- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03007459
The Health of Competitive Fitness Athletes
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Recreational 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Oslo, Norway, 0806
- Norwegian School of Sports Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Female, fitness athletes are being recruited through social media, Fitness team leaders and the Norwegian national federation for Bodybuilding and Fitness.
Physically active, female controls are being recruited through social media, training facilities and through colleagues at the Norwegian School of Sport Sciences
Description
Inclusion Criteria:
- Fitness athletes: planning to compete in fitness sport during spring or fall 2017
- Controls: being regular physically active (exercise >2 times/week during last year) with a BMI between 17,5-30
Exclusion Criteria:
- Controls: having competed in fitness sports previously or planning to do in the future, or working as a personal trainer.
- Not able to meet at the Norwegian School of Sport Sciences for baseline and follow up screenings.
- Being pregnant or nursing
- Metabolic related diseases
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Female Fitness Athletes
Psychological health and physiological health of fitness athletes
|
Observing and measuring baseline, and changes in, psychological health through a fitness contest preparation period
Observing and measuring baseline, and changes in, physiological health through a fitness contest preparation period
|
|
Female, physically active Controls
Psychological health and physiological health of female controls
|
Observing and measuring baseline, and changes in, psychological health through a fitness contest preparation period
Observing and measuring baseline, and changes in, physiological health through a fitness contest preparation period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body composition
Time Frame: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
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)
|
Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resting Metabolic Rate
Time Frame: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
Baseline values, change from pre-test to mid-test, and finally change from mid- to posttest, for resting metabolic rate, measured with indirect calorimetry
|
Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
|
Bone Mineral Density
Time Frame: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
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)
|
Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
|
Perfectionism
Time Frame: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
Comparing scores on perfectionism between case and controls, and individual changes in scores through study period, with Child Adolescent Perfectionism Scale (CAPS 22 items)
|
Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
|
Depression
Time Frame: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
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)
|
Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
|
Eating disorders
Time Frame: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
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)
|
Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
|
Eating behavior; binge eating
Time Frame: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
Baseline values, change from pre-test to mid-test, and finally change from mid- to post-test, for scores on Binge Eating Scale (BES)
|
Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
|
Eating behavior; restrictive eating and sensation of hunger
Time Frame: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
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)
|
Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
|
Menstrual Status, self-reported
Time Frame: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
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)
|
Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
|
Dietary intake, weighed diet registration
Time Frame: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
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)
|
Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
|
Exercise dependency
Time Frame: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
Baseline status, change from pre-test to mid-test, and finally change from pre- to post-test, evaluated with Exercise Dependency Scale (EDS)
|
Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
|
Reason for Exercise
Time Frame: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
Baseline status, change from pre-test to mid-test, and finally change from pre- to post-test, evaluated with Reason for Exercise Inventory (REI)
|
Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
|
Depression
Time Frame: Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)
|
Changes in reported state of depression during the dieting period of fitness athletes, measured with BDI
|
Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)
|
|
Dietary intake, 24-hour recall interview
Time Frame: Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)
|
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)
|
Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)
|
|
Menstrual cycle, self reported
Time Frame: Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)
|
Self reported menstrual bleeding's during the dieting period of fitness athletes (LEAF)
|
Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)
|
|
Eating disordered behavior
Time Frame: Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)
|
Changes in eating behavior during the dieting period of fitness athletes, measured with the behavioral aspects of EDE-q
|
Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)
|
|
Eating behavior; binge eating behavior
Time Frame: Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)
|
Changes in eating behavior during the dieting period of fitness athletes, measured with BES
|
Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)
|
|
Eating behavior; restrictive eating and sensation of hunger
Time Frame: Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)
|
Changes in eating behavior during the dieting period of fitness athletes, measured with TFEQ-21
|
Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)
|
|
Training volume, self reported
Time Frame: Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)
|
Reporting number of training sessions pr week and type of exercise (endurance related exercise or strength training)
|
Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)
|
|
Training history, self reported
Time Frame: Retrospective
|
Reporting experience with training, giving details on specific sport activity and typical intensity
|
Retrospective
|
|
Dietary Supplements
Time Frame: 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)
|
Reporting usage of dietary supplements during the dieting period
|
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)
|
|
Eating disorders, history
Time Frame: Retrospective
|
Reporting previous eating disorder and whether treatment were recieved or not
|
Retrospective
|
|
Drive for Muscularity
Time Frame: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
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)
|
Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
|
Drive for Leanness
Time Frame: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
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)
|
Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
|
|
Body Weight, history
Time Frame: Retrospective
|
Reporting lowest and highest bodyweight after 18 yr's of age (excluding periods of pregnancy)
|
Retrospective
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Jorunn K Sundgot-Borgen, Professor, Professor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3281
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
Massachusetts General HospitalRecruitingDepression | Depression - Major Depressive Disorder | Depression Chronic | Depression in Adults | Depression Disorders | Depression DisorderUnited States
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)Active, not recruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
ProgenaBiomeWithdrawnDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Sorlandet Hospital HFUniversity of Oslo; Karolinska Institutet; Australian Catholic University; Helse...RecruitingAnxiety | Anxiety Depression | Depression Anxiety Disorder | Depression - Major Depressive DisorderNorway
-
Lipocine Inc.CompletedDepression, Postpartum | Postnatal Depression | Peripartum Depression | Depression, Post-Partum | Postpartum Depression (PPD) | Post-Natal DepressionUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryActive, not recruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Kolby Walker, DO; Brittany KimbleRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of CincinnatiNational Center for Complementary and Integrative Health (NCCIH)RecruitingMild DepressionUnited States
-
Fondation FondaMentalGYNOVNot yet recruitingDepression | Depression in Adults | Depression DisorderFrance
Clinical Trials on Psychological health
-
Universidad de GranadaOdense University Hospital; University of Southern DenmarkCompletedPregnancy Related | Intimate Partner Violence | Violence, Gender-BasedDenmark, Spain
-
University of MichiganSTEER for Student AthletesCompleted
-
University of GaziantepNot yet recruitingHPV - Anogenital Human Papilloma Virus Infection | Cancer , Healthy | Health Belief Model
-
Medical University of ViennaCompletedDepressive; Episode, Major | Recurrent Depressive Disorder, Current Episode Moderate | Recurrent Depressive Disorder, Current Episode MildAustria
-
Fort Belvoir Community HospitalThe Defense and Veterans Brain Injury CenterWithdrawnTraumatic Brain InjuryUnited States
-
Lancashire Care NHS Foundation TrustUniversity of ManchesterCompletedDepression, Postpartum | Postnatal Depression in British South Asian WomenUnited Kingdom
-
Shanxi Bethune HospitalCompletedNon-Small Cell Lung CancerChina
-
The University of Hong KongRecruitingEcological Momentary Assessment | mHealth Intervention | Postpartum Depression (PPD)Hong Kong
-
Galina VelikovaThe Leeds Teaching Hospitals NHS Trust; European Organisation for Research...CompletedQuality of Life | Cognitive Impairment | Health-related Quality of Life | Long-term Effects of Cancer Treatment | WHO Grade II Oligodendroglial Tumor | WHO Grade III Oligodendroglial TumorNetherlands, United Kingdom
-
Second Affiliated Hospital, School of Medicine,...CompletedAnxiety | SARS-CoV-2 Infection | Mental Health Issue | Staff AttitudeChina