Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-03-11 @ 9:22 PM
Study NCT ID:
NCT03007459
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2016-12-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Health of Competitive Fitness Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D002032', 'term': 'Bulimia'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D006963', 'term': 'Hyperphagia'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008603', 'term': 'Mental Health'}], 'ancestors': [{'id': 'D006262', 'term': 'Health'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-28', 'studyFirstSubmitDate': '2016-12-24', 'studyFirstSubmitQcDate': '2016-12-29', 'lastUpdatePostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body composition', 'timeFrame': 'Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)', 'description': 'Baseline values, change from pre-test to mid-test, and finally change from mid- to post-test, for lean body mass and fat mass, measured with Dual Xray absorptiometry (DXA)'}], 'secondaryOutcomes': [{'measure': 'Resting Metabolic Rate', 'timeFrame': 'Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)', 'description': 'Baseline values, change from pre-test to mid-test, and finally change from mid- to posttest, for resting metabolic rate, measured with indirect calorimetry'}, {'measure': 'Bone Mineral Density', 'timeFrame': 'Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)', 'description': 'Baseline values, change from pre-test to mid-test, and finally change from mid- to post-test, for bone mineral density measured with Dual Xray absorptiometry (DXA)'}, {'measure': 'Perfectionism', 'timeFrame': 'Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)', 'description': 'Comparing scores on perfectionism between case and controls, and individual changes in scores through study period, with Child Adolescent Perfectionism Scale (CAPS 22 items)'}, {'measure': 'Depression', 'timeFrame': 'Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)', 'description': 'Baseline values, change from pre-test to mid-test, and finally change from mid- to post-test, for scores on depressive mood, measured with Becks Depression Inventory (BDI)'}, {'measure': 'Eating disorders', 'timeFrame': 'Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)', 'description': 'Baseline values, change from pre-test to mid-test, and finally change from mid- to post-test, for scores on Eating disorder examination questionnaire (EDE-q)'}, {'measure': 'Eating behavior; binge eating', 'timeFrame': 'Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)', 'description': 'Baseline values, change from pre-test to mid-test, and finally change from mid- to post-test, for scores on Binge Eating Scale (BES)'}, {'measure': 'Eating behavior; restrictive eating and sensation of hunger', 'timeFrame': 'Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)', 'description': 'Baseline values, change from pre-test to mid-test, and finally change from mid- to post-test, for scores on Three Factor Eating Questionnaire (TFEQ-21)'}, {'measure': 'Menstrual Status, self-reported', 'timeFrame': 'Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)', 'description': 'Baseline status, change from pre-test to mid-test, and finally change from mid- to post-test, for self-reported menstruation health (Low Energy Availability in Females questionnaire, LEAF)'}, {'measure': 'Dietary intake, weighed diet registration', 'timeFrame': 'Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)', 'description': 'Change in dietary intake. Baseline status, change from pre-test to mid-test, and finally change from pre- to post-test, evaluated with weighed dietary registration and analysed with national analytical software (Kostholdsplanleggeren.no)'}, {'measure': 'Exercise dependency', 'timeFrame': 'Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)', 'description': 'Baseline status, change from pre-test to mid-test, and finally change from pre- to post-test, evaluated with Exercise Dependency Scale (EDS)'}, {'measure': 'Reason for Exercise', 'timeFrame': 'Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)', 'description': 'Baseline status, change from pre-test to mid-test, and finally change from pre- to post-test, evaluated with Reason for Exercise Inventory (REI)'}, {'measure': 'Depression', 'timeFrame': 'Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)', 'description': 'Changes in reported state of depression during the dieting period of fitness athletes, measured with BDI'}, {'measure': 'Dietary intake, 24-hour recall interview', 'timeFrame': 'Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)', 'description': 'Changes in energy and nutrient intake during the dieting period of fitness athletes, measured with dietary 24-hour recall interview and analysed with national analytical software (Kostholdsplanleggeren.no)'}, {'measure': 'Menstrual cycle, self reported', 'timeFrame': 'Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)', 'description': "Self reported menstrual bleeding's during the dieting period of fitness athletes (LEAF)"}, {'measure': 'Eating disordered behavior', 'timeFrame': 'Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)', 'description': 'Changes in eating behavior during the dieting period of fitness athletes, measured with the behavioral aspects of EDE-q'}, {'measure': 'Eating behavior; binge eating behavior', 'timeFrame': 'Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)', 'description': 'Changes in eating behavior during the dieting period of fitness athletes, measured with BES'}, {'measure': 'Eating behavior; restrictive eating and sensation of hunger', 'timeFrame': 'Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)', 'description': 'Changes in eating behavior during the dieting period of fitness athletes, measured with TFEQ-21'}, {'measure': 'Training volume, self reported', 'timeFrame': 'Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)', 'description': 'Reporting number of training sessions pr week and type of exercise (endurance related exercise or strength training)'}, {'measure': 'Training history, self reported', 'timeFrame': 'Retrospective', 'description': 'Reporting experience with training, giving details on specific sport activity and typical intensity'}, {'measure': 'Dietary Supplements', 'timeFrame': 'Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest), and each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)', 'description': 