Clinical Trial: Efficacy of the Female Athlete Body Project (FAB)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: 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 Summary: 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 wil
Sponsor: Pennington Biomedical Research Center

Current Primary Outcome:

• Eating Disorder risk factors [ Time Frame: 18 months ]
  Eating Disorder behaviors
• Body image [ Time Frame: 18 months ]
  shape and weight concern

Original Primary Outcome:

• Eating disorder symptoms [ Time Frame: 18 months ]
  Eating Disorder symptoms
• Body image [ Time Frame: 18 months ]
  shape and weight concern

Current Secondary Outcome:

• 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: Same as current

Information By: Pennington Biomedical Research Center

Dates:
Date Received: November 14, 2012
Date Started: November 2012
Date Completion: December 2017
Last Updated: September 7, 2016
Last Verified: September 2016