An interventional study of Healthy Weight and Brochure in Eating Disorders and Female Athlete Triad, sponsored by Pennington Biomedical Research Center. Completed at 1 site in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-04.
Sponsored by Pennington Biomedical Research Center · Not applicable, Interventional, and Prevention
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.
740 studies on the registry are indexed under Feeding and Eating Disorders; 159 are open to participants now.
This study's enrollment of 481 is above the median of 75 across 540 interventional studies indexed under Feeding and Eating Disorders.
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Exclusion Criteria:
Eating Disorder Prevention Program
Behavioral: Healthy Weight
Brochure wait list control group
Other: Brochure
Eating Disorder Prevention Program for Athletes
Brochure on the Female athlete triad
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
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
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
Secondary Outcomes - BMI
Body Mass Index (BMI) (self-reported) is a measure of kg/m\^2.
Time frame: 18 months
Study enrollment began at the schools in August 2012 and completed in October 2014.
| Milestone | Healthy Weight Intervention | Brochure Wait List |
|---|---|---|
| Started | 263 | 218 |
| Post intervention (3 weeks) | 239 | 198 |
| Follow-up #1 (6 months) | 213 | 163 |
| Follow-up #2 (12 months) | 212 | 174 |
| Completed | 200 | 152 |
| Not completed | 63 | 66 |
| Withdrew: Withdrawal by subject | 6 | 4 |
| Withdrew: Injury | 2 | 0 |
| Withdrew: Kicked off team | 5 | 0 |
| Withdrew: Lost to follow-up | 50 | 62 |
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.
| units on a scale | Healthy Weight Intervention | Brochure Wait List |
|---|---|---|
| Global | .98 ± .17 | 1.24 ± .16 |
| Restraint | .54 ± .11 | .84 ± .18 |
| Shape Concern | 1.13 ± .21 | 1.46 ± .28 |
| Weight Concern | 1.03 ± .26 | 1.17 ± .24 |
| Eating Concern | .49 ± .16 | .55 ± .15 |
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).
| score on a scale | Healthy Weight Intervention | Brochure Wait List |
|---|---|---|
| Internalization of the Sport-Specific Thin-Ideal | 2.46 ± .18 | 2.71 ± .31 |
| Teammate Relationship Health (TRH) | 30.28 ± .65 | 29.87 ± .85 |
| Ideal-Body Stereotype Scale - Revised (IBSSR) | 3.20 ± .06 | 3.43 ± .05 |
| Positive and Negative Affect Scale - Revised | 1.50 ± .04 | 1.59 ± .06 |
| Intervention Suitability Expectations (ISE) | 29.92 ± 7.80 | 26.50 ± 8.52 |
| Knowledge of the Female Athlete Triad | 8.54 ± .37 | 8.58 ± .30 |
Frequency of subjective and objective binge episodes is reported.
| episodes | Healthy Weight Intervention | Brochure Wait List |
|---|---|---|
| Objective Binge Episode Frequency | .35 ± 1.56 | .63 ± 1.75 |
| Subjective Binge Episode Frequency | .49 ± 1.94 | .57 ± 3.52 |
Body Mass Index (BMI) (self-reported) is a measure of kg/m\^2.
| kg/m^2 | Healthy Weight Intervention | Brochure Wait List |
|---|---|---|
| Secondary Outcomes - BMI | 25.09 ± 1.12 | 24.22 ± .90 |
Collected over Adverse event data was collected over a period of 18 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Weight Intervention | 0/263 (0%) | 0/263 (0%) | 0/263 (0%) |
| Brochure Wait List | 0/218 (0%) | 0/218 (0%) | 0/218 (0%) |
| Age, Continuous(years) | Healthy Weight Intervention | Brochure Wait List | Total |
|---|---|---|---|
| Mean | 19.29 ± 1.25 | 19.42 ± 1.18 | 19.35 ± 1.22 |
| Sex: Female, Male(Participants) | Healthy Weight Intervention | Brochure Wait List | Total |
|---|---|---|---|
| Female | 263 | 218 | 481 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Healthy Weight Intervention | Brochure Wait List | Total |
|---|---|---|---|
| Hispanic or Latino | 37 | 27 | 64 |
| Not Hispanic or Latino | 205 | 183 | 388 |
| Unknown or Not Reported | 21 | 8 | 29 |
| Race (NIH/OMB)(Participants) | Healthy Weight Intervention | Brochure Wait List | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 3 | 5 |
| Asian | 7 | 2 | 9 |
| Native Hawaiian or Other Pacific Islander | 3 | 3 | 6 |
| Black or African American | 43 | 28 | 71 |
| White | 193 | 171 | 364 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 15 | 11 | 26 |
| Height (inches)(inches) | Healthy Weight Intervention | Brochure Wait List | Total |
|---|---|---|---|
| Mean | 65.95 ± 3.39 | 66.18 ± 4.00 | 66.05 ± 3.68 |
| Weight (pounds)(pounds) | Healthy Weight Intervention | Brochure Wait List | Total |
|---|---|---|---|
| Mean | 140.80 ± 22.47 | 138.80 ± 23.72 | 139.90 ± 23.04 |
| BMI(kg/m^2) | Healthy Weight Intervention | Brochure Wait List | Total |
|---|---|---|---|
| Mean | 22.74 ± 3.01 | 22.23 ± 2.65 | 22.50 ± 2.86 |
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Pennington Biomedical Research Center