Efficacy of the Female Athlete Body Project (FAB)

NCT01735994 | Completed Results DMC

• 2 other identifiers: PBRC 11032R01MH094448
• Study Type: interventional
• Target: 481
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Disorders; Female Athlete Triad

Keywords

Eating disorders; body image; female athletes; female athlete triad; eating disorder prevention; cluster randomization; risk factors; prevention

Outcome Measures

Primary Outcomes (2)

• Eating Disorder Examination Questionnaire (EDE-Q)

  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.

  18 months

• Number of Subjective and Objective Binge Episodes as Measured by the Eating Disorder Examination Questionnaire (EDE-Q)

  Frequency of subjective and objective binge episodes is reported.

  18 months

Secondary Outcomes (2)

• Secondary Outcomes

  18 months

• Secondary Outcomes - BMI

  18 months

Study Arms (2)

Healthy Weight Intervention

EXPERIMENTAL

Eating Disorder Prevention Program

Behavioral: Healthy Weight

Brochure wait list

OTHER

Brochure wait list control group

Other: Brochure

Interventions

Healthy Weight BEHAVIORAL

Eating Disorder Prevention Program for Athletes

Healthy Weight Intervention

Brochure OTHER

Brochure on the Female athlete triad

Brochure wait list

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (3)

• Stewart TM, Pollard T, Hildebrandt T, Beyl R, Wesley N, Kilpela LS, Becker CB. The Female Athlete Body (FAB) study: Rationale, design, and baseline characteristics. Contemp Clin Trials. 2017 Sep;60:63-71. doi: 10.1016/j.cct.2017.06.005. Epub 2017 Jun 10.

  PMID: 28611008 BACKGROUND

• 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 Nov;52(11):1291-1300. doi: 10.1002/eat.23145. Epub 2019 Jul 27.

  PMID: 31350934 BACKGROUND

• Stewart T, Kilpela L, Wesley N, Baule K, Becker C. Psychometric properties of the contextual body image questionnaire for athletes: a replication and extension study in female collegiate athletes. J Eat Disord. 2021 May 5;9(1):59. doi: 10.1186/s40337-021-00414-8.

  PMID: 33952348 DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders; Female Athlete Triad Syndrome

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Relative Energy Deficiency in Sport

Limitations and Caveats

The cluster randomized control trial design by team reduced statistical power. We could not control for team-based variability. Selective attrition may have occurred by the intervention of school athletic medical staff.

Results Point of Contact

• Title: Dr. Tiffany Stewart, Director, Behavior Technology Laboratory
• Organization: Pennington Biomedical Research Center

tiffany.stewart@pbrc.edu

2257632554

Study Officials

• Tiffany M Stewart, PhD

  Pennington Biomedical

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Behavior Technology Laboratory

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: November 28, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 4, 2019
• Results First Posted: December 4, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)