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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH094448 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Weight Intervention | Experimental | Eating Disorder Prevention Program |
|
| Brochure wait list | Other | Brochure wait list control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Weight | Behavioral | Eating Disorder Prevention Program for Athletes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 18 months |
| 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. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tiffany M Stewart, PhD | Pennington Biomedical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28611008 | Background | 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. | |
| 31350934 | Background | 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. |
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Only one athlete decided to participate in the prevention program without participating in the study.
Study enrollment began at the schools in August 2012 and completed in October 2014.
| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Weight Intervention | Eating Disorder Prevention Program Healthy Weight: Eating Disorder Prevention Program for Athletes |
| FG001 | Brochure Wait List | Brochure wait list control group Brochure: Brochure on the Female athlete triad |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Weight Intervention | Eating Disorder Prevention Program Healthy Weight: Eating Disorder Prevention Program for Athletes |
| BG001 | Brochure Wait List | Brochure wait list control group Brochure: Brochure on the Female athlete triad |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | units on a scale | 18 months |
|
Adverse event data was collected over a period of 18 months.
Because this study involved the evaluation of an athlete prevention program via assessment measures, with oversight by the school athletic department, minimal risk was anticipated in this remote study. Adverse events related to the study (questionnaires) were monitored. Participants were also monitored by the school athletic department based on their previously established protocols.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Weight Intervention | Eating Disorder Prevention Program Healthy Weight: Eating Disorder Prevention Program for Athletes |
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The cluster randomized control trial design by team reduced statistical power. We could not control for team-based variability. Selective attrition may have occurred by the intervention of school athletic medical staff.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tiffany Stewart, Director, Behavior Technology Laboratory | Pennington Biomedical Research Center | 2257632554 | tiffany.stewart@pbrc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 10, 2013 | Apr 17, 2019 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 10, 2013 | Apr 17, 2019 | ICF_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 4, 2019 | Sep 4, 2019 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D053716 | Female Athlete Triad Syndrome |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| Brochure | Other | Brochure on the Female athlete triad |
|
| 18 months |
| Secondary Outcomes - BMI | Body Mass Index (BMI) (self-reported) is a measure of kg/m^2. | 18 months |
| 33952348 | Derived | 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. |
| Kicked off team |
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| Lost to Follow-up |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Height (inches) | Mean | Standard Deviation | inches |
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| Weight (pounds) | Self-reported | Mean | Standard Deviation | pounds |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
Brochure wait list control group
Brochure: Brochure on the Female athlete triad
|
|
| 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). | Posted | Mean | Standard Error | score on a scale | 18 months |
|
|
|
| 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. | Posted | Mean | Standard Error | episodes | 18 months |
|
|
|
| Secondary | Secondary Outcomes - BMI | Body Mass Index (BMI) (self-reported) is a measure of kg/m^2. | Posted | Mean | Standard Error | kg/m^2 | 18 months |
|
|
|
| 0 |
| 263 |
| 0 |
| 263 |
| 0 |
| 263 |
| EG001 | Brochure Wait List | Brochure wait list control group Brochure: Brochure on the Female athlete triad | 0 | 218 | 0 | 218 | 0 | 218 |
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| D000080822 | Relative Energy Deficiency in Sport |
| Ideal-Body Stereotype Scale - Revised (IBSSR) |
|
| Positive and Negative Affect Scale - Revised |
|
| Intervention Suitability Expectations (ISE) |
|
| Knowledge of the Female Athlete Triad |
|