Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-29 @ 1:38 PM
Study NCT ID:
NCT04437550
Status:
COMPLETED
Last Update Posted:
2020-06-18
First Post:
2020-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Exercise Intensity on Energy Intake, Appetite and Enjoyment in Overweight and Obese Females
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': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-16', 'studyFirstSubmitDate': '2020-06-15', 'studyFirstSubmitQcDate': '2020-06-16', 'lastUpdatePostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in energy expenditure', 'timeFrame': 'immediately pre-breakfast, immediately pre-exercise, during exercise, and immediately post-exercise.', 'description': 'caloric expenditure measured via indirect calorimetry'}, {'measure': 'Change in energy intake', 'timeFrame': 'immediately post exercise', 'description': 'measured via standardized lunch'}, {'measure': 'Change in appetite', 'timeFrame': 'immediately pre-breakfast, immediately post-breakfast, immediately post-exercise and immediately pre-lunch', 'description': 'measured via circulating hormones leptin and acylated ghrelin'}, {'measure': 'Change in subjective hunger', 'timeFrame': 'baseline, immediately pre-exercise, immediately post-exercise, immediately pre-lunch, and immediately post-lunch', 'description': 'via visual analogue scale 100 mm, higher scores indicate greater hunger'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight and Obesity']}, 'descriptionModule': {'briefSummary': 'Interval exercise involves short bouts of high intensity exercise interspersed with periods of lower intensity exercise. The benefit is that a shorter total duration of exercise may be required to achieve cardiovascular benefits similar to or even superior to traditional longer bouts of steady state endurance exercise. However how this type of exercise affects appetite and energy intake, particularly in overweight and obese females is not well known.\n\nThis study involves two trials of exercise, one at high intensity and one at low intensity, followed by a buffet lunch, in overweight and obese females.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female\n2. Adult\n3. apparently healthy\n4. overweight or class I obese\n5. eumenorrheic\n\nExclusion Criteria:\n\n1. Diabetes\n2. pregnancy\n3. cardiovascular disease\n4. greater than 1 hour of structured physical activity per week\n5. thyroid disease\n6. polycystic ovary disease'}, 'identificationModule': {'nctId': 'NCT04437550', 'briefTitle': 'Effects of Exercise Intensity on Energy Intake, Appetite and Enjoyment in Overweight and Obese Females', 'organization': {'class': 'OTHER', 'fullName': 'Ohio University'}, 'officialTitle': 'Effects of Exercise Intensity on Energy Intake, Appetite and Enjoyment in Overweight and Obese Females', 'orgStudyIdInfo': {'id': '801776'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high-intensity', 'interventionNames': ['Other: Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'low-intensity', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'high intensity exercise = 15 x 60 s sprints at 85% velocity of VO2max (vVO2max) with 60 s walking at 20% vVO2max or moderate intensity exercise = walking at 60% vVO2max', 'armGroupLabels': ['high-intensity', 'low-intensity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18509', 'city': 'Scranton', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Human Physiology Lab', 'geoPoint': {'lat': 41.40916, 'lon': -75.6649}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Marywood University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Angela Hillman', 'investigatorAffiliation': 'Marywood University'}}}}