The Health of Competitive Fitness Athletes

March 28, 2018 updated by: Professor Jorunn Sundgot-Borgen, Norwegian School of Sport Sciences

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0806
        • Norwegian School of Sports Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Female Fitness Athletes
Psychological health and physiological health of fitness athletes
Other: Psychological health
Observing and measuring baseline, and changes in, psychological health through a fitness contest preparation period
Other: Physiological health
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
Other: Psychological health
Observing and measuring baseline, and changes in, psychological health through a fitness contest preparation period
Other: Physiological health
Observing and measuring baseline, and changes in, physiological health through a fitness contest preparation period

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Norwegian School of Sport Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Dairy Council

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jorunn K Sundgot-Borgen, Professor, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 24, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3281

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data are not planned to be available to other than the research group.

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.

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