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Efficacy of the Female Athlete Body Project (FAB)

Healthy Weight Intervention in Female Athletes: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01735994
Acronym
FAB
Enrollment
481
Registered
2012-11-28
Start date
2012-11-30
Completion date
2018-12-31
Last updated
2019-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eating Disorders, Female Athlete Triad

Keywords

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

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.

Interventions

BEHAVIORALHealthy Weight

Eating Disorder Prevention Program for Athletes

OTHERBrochure

Brochure on the Female athlete triad

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Pennington Biomedical Research Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Eating Disorder Examination Questionnaire (EDE-Q)18 monthsThe 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)18 monthsFrequency of subjective and objective binge episodes is reported.

Secondary

MeasureTime frameDescription
Secondary Outcomes18 monthsInternalization 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 - BMI18 monthsBody Mass Index (BMI) (self-reported) is a measure of kg/m\^2.

Countries

United States

Participant flow

Recruitment details

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

Pre-assignment details

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

Participants by arm

ArmCount
Healthy Weight Intervention
Eating Disorder Prevention Program Healthy Weight: Eating Disorder Prevention Program for Athletes
263
Brochure Wait List
Brochure wait list control group Brochure: Brochure on the Female athlete triad
218
Total481

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyInjury20
Overall StudyKicked off team50
Overall StudyLost to Follow-up5062
Overall StudyWithdrawal by Subject64

Baseline characteristics

CharacteristicHealthy Weight InterventionTotalBrochure Wait List
Age, Continuous19.29 years
STANDARD_DEVIATION 1.25
19.35 years
STANDARD_DEVIATION 1.22
19.42 years
STANDARD_DEVIATION 1.18
BMI22.74 kg/m^2
STANDARD_DEVIATION 3.01
22.50 kg/m^2
STANDARD_DEVIATION 2.86
22.23 kg/m^2
STANDARD_DEVIATION 2.65
Ethnicity (NIH/OMB)
Hispanic or Latino
37 Participants64 Participants27 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
205 Participants388 Participants183 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
21 Participants29 Participants8 Participants
Height (inches)65.95 inches
STANDARD_DEVIATION 3.39
66.05 inches
STANDARD_DEVIATION 3.68
66.18 inches
STANDARD_DEVIATION 4
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants5 Participants3 Participants
Race (NIH/OMB)
Asian
7 Participants9 Participants2 Participants
Race (NIH/OMB)
Black or African American
43 Participants71 Participants28 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
3 Participants6 Participants3 Participants
Race (NIH/OMB)
Unknown or Not Reported
15 Participants26 Participants11 Participants
Race (NIH/OMB)
White
193 Participants364 Participants171 Participants
Sex: Female, Male
Female
263 Participants481 Participants218 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Weight (pounds)140.80 pounds
STANDARD_DEVIATION 22.47
139.90 pounds
STANDARD_DEVIATION 23.04
138.80 pounds
STANDARD_DEVIATION 23.72

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2630 / 218
other
Total, other adverse events
0 / 2630 / 218
serious
Total, serious adverse events
0 / 2630 / 218

Outcome results

Primary

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.

Time frame: 18 months

ArmMeasureGroupValue (MEAN)Dispersion
Healthy Weight InterventionEating Disorder Examination Questionnaire (EDE-Q)Global.98 units on a scaleStandard Error 0.17
Healthy Weight InterventionEating Disorder Examination Questionnaire (EDE-Q)Weight Concern1.03 units on a scaleStandard Error 0.26
Healthy Weight InterventionEating Disorder Examination Questionnaire (EDE-Q)Shape Concern1.13 units on a scaleStandard Error 0.21
Healthy Weight InterventionEating Disorder Examination Questionnaire (EDE-Q)Eating Concern.49 units on a scaleStandard Error 0.16
Healthy Weight InterventionEating Disorder Examination Questionnaire (EDE-Q)Restraint.54 units on a scaleStandard Error 0.11
Brochure Wait ListEating Disorder Examination Questionnaire (EDE-Q)Eating Concern.55 units on a scaleStandard Error 0.15
Brochure Wait ListEating Disorder Examination Questionnaire (EDE-Q)Global1.24 units on a scaleStandard Error 0.16
Brochure Wait ListEating Disorder Examination Questionnaire (EDE-Q)Shape Concern1.46 units on a scaleStandard Error 0.28
Brochure Wait ListEating Disorder Examination Questionnaire (EDE-Q)Weight Concern1.17 units on a scaleStandard Error 0.24
Brochure Wait ListEating Disorder Examination Questionnaire (EDE-Q)Restraint.84 units on a scaleStandard Error 0.18
Primary

