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Efficacy of the Female Athlete Body Project (FAB) (FAB)

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ClinicalTrials.gov Identifier: NCT01735994
Recruitment Status : Completed
First Posted : November 28, 2012
Results First Posted : December 4, 2019
Last Update Posted : December 4, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Tiffany Stewart, Pennington Biomedical Research Center

Brief Summary:
Given the cost of treating eating disorders and the substantial morbidity and mortality associated with these disorders, prevention of eating disorders has considerable public health significance. Female athletes represent an important population for prevention due to their risk for the Female Athlete Triad, which includes inadequate energy intake, irregular or cessation of menses, and osteoporosis. The proposed randomized controlled trial will provide important information regarding the efficacy, acceptability, and feasibility of implementing a brief eating disorder prevention and healthy living program within an existing social system of female athletes.

Condition or disease Intervention/treatment Phase
Eating Disorders Female Athlete Triad Behavioral: Healthy Weight Other: Brochure Not Applicable

Detailed Description:
Research supports the use of a Healthy Weight (HW) program targeting small lifestyle modifications in the prevention of ED onset and in reducing ED risk factors. Studies show that HW can be tailored for specific social systems (e.g., sororities) which can facilitate dissemination and that undergraduate peer-leaders can implement these programs. Interventions that can be administered affordably by endogenous providers are more likely to be disseminated, as indicated by the large scale dissemination of a peer-led ED prevention program by a national sorority. Another target social system for dissemination of ED prevention is collegiate athletics. Research suggests that disordered eating among female athletes is prevalent, and that this group is at greater, or at least equal, risk for developing EDs as non-athlete females. Disordered eating is especially dangerous in female athletes because it increases risk for the Female Athlete Triad (i.e., low energy availability/disordered eating, menstrual disorders, and decreased bone mineral density/osteoporosis) and subsequent injury. Moreover, the triad puts athletes at risk for serious long-term health consequences, such as osteoporosis, reproductive disorders, and cardiovascular disease. Despite this, efforts aimed at prevention of EDs among this group remain surprisingly limited. A pilot study with female athletes suggests that a modified version of HW can be successfully implemented by peer-leaders within the constraints of a competitive athletics program with positive effects at 12 month follow-up. The proposed study is to evaluate a randomized controlled trial of the HW intervention among female athletes. 500 female collegiate athletes from three sites will be randomized to either the HW prevention program or a brochure waitlist control condition using group (cluster) randomization based on teams. Participants will complete surveys and telephone interviews at pretest, posttest, and at 6 and 12 month follow-ups. The investigators will examine; (1) the efficacy of HW in reducing empirically supported ED risk factors relative to a waitlist brochure control condition at one year, (2) whether HW impacts secondary outcomes, including knowledge and identification of the female athlete triad, treatment seeking for the triad, affect, and health care utilization, and (3) whether positive effects for HW replicate the effects from the pilot study at one year and 18 months for the HW condition only. Based on previous promising findings, the department of athletics involved in the study have chosen to implement HW to all athletics teams on a mandatory basis on a staggered schedule. Given that it is unethical to require human subjects to participate in research, the proposed study (i.e., the study) must be separated from the program (i.e., the athlete prevention program) it aims to assess. Thus, the overall study will evaluate (via assessment measures) the program that the departments of athletics deliver at three sites, i.e. LSU, TU/IW, and AU.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 481 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Healthy Weight Intervention in Female Athletes: A Randomized Controlled Trial
Study Start Date : November 2012
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Healthy Weight Intervention
Eating Disorder Prevention Program
Behavioral: Healthy Weight
Eating Disorder Prevention Program for Athletes

Brochure wait list
Brochure wait list control group
Other: Brochure
Brochure on the Female athlete triad




Primary Outcome Measures :
  1. Eating Disorder Examination Questionnaire (EDE-Q) [ Time Frame: 18 months ]
    The Eating Disorder Examination Questionnaire (EDE-Q) assesses eating disorder behaviors through a self-report questionnaire. There are four subscales of the EDE-Q--Restraint, Eating Concern, Shape Concern, and Weight Concern--with scores for each ranging from 0-6. Overall scores also range from 0-6. Higher scores reflect greater severity of eating disorder psychopathology. Subscales are averaged to compute a total score.

  2. Number of Subjective and Objective Binge Episodes as Measured by the Eating Disorder Examination Questionnaire (EDE-Q) [ Time Frame: 18 months ]
    Frequency of subjective and objective binge episodes is reported.


Secondary Outcome Measures :
  1. Secondary Outcomes [ Time Frame: 18 months ]

    Internalization of the Sport-Specific Thin-Ideal (ISTI) measures thin-ideal internalization specific to athletes (average of items from 1-5; higher scores mean worse outcome).

    Teammate Relationship Health (TRH) measures relational health with teammates (scores from 8-40; higher scores mean better outcome).

    Ideal-Body Stereotype Scale - Revised (IBSS-R) assesses internalization of the traditional thin-ideal (scores from 1-10, higher scores mean worse outcome).

    Positive and Negative Affect Scale - Revised (PANAS-X) assesses negative affect (average of items from 1-5; higher scores mean worse outcome).

    Intervention Suitability Expectations (ISE) assesses perceived suitability and expectations of the intervention (average of total scores from 4-46; higher scores mean better outcome).

    Knowledge of the Female Athlete Triad (KFAT) measures participant understanding of the Female Athlete Triad (each correct answer = 1, scores from 0-10; higher scores mean better outcome).


  2. Secondary Outcomes - BMI [ Time Frame: 18 months ]
    Body Mass Index (BMI) (self-reported) is a measure of kg/m^2.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • Member of a University-sponsored athletic team,
  • Are willing and able to provide informed consent, attend all study visits, and comply with the study protocol

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735994


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Tiffany M Stewart, PhD Pennington Biomedical
  Study Documents (Full-Text)

Documents provided by Tiffany Stewart, Pennington Biomedical Research Center:
Study Protocol  [PDF] July 10, 2013
Informed Consent Form  [PDF] July 10, 2013
Statistical Analysis Plan  [PDF] September 4, 2019

Publications:
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Responsible Party: Tiffany Stewart, Director, Behavior Technology Laboratory, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01735994    
Other Study ID Numbers: PBRC 11032
R01MH094448 ( U.S. NIH Grant/Contract )
First Posted: November 28, 2012    Key Record Dates
Results First Posted: December 4, 2019
Last Update Posted: December 4, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tiffany Stewart, Pennington Biomedical Research Center:
Eating disorders
body image
female athletes
female athlete triad
eating disorder prevention
cluster randomization
risk factors
prevention
Additional relevant MeSH terms:
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Female Athlete Triad Syndrome
Feeding and Eating Disorders
Mental Disorders
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Endocrine System Diseases