Trial Outcomes & Findings for Efficacy of the Female Athlete Body Project (FAB) (NCT NCT01735994)

Last Updated: 2019-12-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

481 participants

Primary outcome timeframe

18 months

Results posted on

2019-12-04

Participant Flow

Study enrollment began at the schools in August 2012 and completed in October 2014.

Only one athlete decided to participate in the prevention program without participating in the study.

Unit of analysis: teams

Participant milestones

Participant milestones
Measure	Healthy Weight Intervention Eating Disorder Prevention Program Healthy Weight: Eating Disorder Prevention Program for Athletes	Brochure Wait List Brochure wait list control group Brochure: Brochure on the Female athlete triad
Overall Study STARTED	263 13	218 15
Overall Study Post Intervention (3 Weeks)	239 13	198 15
Overall Study Follow-Up #1 (6 Months)	213 13	163 15
Overall Study Follow-Up #2 (12 Months)	212 13	174 15
Overall Study COMPLETED	200 13	152 15
Overall Study NOT COMPLETED	63 0	66 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Healthy Weight Intervention Eating Disorder Prevention Program Healthy Weight: Eating Disorder Prevention Program for Athletes	Brochure Wait List Brochure wait list control group Brochure: Brochure on the Female athlete triad
Overall Study Withdrawal by Subject	6	4
Overall Study Injury	2	0
Overall Study Kicked off team	5	0
Overall Study Lost to Follow-up	50	62

Baseline Characteristics

Efficacy of the Female Athlete Body Project (FAB)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Weight Intervention n=263 Participants Eating Disorder Prevention Program Healthy Weight: Eating Disorder Prevention Program for Athletes	Brochure Wait List n=218 Participants Brochure wait list control group Brochure: Brochure on the Female athlete triad	Total n=481 Participants Total of all reporting groups
Age, Continuous	19.29 years STANDARD_DEVIATION 1.25 • n=5 Participants	19.42 years STANDARD_DEVIATION 1.18 • n=7 Participants	19.35 years STANDARD_DEVIATION 1.22 • n=5 Participants
Sex: Female, Male Female	263 Participants n=5 Participants	218 Participants n=7 Participants	481 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	37 Participants n=5 Participants	27 Participants n=7 Participants	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	205 Participants n=5 Participants	183 Participants n=7 Participants	388 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	21 Participants n=5 Participants	8 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Black or African American	43 Participants n=5 Participants	28 Participants n=7 Participants	71 Participants n=5 Participants
Race (NIH/OMB) White	193 Participants n=5 Participants	171 Participants n=7 Participants	364 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Height (inches)	65.95 inches STANDARD_DEVIATION 3.39 • n=5 Participants	66.18 inches STANDARD_DEVIATION 4.00 • n=7 Participants	66.05 inches STANDARD_DEVIATION 3.68 • n=5 Participants
Weight (pounds)	140.80 pounds STANDARD_DEVIATION 22.47 • n=5 Participants	138.80 pounds STANDARD_DEVIATION 23.72 • n=7 Participants	139.90 pounds STANDARD_DEVIATION 23.04 • n=5 Participants
BMI	22.74 kg/m^2 STANDARD_DEVIATION 3.01 • n=5 Participants	22.23 kg/m^2 STANDARD_DEVIATION 2.65 • n=7 Participants	22.50 kg/m^2 STANDARD_DEVIATION 2.86 • n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Outcome measures

Outcome measures
Measure	Healthy Weight Intervention n=263 Participants Eating Disorder Prevention Program Healthy Weight: Eating Disorder Prevention Program for Athletes	Brochure Wait List n=218 Participants Brochure wait list control group Brochure: Brochure on the Female athlete triad
Eating Disorder Examination Questionnaire (EDE-Q) Global	.98 units on a scale Standard Error .17	1.24 units on a scale Standard Error .16
Eating Disorder Examination Questionnaire (EDE-Q) Restraint	.54 units on a scale Standard Error .11	.84 units on a scale Standard Error .18
Eating Disorder Examination Questionnaire (EDE-Q) Shape Concern	1.13 units on a scale Standard Error .21	1.46 units on a scale Standard Error .28
Eating Disorder Examination Questionnaire (EDE-Q) Weight Concern	1.03 units on a scale Standard Error .26	1.17 units on a scale Standard Error .24
Eating Disorder Examination Questionnaire (EDE-Q) Eating Concern	.49 units on a scale Standard Error .16	.55 units on a scale Standard Error .15

PRIMARY outcome

Timeframe: 18 months

Frequency of subjective and objective binge episodes is reported.

Outcome measures

Outcome measures
Measure	Healthy Weight Intervention n=263 Participants Eating Disorder Prevention Program Healthy Weight: Eating Disorder Prevention Program for Athletes	Brochure Wait List n=218 Participants Brochure wait list control group Brochure: Brochure on the Female athlete triad
Number of Subjective and Objective Binge Episodes as Measured by the Eating Disorder Examination Questionnaire (EDE-Q) Objective Binge Episode Frequency	.35 episodes Standard Error 1.56	.63 episodes Standard Error 1.75
Number of Subjective and Objective Binge Episodes as Measured by the Eating Disorder Examination Questionnaire (EDE-Q) Subjective Binge Episode Frequency	.49 episodes Standard Error 1.94	.57 episodes Standard Error 3.52

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Healthy Weight Intervention n=263 Participants Eating Disorder Prevention Program Healthy Weight: Eating Disorder Prevention Program for Athletes	Brochure Wait List n=218 Participants Brochure wait list control group Brochure: Brochure on the Female athlete triad
Secondary Outcomes Internalization of the Sport-Specific Thin-Ideal	2.46 score on a scale Standard Error .18	2.71 score on a scale Standard Error .31
Secondary Outcomes Teammate Relationship Health (TRH)	30.28 score on a scale Standard Error .65	29.87 score on a scale Standard Error .85
Secondary Outcomes Ideal-Body Stereotype Scale - Revised (IBSSR)	3.20 score on a scale Standard Error .06	3.43 score on a scale Standard Error .05
Secondary Outcomes Positive and Negative Affect Scale - Revised	1.50 score on a scale Standard Error .04	1.59 score on a scale Standard Error .06
Secondary Outcomes Intervention Suitability Expectations (ISE)	29.92 score on a scale Standard Error 7.80	26.50 score on a scale Standard Error 8.52
Secondary Outcomes Knowledge of the Female Athlete Triad	8.54 score on a scale Standard Error .37	8.58 score on a scale Standard Error .30

SECONDARY outcome

Timeframe: 18 months

Body Mass Index (BMI) (self-reported) is a measure of kg/m\^2.

Outcome measures

Outcome measures
Measure	Healthy Weight Intervention n=263 Participants Eating Disorder Prevention Program Healthy Weight: Eating Disorder Prevention Program for Athletes	Brochure Wait List n=218 Participants Brochure wait list control group Brochure: Brochure on the Female athlete triad
Secondary Outcomes - BMI	25.09 kg/m^2 Standard Error 1.12	24.22 kg/m^2 Standard Error .90

Adverse Events

Healthy Weight Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Brochure Wait List

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Tiffany Stewart, Director, Behavior Technology Laboratory

Pennington Biomedical Research Center

Phone: 2257632554

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place