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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03007459
Other study ID # 3281
Secondary ID
Status Completed
Phase
First received December 24, 2016
Last updated March 28, 2018
Start date November 2016
Est. completion date December 2017

Study information

Verified date March 2018
Source Norwegian School of Sport Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 active female population.


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.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date December 2017
Est. primary completion date November 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design


Intervention

Other:
Psychological health
Observing and measuring baseline, and changes in, psychological health through a fitness contest preparation period
Physiological health
Observing and measuring baseline, and changes in, physiological health through a fitness contest preparation period

Locations

Country Name City State
Norway Norwegian School of Sports Sciences Oslo

Sponsors (2)

Lead Sponsor Collaborator
Norwegian School of Sport Sciences National Dairy Council

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Secondary 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 Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Secondary 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) Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Secondary 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) Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Secondary 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) Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Secondary 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) Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Secondary 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) Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Secondary 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) Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Secondary 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) Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Secondary 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) Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Secondary 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) Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Secondary 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) Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Secondary Depression 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)
Secondary 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) Each 2nd week during the 3 month contest dieting period (between pre-test and mid-test)
Secondary Menstrual cycle, self reported 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)
Secondary Eating disordered behavior 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)
Secondary Eating behavior; binge eating behavior 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)
Secondary Eating behavior; restrictive eating and sensation of hunger 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)
Secondary Training volume, self reported 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)
Secondary Training history, self reported Reporting experience with training, giving details on specific sport activity and typical intensity Retrospective
Secondary Dietary Supplements 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)
Secondary Eating disorders, history Reporting previous eating disorder and whether treatment were recieved or not Retrospective
Secondary 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) Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Secondary 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) Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)
Secondary Body Weight, history Reporting lowest and highest bodyweight after 18 yr's of age (excluding periods of pregnancy) Retrospective
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