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.

Time frame: 18 months

ArmMeasureGroupValue (MEAN)Dispersion
Healthy Weight InterventionNumber of Subjective and Objective Binge Episodes as Measured by the Eating Disorder Examination Questionnaire (EDE-Q)Objective Binge Episode Frequency.35 episodesStandard Error 1.56
Healthy Weight InterventionNumber of Subjective and Objective Binge Episodes as Measured by the Eating Disorder Examination Questionnaire (EDE-Q)Subjective Binge Episode Frequency.49 episodesStandard Error 1.94
Brochure Wait ListNumber of Subjective and Objective Binge Episodes as Measured by the Eating Disorder Examination Questionnaire (EDE-Q)Objective Binge Episode Frequency.63 episodesStandard Error 1.75
Brochure Wait ListNumber of Subjective and Objective Binge Episodes as Measured by the Eating Disorder Examination Questionnaire (EDE-Q)Subjective Binge Episode Frequency.57 episodesStandard Error 3.52
Secondary

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).

Time frame: 18 months

ArmMeasureGroupValue (MEAN)Dispersion
Healthy Weight InterventionSecondary OutcomesInternalization of the Sport-Specific Thin-Ideal2.46 score on a scaleStandard Error 0.18
Healthy Weight InterventionSecondary OutcomesTeammate Relationship Health (TRH)30.28 score on a scaleStandard Error 0.65
Healthy Weight InterventionSecondary OutcomesIdeal-Body Stereotype Scale - Revised (IBSSR)3.20 score on a scaleStandard Error 0.06
Healthy Weight InterventionSecondary OutcomesPositive and Negative Affect Scale - Revised1.50 score on a scaleStandard Error 0.04
Healthy Weight InterventionSecondary OutcomesIntervention Suitability Expectations (ISE)29.92 score on a scaleStandard Error 7.8
Healthy Weight InterventionSecondary OutcomesKnowledge of the Female Athlete Triad8.54 score on a scaleStandard Error 0.37
Brochure Wait ListSecondary OutcomesIntervention Suitability Expectations (ISE)26.50 score on a scaleStandard Error 8.52
Brochure Wait ListSecondary OutcomesTeammate Relationship Health (TRH)29.87 score on a scaleStandard Error 0.85
Brochure Wait ListSecondary OutcomesInternalization of the Sport-Specific Thin-Ideal2.71 score on a scaleStandard Error 0.31
Brochure Wait ListSecondary OutcomesPositive and Negative Affect Scale - Revised1.59 score on a scaleStandard Error 0.06
Brochure Wait ListSecondary OutcomesKnowledge of the Female Athlete Triad8.58 score on a scaleStandard Error 0.3
Brochure Wait ListSecondary OutcomesIdeal-Body Stereotype Scale - Revised (IBSSR)3.43 score on a scaleStandard Error 0.05
Secondary

Secondary Outcomes - BMI

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

Time frame: 18 months

ArmMeasureValue (MEAN)Dispersion
Healthy Weight InterventionSecondary Outcomes - BMI25.09 kg/m^2Standard Error 1.12
Brochure Wait ListSecondary Outcomes - BMI24.22 kg/m^2Standard Error 0.9

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026