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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01735994
Recruitment Status : Active, not recruiting
First Posted : November 28, 2012
Last Update Posted : April 4, 2018
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 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.

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

Resource links provided by the National Library of Medicine

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 risk factors [ Time Frame: 18 months ]
    Eating Disorder behaviors

  2. Body image [ Time Frame: 18 months ]
    shape and weight concern

Secondary Outcome Measures :
  1. Knowledge and identification of the female athlete triad [ Time Frame: 18 months ]
    knowledge and identification of the female athlete triad

  2. Negative affect [ Time Frame: 18 months ]
    negative affect

  3. Treatment seeking for the triad [ Time Frame: 18 months ]
    treatment seeking for the triad

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT01735994

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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)
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Principal Investigator: Tiffany M Stewart, PhD Pennington Biomedical

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Tiffany Stewart, Director, Behavior Technology Laboratory, Pennington Biomedical Research Center Identifier: NCT01735994     History of Changes
Other Study ID Numbers: PBRC 11032
R01MH094448 ( U.S. NIH Grant/Contract )
First Posted: November 28, 2012    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
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
Additional relevant MeSH terms:
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Female Athlete Triad Syndrome
Feeding and Eating Disorders
Mental Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Endocrine System Diseases