Efficacy of the Female Athlete Body Project (FAB) (FAB)
Primary Purpose
Eating Disorders, Female Athlete Triad
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Weight
Brochure
Sponsored by
About this trial
This is an interventional prevention trial for Eating Disorders focused on measuring Eating disorders, body image, female athletes, female athlete triad, eating disorder prevention, cluster randomization, risk factors, prevention
Eligibility 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
Sites / Locations
- Pennington Biomedical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Healthy Weight Intervention
Brochure wait list
Arm Description
Eating Disorder Prevention Program
Brochure wait list control group
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Secondary Outcomes
Internalization of the Sport-Specific Thin-Ideal (ISTI) measures thin-ideal internalization specific to athletes (average of items from 1-5; higher scores mean worse outcome).
Teammate Relationship Health (TRH) measures relational health with teammates (scores from 8-40; higher scores mean better outcome).
Ideal-Body Stereotype Scale - Revised (IBSS-R) assesses internalization of the traditional thin-ideal (scores from 1-10, higher scores mean worse outcome).
Positive and Negative Affect Scale - Revised (PANAS-X) assesses negative affect (average of items from 1-5; higher scores mean worse outcome).
Intervention Suitability Expectations (ISE) assesses perceived suitability and expectations of the intervention (average of total scores from 4-46; higher scores mean better outcome).
Knowledge of the Female Athlete Triad (KFAT) measures participant understanding of the Female Athlete Triad (each correct answer = 1, scores from 0-10; higher scores mean better outcome).
Secondary Outcomes - BMI
Body Mass Index (BMI) (self-reported) is a measure of kg/m^2.
Full Information
NCT ID
NCT01735994
First Posted
November 14, 2012
Last Updated
November 12, 2019
Sponsor
Pennington Biomedical Research Center
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01735994
Brief Title
Efficacy of the Female Athlete Body Project (FAB)
Acronym
FAB
Official Title
Healthy Weight Intervention in Female Athletes: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 to evaluate 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. Based on previous promising findings, the department of athletics involved in the study have chosen to implement HW to all athletics teams on a mandatory basis on a staggered schedule. Given that it is unethical to require human subjects to participate in research, the proposed study (i.e., the study) must be separated from the program (i.e., the athlete prevention program) it aims to assess. Thus, the overall study will evaluate (via assessment measures) the program that the departments of athletics deliver at three sites, i.e. LSU, TU/IW, and AU.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders, Female Athlete Triad
Keywords
Eating disorders, body image, female athletes, female athlete triad, eating disorder prevention, cluster randomization, risk factors, prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
481 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Weight Intervention
Arm Type
Experimental
Arm Description
Eating Disorder Prevention Program
Arm Title
Brochure wait list
Arm Type
Other
Arm Description
Brochure wait list control group
Intervention Type
Behavioral
Intervention Name(s)
Healthy Weight
Intervention Description
Eating Disorder Prevention Program for Athletes
Intervention Type
Other
Intervention Name(s)
Brochure
Intervention Description
Brochure on the Female athlete triad
Primary Outcome Measure Information:
Title
Eating Disorder Examination Questionnaire (EDE-Q)
Description
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.
Time Frame
18 months
Title
Number of Subjective and Objective Binge Episodes as Measured by the Eating Disorder Examination Questionnaire (EDE-Q)
Description
Frequency of subjective and objective binge episodes is reported.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Secondary Outcomes
Description
Internalization of the Sport-Specific Thin-Ideal (ISTI) measures thin-ideal internalization specific to athletes (average of items from 1-5; higher scores mean worse outcome).
Teammate Relationship Health (TRH) measures relational health with teammates (scores from 8-40; higher scores mean better outcome).
Ideal-Body Stereotype Scale - Revised (IBSS-R) assesses internalization of the traditional thin-ideal (scores from 1-10, higher scores mean worse outcome).
Positive and Negative Affect Scale - Revised (PANAS-X) assesses negative affect (average of items from 1-5; higher scores mean worse outcome).
Intervention Suitability Expectations (ISE) assesses perceived suitability and expectations of the intervention (average of total scores from 4-46; higher scores mean better outcome).
Knowledge of the Female Athlete Triad (KFAT) measures participant understanding of the Female Athlete Triad (each correct answer = 1, scores from 0-10; higher scores mean better outcome).
Time Frame
18 months
Title
Secondary Outcomes - BMI
Description
Body Mass Index (BMI) (self-reported) is a measure of kg/m^2.
Time Frame
18 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiffany M Stewart, PhD
Organizational Affiliation
Pennington Biomedical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28611008
Citation
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.
Results Reference
background
PubMed Identifier
31350934
Citation
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.
Results Reference
background
PubMed Identifier
33952348
Citation
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.
Results Reference
derived
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Efficacy of the Female Athlete Body Project (FAB)
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