NCT03007459

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

1 year

First QC Date

December 24, 2016

Last Update Submit

March 28, 2018

Conditions

Keywords

Body compositionBone mineral densityBinge EatingEating DisorderExercise DependencyDepressionPerfectionismBody buildingDrive for MuscularityDrive for leanness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (24)

  • Resting Metabolic Rate

    Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)

  • Bone Mineral Density

    Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)

  • Perfectionism

    Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)

  • Depression

    Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)

  • Eating disorders

    Pre-test (3 months before contest), mid-test (2 weeks before contest) and post-test (one month post-contest)

  • +19 more secondary outcomes

Study Arms (2)

Female Fitness Athletes

Psychological health and physiological health of fitness athletes

Other: Psychological healthOther: Physiological health

Female, physically active Controls

Psychological health and physiological health of female controls

Other: Psychological healthOther: Physiological health

Interventions

Observing and measuring baseline, and changes in, psychological health through a fitness contest preparation period

Female Fitness AthletesFemale, physically active Controls

Observing and measuring baseline, and changes in, physiological health through a fitness contest preparation period

Female Fitness AthletesFemale, physically active Controls

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian School of Sports Sciences

Oslo, 0806, Norway

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DepressionFeeding and Eating DisordersBulimiaMalnutrition

Interventions

Mental Health

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersHyperphagiaNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

HealthPopulation Characteristics

Study Officials

  • Jorunn K Sundgot-Borgen, Professor

    Professor

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 24, 2016

First Posted

January 2, 2017

Study Start

November 1, 2016

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

March 29, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

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

Locations