Eating Disorders, Female Athlete Triad
Conditions
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
Eating Disorder Prevention Program for Athletes
Brochure on the Female athlete triad
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Eating Disorder Examination Questionnaire (EDE-Q) | 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. |
| Number of Subjective and Objective Binge Episodes as Measured by the Eating Disorder Examination Questionnaire (EDE-Q) | 18 months | Frequency of subjective and objective binge episodes is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcomes | 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). |
| Secondary Outcomes - BMI | 18 months | Body 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
| Arm | Count |
|---|---|
| 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 |
| Total | 481 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Injury | 2 | 0 |
| Overall Study | Kicked off team | 5 | 0 |
| Overall Study | Lost to Follow-up | 50 | 62 |
| Overall Study | Withdrawal by Subject | 6 | 4 |
Baseline characteristics
| Characteristic | Healthy Weight Intervention | Total | Brochure Wait List |
|---|---|---|---|
| Age, Continuous | 19.29 years STANDARD_DEVIATION 1.25 | 19.35 years STANDARD_DEVIATION 1.22 | 19.42 years STANDARD_DEVIATION 1.18 |
| BMI | 22.74 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 Participants | 64 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 205 Participants | 388 Participants | 183 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 21 Participants | 29 Participants | 8 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 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 9 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 43 Participants | 71 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants | 26 Participants | 11 Participants |
| Race (NIH/OMB) White | 193 Participants | 364 Participants | 171 Participants |
| Sex: Female, Male Female | 263 Participants | 481 Participants | 218 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 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 type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 263 | 0 / 218 |
| other Total, other adverse events | 0 / 263 | 0 / 218 |
| serious Total, serious adverse events | 0 / 263 | 0 / 218 |
Outcome results
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Weight Intervention | Eating Disorder Examination Questionnaire (EDE-Q) | Global | .98 units on a scale | Standard Error 0.17 |
| Healthy Weight Intervention | Eating Disorder Examination Questionnaire (EDE-Q) | Weight Concern | 1.03 units on a scale | Standard Error 0.26 |
| Healthy Weight Intervention | Eating Disorder Examination Questionnaire (EDE-Q) | Shape Concern | 1.13 units on a scale | Standard Error 0.21 |
| Healthy Weight Intervention | Eating Disorder Examination Questionnaire (EDE-Q) | Eating Concern | .49 units on a scale | Standard Error 0.16 |
| Healthy Weight Intervention | Eating Disorder Examination Questionnaire (EDE-Q) | Restraint | .54 units on a scale | Standard Error 0.11 |
| Brochure Wait List | Eating Disorder Examination Questionnaire (EDE-Q) | Eating Concern | .55 units on a scale | Standard Error 0.15 |
| Brochure Wait List | Eating Disorder Examination Questionnaire (EDE-Q) | Global | 1.24 units on a scale | Standard Error 0.16 |
| Brochure Wait List | Eating Disorder Examination Questionnaire (EDE-Q) | Shape Concern | 1.46 units on a scale | Standard Error 0.28 |
| Brochure Wait List | Eating Disorder Examination Questionnaire (EDE-Q) | Weight Concern | 1.17 units on a scale | Standard Error 0.24 |
| Brochure Wait List | Eating Disorder Examination Questionnaire (EDE-Q) | Restraint | .84 units on a scale | Standard Error 0.18 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Weight Intervention | 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 |
| Healthy Weight Intervention | 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 |
| Brochure Wait List | Number of Subjective and Objective Binge Episodes as Measured by the Eating Disorder Examination Questionnaire (EDE-Q) | Objective Binge Episode Frequency | .63 episodes | Standard Error 1.75 |
| Brochure Wait List | Number of Subjective and Objective Binge Episodes as Measured by the Eating Disorder Examination Questionnaire (EDE-Q) | Subjective Binge Episode Frequency | .57 episodes | Standard Error 3.52 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Weight Intervention | Secondary Outcomes | Internalization of the Sport-Specific Thin-Ideal | 2.46 score on a scale | Standard Error 0.18 |
| Healthy Weight Intervention | Secondary Outcomes | Teammate Relationship Health (TRH) | 30.28 score on a scale | Standard Error 0.65 |
| Healthy Weight Intervention | Secondary Outcomes | Ideal-Body Stereotype Scale - Revised (IBSSR) | 3.20 score on a scale | Standard Error 0.06 |
| Healthy Weight Intervention | Secondary Outcomes | Positive and Negative Affect Scale - Revised | 1.50 score on a scale | Standard Error 0.04 |
| Healthy Weight Intervention | Secondary Outcomes | Intervention Suitability Expectations (ISE) | 29.92 score on a scale | Standard Error 7.8 |
| Healthy Weight Intervention | Secondary Outcomes | Knowledge of the Female Athlete Triad | 8.54 score on a scale | Standard Error 0.37 |
| Brochure Wait List | Secondary Outcomes | Intervention Suitability Expectations (ISE) | 26.50 score on a scale | Standard Error 8.52 |
| Brochure Wait List | Secondary Outcomes | Teammate Relationship Health (TRH) | 29.87 score on a scale | Standard Error 0.85 |
| Brochure Wait List | Secondary Outcomes | Internalization of the Sport-Specific Thin-Ideal | 2.71 score on a scale | Standard Error 0.31 |
| Brochure Wait List | Secondary Outcomes | Positive and Negative Affect Scale - Revised | 1.59 score on a scale | Standard Error 0.06 |
| Brochure Wait List | Secondary Outcomes | Knowledge of the Female Athlete Triad | 8.58 score on a scale | Standard Error 0.3 |
| Brochure Wait List | Secondary Outcomes | Ideal-Body Stereotype Scale - Revised (IBSSR) | 3.43 score on a scale | Standard Error 0.05 |
Secondary Outcomes - BMI
Body Mass Index (BMI) (self-reported) is a measure of kg/m\^2.
Time frame: 18 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Weight Intervention | Secondary Outcomes - BMI | 25.09 kg/m^2 | Standard Error 1.12 |
| Brochure Wait List | Secondary Outcomes - BMI | 24.22 kg/m^2 | Standard Error 0.9 |