- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01735994
Efficacy of the Female Athlete Body Project (FAB) (FAB)
Healthy Weight Intervention in Female Athletes: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy Weight Intervention
Eating Disorder Prevention Program
|
Eating Disorder Prevention Program for Athletes
|
Other: Brochure wait list
Brochure wait list control group
|
Brochure on the Female athlete triad
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eating Disorder Examination Questionnaire (EDE-Q)
Time Frame: 18 months
|
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)
Time Frame: 18 months
|
Frequency of subjective and objective binge episodes is reported.
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary Outcomes
Time Frame: 18 months
|
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). |
18 months
|
Secondary Outcomes - BMI
Time Frame: 18 months
|
Body Mass Index (BMI) (self-reported) is a measure of kg/m^2.
|
18 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Tiffany M Stewart, PhD, Pennington Biomedical
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC 11032
- R01MH094448 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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