'Reporting usage of dietary supplements during the dieting period'}, {'measure': 'Eating disorders, history', 'timeFrame': 'Retrospective', 'description': 'Reporting previous eating disorder and whether treatment were recieved or not'}, {'measure': 'Drive for Muscularity', 'timeFrame': 'Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)', 'description': 'Baseline status, change from pre-test to mid-test, and finally change from pre- to post-test, evaluated with Drive for Muscularity (DM) (McCreary \\& Sasse 2000)'}, {'measure': 'Drive for Leanness', 'timeFrame': 'Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)', 'description': 'Baseline status, change from pre-test to mid-test, and finally change from pre- to post-test, evaluated with Drive for Leanness (DL) (Smolak \\& Murnen 2008)'}, {'measure': 'Body Weight, history', 'timeFrame': 'Retrospective', 'description': "Reporting lowest and highest bodyweight after 18 yr's of age (excluding periods of pregnancy)"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Body composition', 'Bone mineral density', 'Binge Eating', 'Eating Disorder', 'Exercise Dependency', 'Depression', 'Perfectionism', 'Body building', 'Drive for Muscularity', 'Drive for leanness'], 'conditions': ['Resting Metabolic Rate', 'Bone Mineral Density, Low, Susceptibility to', 'Body Image', 'Perfectionism', 'Depression', 'Eating Disorder', 'Exercise-Related Amenorrhea', 'Exercise Addiction', 'Binge Eating', 'Dietary Amenorrhea', 'Dietary Deficiency']}, 'referencesModule': {'references': [{'pmid': '29415831', 'type': 'DERIVED', 'citation': 'Mathisen TF, Engen KM, Sundgot-Borgen J, Stensrud T. Evaluation of a short protocol for indirect calorimetry in females with eating disorders and healthy controls. Clin Nutr ESPEN. 2017 Dec;22:28-35. doi: 10.1016/j.clnesp.2017.09.003. Epub 2017 Oct 5.'}]}, 'descriptionModule': {'briefSummary': 'Fitness athletes emphasize the value of staying lean, muscular and defined, and motivates and inspires followers through social media. We want to study the effect of such lifestyle on selected aspects of psychological and physical health in female fitness athletes, and compare the outcomes to a healthy, physically active female population.', 'detailedDescription': 'Little is known about the mental and physical health effect from following the modern, idealized fitness lifestyle. The lifestyle is characterized by selective and restrictive eating behavior, strength training and use of supplements. The athletes emphasize the value of staying lean, muscular and defined, and motivates and inspires followers through social media. This study will recruit and observe a group of competitive female fitness athletes over their typical 3 month dieting period when preparing for contest. Before their contest diet is initiated, the athletes will be screened on selected aspects of psychological and physical health. The screening is repeated two weeks prior to their first seasonal contest, and then finally one month post-contest season. During the diet period of 3 months, the athletes answers brief questionnaires by email on eating- and training behavior and on mood, while also reporting dietary intake by telephone interview.\n\nRecreational physically females, not planning to do any fitness contest, will be recruited to serve as a parallel control group. They will perform the same physical and psychological screening, and answer the same questionnaires throughout the fitness contest diet period.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female, fitness athletes are being recruited through social media, Fitness team leaders and the Norwegian national federation for Bodybuilding and Fitness.\n\nPhysically active, female controls are being recruited through social media, training facilities and through colleagues at the Norwegian School of Sport Sciences', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fitness athletes: planning to compete in fitness sport during spring or fall 2017\n* Controls: being regular physically active (exercise \\>2 times/week during last year) with a BMI between 17,5-30\n\nExclusion Criteria:\n\n* Controls: having competed in fitness sports previously or planning to do in the future, or working as a personal trainer.\n* Not able to meet at the Norwegian School of Sport Sciences for baseline and follow up screenings.\n* Being pregnant or nursing\n* Metabolic related diseases'}, 'identificationModule': {'nctId': 'NCT03007459', 'briefTitle': 'The Health of Competitive Fitness Athletes', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian School of Sport Sciences'}, 'officialTitle': "The Health of Competitive Fitness Athletes, a Cohort Study of Female Fitness Athletes and Physical Active Control's During and After Three Months of Fitness Contest Dieting", 'orgStudyIdInfo': {'id': '3281'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Female Fitness Athletes', 'description': 'Psychological health and physiological health of fitness athletes', 'interventionNames': ['Other: Psychological health', 'Other: Physiological health']}, {'label': 'Female, physically active Controls', 'description': 'Psychological health and physiological health of female controls', 'interventionNames': ['Other: Psychological health', 'Other: Physiological health']}], 'interventions': [{'name': 'Psychological health', 'type': 'OTHER', 'description': 'Observing and measuring baseline, and changes in, psychological health through a fitness contest preparation period', 'armGroupLabels': ['Female Fitness Athletes', 'Female, physically active Controls']}, {'name': 'Physiological health', 'type': 'OTHER', 'description': 'Observing and measuring baseline, and changes in, physiological health through a fitness contest preparation period', 'armGroupLabels': ['Female Fitness Athletes', 'Female, physically active Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0806', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Norwegian School of Sports Sciences', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Jorunn K Sundgot-Borgen, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data are not planned to be available to other than the research group.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian School of Sport Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Dairy Council', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Professor Jorunn Sundgot-Borgen', 'investigatorAffiliation': 'Norwegian School of Sport Sciences'}}}}