie food images to nonfood object images.'}, {'measure': 'Change in serum cortisol response to counting task', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Change from baseline to after the 12-week intervention period in serum cortisol levels (mcg/dL) throughout a counting task involving mental math (measured as area under the curve).'}], 'secondaryOutcomes': [{'measure': 'Change in heart rate response to counting task', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Change from baseline to after the 12-week intervention period in heart rate (measured by photoplethysmograph; aggregated in 1 min intervals) throughout a counting task involving mental math (measured as area under the curve).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Overweight', 'Obesity', 'Stress', 'Eating'], 'conditions': ['Overweight/Obesity', 'Stress']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn more about how common lifestyle interventions, such as exercise, affect how our brains respond to performing thinking tasks and to viewing pictures of foods and various other objects. The investigators are also interested in how changes in hormones that might be different in men and women could affect how lifestyle interventions change these brain responses.', 'detailedDescription': 'The purpose of this study is to learn more about how common lifestyle interventions, such as exercise, affect how our brains respond to performing thinking tasks and to viewing pictures of foods and various other objects. The investigators are also interested in how changes in hormones that might be different in men and women could affect how lifestyle interventions change these brain responses. This will help us to better understand how different lifestyle interventions affect the brain and how this might relate to various behaviors. Eligible participants will be asked to complete 2 study days before and again after a 12-week intervention period, during which they will either continue with usual activities or be asked to complete exercise sessions four times per week. They will be randomly assigned to one of these conditions (exercise or not) and will not be able to choose their group assignment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Veterans 18-75 years old\n* BMI of 25 or greater\n* Physically inactive\n* Able to attend study visits in person in Aurora, CO\n\nExclusion Criteria:\n\n* Currently pregnant\n* History of bariatric surgery\n* Contraindication to MRI (weight \\> 500 lbs; claustrophobia; metal or electronic devices in the body)\n* Unable to exercise due to cardiac, pulmonary, neurologic, or orthopedic reasons\n* Unable to pass screening graded exercise treadmill test'}, 'identificationModule': {'nctId': 'NCT06627569', 'briefTitle': 'Exercise Effects on the Neurobiology Underlying Stress-related Eating Behaviors in Veterans', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Exercise Effects on the Neurobiology Underlying Stress-Related Eating Behaviors in Veterans', 'orgStudyIdInfo': {'id': 'ENDA-009-24S'}, 'secondaryIdInfos': [{'id': 'I01CX002752', 'link': 'https://reporter.nih.gov/quickSearch/I01CX002752', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': 'Participants will complete 4 aerobic exercise training sessions per week for 12 weeks. The exercise program will begin at 15 minutes per session and duration will be gradually increased by 5 minutes each week until you reach 45 minutes per session. Exercise will be performed at a "moderate to vigorous "intensity, which will be about 60-70% of your predicted maximal level. Participants will meet with study personnel once per week.', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Usual activity', 'description': 'Participants will keep doing what they usually do for the 12-week intervention period. They will be asked not to change their usual physical activity levels during this period. They will meet with study personnel once per week'}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': '12 weeks of aerobic exercise, with 4 sessions per week.', 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045-7211', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'contacts': [{'name': 'Kristina T Legget, PhD', 'role': 'CONTACT', 'email': 'kristina.legget@va.gov', 'phone': '720-724-5809'}, {'name': 'Jason R. Tregellas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kristina T. Legget, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rocky Mountain Regional VA Medical Center, Aurora, CO', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'centralContacts': [{'name': 'Kristina T Legget, PhD', 'role': 'CONTACT', 'email': 'kristina.legget@va.gov', 'phone': '(720) 724-5809'}], 'overallOfficials': [{'name': 'Jason R. Tregellas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rocky Mountain Regional VA Medical Center, Aurora, CO'}, {'name': 'Kristina T. Legget, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rocky Mountain Regional VA Medical Center, Aurora, CO'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will become available after publication of study results and be available at least 3 years beyond the completion of the study.', 'ipdSharing': 'YES', 'description': 'As some journals now require authors to provide access to data, de-identified, anonymized data sets will be created after study results are published, and made available upon request for general research purposes, based on availability of resources. No proprietary data will be made publicly available. Sufficient data and descriptors will be made available to confirm conclusions in resulting publications and duplicate statistical analyses.', 'accessCriteria': 'Data will be made available upon request for general research purposes, based on availability of resources.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}