Female Athlete Body Project (FAB)

This study is currently recruiting participants.
Verified January 2014 by Pennington Biomedical Research Center
Sponsor:
Information provided by (Responsible Party):
Tiffany Stewart, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01735994
First received: November 14, 2012
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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 Intervention
Eating Disorders
Female Athlete Triad
Behavioral: Healthy Weight
Other: Brochure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Healthy Weight Intervention in Female Athletes: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Eating disorder symptoms [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Eating Disorder symptoms

  • Body image [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    shape and weight concern


Secondary Outcome Measures:
  • knowledge and identification of the female athlete triad [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    knowledge and identification of the female athlete triad

  • negative affect [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    negative affect

  • treatment seeking for the triad [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    treatment seeking for the triad


Estimated Enrollment: 500
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Brochure

Detailed Description:

Given the cost of treating eating disorders (EDs) and the substantial morbidity and mortality associated with these disorders, prevention of EDs has considerable public health significance. 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 two years for the HW condition only.

  Eligibility

Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735994

Locations
United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Tiffany Stewart       stewartm@pbrc.edu   
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
Principal Investigator: Tiffany M Stewart, PhD Pennington Biomedical
  More Information

No publications provided

Responsible Party: Tiffany Stewart, Director, Behavior Technology Laboratory, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01735994     History of Changes
Other Study ID Numbers: PBRC11032
Study First Received: November 14, 2012
Last Updated: January 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
Eating disorders
body image
female athletes
female athlete triad
eating disorder prevention
cluster randomization

Additional relevant MeSH terms:
Eating Disorders
Female Athlete Triad Syndrome
Mental Disorders
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014