Resting Metabolic RateNCT03007459
The Health of Competitive Fitness Athletes
An observational study of Resting Metabolic Rate and Bone Mineral Density, Low, Susceptibility to, run by Norwegian School of Sport Sciences at 1 site in Norway.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Resting Metabolic Rate, Bone Mineral Density, Low, Susceptibility to, Body Image
- What is being tested?
- Psychological health and Physiological health
- How many people
- 47 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2016to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Resting Metabolic Rate, Bone Mineral Density, Low, Susceptibility to, Body Image, Perfectionism, Depression, Eating Disorder
- Being tested
- Psychological health, Physiological health
- Keywords
- Body composition, Bone mineral density, Binge Eating, Eating Disorder, Exercise Dependency, Depression, Perfectionism, Body building, Drive for Muscularity, Drive for leanness
- Medical subject headings
- Depression, Feeding and Eating Disorders, Bulimia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological healthOther
Observing and measuring baseline, and changes in, psychological health through a fitness contest preparation period
Physiological healthOther
Observing and measuring baseline, and changes in, physiological health through a fitness contest preparation period
| Study group | Role | What they receive |
|---|---|---|
| Female Fitness Athletes | Psychological health and physiological health of fitness athletes Receives: Other: Psychological health; Other: Physiological health | |
| Female, physically active Controls | Psychological health and physiological health of female controls Receives: Other: Psychological health; Other: Physiological health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
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)
Measured: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Secondary outcomes (24)
Resting Metabolic Rate
Baseline values, change from pre-test to mid-test, and finally change from mid- to posttest, for resting metabolic rate, measured with indirect calorimetry
Measured: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Bone Mineral Density
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)
Measured: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Perfectionism
Comparing scores on perfectionism between case and controls, and individual changes in scores through study period, with Child Adolescent Perfectionism Scale (CAPS 22 items)
Measured: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Depression
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)
Measured: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Eating disorders
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)
Measured: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Eating behavior; binge eating
Baseline values, change from pre-test to mid-test, and finally change from mid- to post-test, for scores on Binge Eating Scale (BES)
Measured: 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
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)
Measured: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Menstrual Status, self-reported
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)
Measured: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Dietary intake, weighed diet registration
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)
Measured: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Exercise dependency
Baseline status, change from pre-test to mid-test, and finally change from pre- to post-test, evaluated with Exercise Dependency Scale (EDS)
Measured: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Reason for Exercise
Baseline status, change from pre-test to mid-test, and finally change from pre- to post-test, evaluated with Reason for Exercise Inventory (REI)
Measured: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Depression
Changes in reported state of depression during the dieting period of fitness athletes, measured with BDI
Measured: Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)
Dietary intake, 24-hour recall interview
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)
Measured: Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)
Menstrual cycle, self reported
Self reported menstrual bleeding's during the dieting period of fitness athletes (LEAF)
Measured: Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)
Eating disordered behavior
Changes in eating behavior during the dieting period of fitness athletes, measured with the behavioral aspects of EDE-q
Measured: Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)
Eating behavior; binge eating behavior
Changes in eating behavior during the dieting period of fitness athletes, measured with BES
Measured: Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)
Eating behavior; restrictive eating and sensation of hunger
Changes in eating behavior during the dieting period of fitness athletes, measured with TFEQ-21
Measured: Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)
Training volume, self reported
Reporting number of training sessions pr week and type of exercise (endurance related exercise or strength training)
Measured: Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)
Training history, self reported
Reporting experience with training, giving details on specific sport activity and typical intensity
Measured: Retrospective
Dietary Supplements
Reporting usage of dietary supplements during the dieting period
Measured: 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
Reporting previous eating disorder and whether treatment were recieved or not
Measured: Retrospective
Drive for Muscularity
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)
Measured: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Drive for Leanness
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)
Measured: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Body Weight, history
Reporting lowest and highest bodyweight after 18 yr's of age (excluding periods of pregnancy)
Measured: Retrospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionNov 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Resting Metabolic RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian School of Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Dairy Council
- Responsible party
- Principal investigator, Professor Jorunn Sundgot-Borgen, Norwegian School of Sport Sciences
- Investigators
- Jorunn K Sundgot-Borgen, Professor, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007459
- Sponsor's protocol ID
- 3281
- Status last verified
- Mar 2018
- First submitted
- 24 Dec 2016
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data are not planned to be available to other than the research group.
Publications
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.
PubMed 29415831
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03007459
- Acronym / sponsor ID
- 3281
- Conditions
- Resting Metabolic Rate, Bone Mineral Density, Low, Susceptibility to, Body Image, Perfectionism, Depression, Eating Disorder
- Keywords
- Body composition, Bone mineral density, Binge Eating, Eating Disorder, Exercise Dependency, Depression, Perfectionism, Body building
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Norwegian School of Sport SciencesUniversity, hospital or other
- Collaborators
- National Dairy Council
- Study start
- Nov 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Female Fitness Athletes | – | Other: Psychological health, Other: Physiological healthPsychological health and physiological health of fitness athletes |
| Female, physically active Controls | – | Other: Psychological health, Other: Physiological healthPsychological health and physiological health of female controls |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological healthObserving and measuring baseline, and changes in, psychological health through a fitness contest preparation period | Other | Female Fitness Athletes, Female, physically active Controls |
| Physiological healthObserving and measuring baseline, and changes in, physiological health through a fitness contest preparation period | Other | Female Fitness Athletes, Female, physically active Controls |
Primary outcome
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)
24 secondary outcomes
Resting Metabolic Rate
Time frame: 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)
Perfectionism
Time frame: 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)
Eating disorders
Time frame: 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)
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)
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)
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)
Exercise dependency
Time frame: 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)
Depression
Time frame: 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)
Menstrual cycle, self reported
Time frame: 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)
Eating behavior; binge eating behavior
Time frame: 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)
Training volume, self reported
Time frame: Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)
Training history, self reported
Time frame: 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)
Eating disorders, history
Time frame: 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)
Drive for Leanness
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Derived from this study: PubMed 29415831Mathisen 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.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be available to other than the research group.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorunn K Sundgot-Borgen, Professor study director
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resting Metabolic Rate and Bone Mineral Density, Low, Susceptibility to, run by Norwegian School of Sport Sciences at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03007459, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.