Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-23 @ 1:11 AM
Study NCT ID:
NCT03968458
Status:
COMPLETED
Last Update Posted:
2025-07-10
First Post:
2019-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Exercise Timing on Energy Intake and Appetite in Adolescents With Obesity: the TIMEX 3 Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-09', 'studyFirstSubmitDate': '2019-04-29', 'studyFirstSubmitQcDate': '2019-05-27', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of energy intake measured during an ad libitum buffet meal (in kcal).', 'timeFrame': 'day 1 , day 8, day 15', 'description': 'Change of food intake will be measured ad libitum during a lunch buffet. The adolescents will be offered an ad libitum buffet-type meal composed based on their food intake preferences. Their intake will be weighted using an electronic food scale by a member of the investigation team and then analysed using Bilnuts software.'}], 'secondaryOutcomes': [{'measure': 'Hunger feelings', 'timeFrame': 'day 1 , day 8, day 15', 'description': ': hunger area under the curve will be assessed using visual analogue scale through a the day'}, {'measure': 'Food reward', 'timeFrame': 'day 1 , day 8, day 15', 'description': 'The participants will be asked to complete a validated computer-based procedure to measure food reward (Leeds Food Preference Questionnaire; LFPQ)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['appetite control', 'obesity', 'Adolescents', 'exercise timing'], 'conditions': ['Pediatric Obesity']}, 'referencesModule': {'references': [{'pmid': '38376518', 'type': 'DERIVED', 'citation': 'Moore H, Pereira B, Fillon A, Miguet M, Masurier J, Beaulieu K, Finlayson G, Thivel D. The association between obesity severity and food reward in adolescents with obesity: a one-stage individual participant data meta-analysis. Eur J Nutr. 2024 Jun;63(4):1241-1255. doi: 10.1007/s00394-024-03348-4. Epub 2024 Feb 20.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to compare the effect of the timing (30 vs. 90 minutes) between a fixed exercise and the following test meal on energy intake, appetite feelings and food reward in adolescents with obesity.', 'detailedDescription': 'The present study will compare the nutritional response to the realisation of an acute exercise 90 minutes or 30 minutes before an ad libitum buffet meal in adolescents with obesity. 18 adolescents with obesity will be asked to randomly complete three experimental sessions: i) one control session (rest); ii) one session with an acute exercise realized 90 minutes before lunch; iii) one session with the same exercise performed 30 minutes before lunch. Their ad libitum energy intake will be assessed during lunch as well as at dinner time. Appetite feelings will be assessed at regular intervals and their food reward in response to the lunch will also be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI percentile \\> 97th percentile according to the french curves.\n* ages 12-16 years old\n* Signed consent form\n* being registered in the national social security system\n* no contraindication to physical activity\n\nExclusion Criteria:\n\n* Previous surgical interventions that is considered as non-compatible with the study.\n* Diabetes\n* weight loss during the last 6 months\n* cardiovascular disease or risks'}, 'identificationModule': {'nctId': 'NCT03968458', 'acronym': 'TIMEX 3', 'briefTitle': 'Effect of Exercise Timing on Energy Intake and Appetite in Adolescents With Obesity: the TIMEX 3 Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Effect of Exercise Timing on Energy Intake and Appetite in Adolescents With Obesity: the TIMEX 3 Study', 'orgStudyIdInfo': {'id': 'RBHP 2019 BOIRIE 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Obese adolescents', 'description': '18 adolescents with obesity are involved and will perform the three conditions.', 'interventionNames': ['Behavioral: CON', 'Behavioral: EX-30', 'Behavioral: EX-90']}], 'interventions': [{'name': 'CON', 'type': 'BEHAVIORAL', 'description': '. Control condition without exercise / rest condition. The adolescents will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at lunch and dinner times. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.', 'armGroupLabels': ['Obese adolescents']}, {'name': 'EX-30', 'type': 'BEHAVIORAL', 'description': 'Condition with an acute exercise set 30 minutes before lunch The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling), 30 minutes before lunch. Lunch will be served ad libitum as well as diner. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.', 'armGroupLabels': ['Obese adolescents']}, {'name': 'EX-90', 'type': 'BEHAVIORAL', 'description': 'condition with an acute exercise set 90 minutes before lunch. The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling), 30 minutes before lunch. Lunch will be served ad libitum as well as diner. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.', 'armGroupLabels': ['Obese adolescents']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'yves Boirie', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': "Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}