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

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ClinicalTrials.gov Identifier: NCT01735994
Recruitment Status : Active, not recruiting
First Posted : November 28, 2012
Last Update Posted : April 4, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Tiffany Stewart, Pennington Biomedical Research Center

Tracking Information
First Submitted Date  ICMJE November 14, 2012
First Posted Date  ICMJE November 28, 2012
Last Update Posted Date April 4, 2018
Study Start Date  ICMJE November 2012
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2016)
  • Eating Disorder risk factors [ Time Frame: 18 months ]
    Eating Disorder behaviors
  • Body image [ Time Frame: 18 months ]
    shape and weight concern
Original Primary Outcome Measures  ICMJE
 (submitted: November 27, 2012)
  • Eating disorder symptoms [ Time Frame: 18 months ]
    Eating Disorder symptoms
  • Body image [ Time Frame: 18 months ]
    shape and weight concern
Change History Complete list of historical versions of study NCT01735994 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2012)
  • Knowledge and identification of the female athlete triad [ Time Frame: 18 months ]
    knowledge and identification of the female athlete triad
  • Negative affect [ Time Frame: 18 months ]
    negative affect
  • Treatment seeking for the triad [ Time Frame: 18 months ]
    treatment seeking for the triad
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of the Female Athlete Body Project (FAB)
Official Title  ICMJE Healthy Weight Intervention in Female Athletes: A Randomized Controlled Trial
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Eating Disorders
  • Female Athlete Triad
Intervention  ICMJE
  • Behavioral: Healthy Weight
    Eating Disorder Prevention Program for Athletes
  • Other: Brochure
    Brochure on the Female athlete triad
Study Arms  ICMJE
  • Experimental: Healthy Weight Intervention
    Eating Disorder Prevention Program
    Intervention: Behavioral: Healthy Weight
  • Brochure wait list
    Brochure wait list control group
    Intervention: Other: Brochure
Publications * Stewart TM, Pollard T, Hildebrandt T, Wesley NY, Kilpela LS, Becker CB. The Female Athlete Body project study: 18-month outcomes in eating disorder symptoms and risk factors. Int J Eat Disord. 2019 Jul 27. doi: 10.1002/eat.23145. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 11, 2016)
481
Original Estimated Enrollment  ICMJE
 (submitted: November 27, 2012)
500
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01735994
Other Study ID Numbers  ICMJE PBRC 11032
R01MH094448 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tiffany Stewart, Pennington Biomedical Research Center
Study Sponsor  ICMJE Pennington Biomedical Research Center
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Tiffany M Stewart, PhD Pennington Biomedical
PRS Account Pennington Biomedical Research Center
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP