Eating DisordersFABNCT01735994
Efficacy of the Female Athlete Body Project (FAB)
A study testing Healthy Weight and Brochure in people with Eating Disorders and Female Athlete Triad, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders, Female Athlete Triad
- What is being tested?
- Healthy Weight and Brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 481 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Healthy Weight Intervention in Female Athletes: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Eating Disorders, Female Athlete Triad
- Being tested
- Healthy Weight, Brochure
- Keywords
- Eating disorders, body image, female athletes, female athlete triad, eating disorder prevention, cluster randomization, risk factors, prevention
- Medical subject headings
- Feeding and Eating Disorders, Female Athlete Triad Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy WeightBehavioural
Eating Disorder Prevention Program for Athletes
BrochureOther
Brochure on the Female athlete triad
| Study group | Role | What they receive |
|---|---|---|
| Healthy Weight Intervention | Experimental | Eating Disorder Prevention Program Receives: Behavioral: Healthy Weight |
| Brochure wait list | Other | Brochure wait list control group Receives: Other: Brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 18 months
Secondary outcomes (2)
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).
Measured: 18 months
Secondary Outcomes - BMI
Body Mass Index (BMI) (self-reported) is a measure of kg/m^2.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 481 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Tiffany Stewart, Pennington Biomedical Research Center
- Investigators
- Tiffany M Stewart, PhD, Principal investigator, Pennington Biomedical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735994
- Sponsor's protocol ID
- PBRC 11032
- Other IDs
- R01MH094448
- Acronym
- FAB
- Status last verified
- Nov 2019
- First submitted
- 14 Nov 2012
- Last updated
- 4 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28611008Stewart 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.
PubMed 31350934Stewart 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.
PubMed 33952348
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Weight Intervention in Female Athletes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01735994
- Acronym / sponsor ID
- FAB / PBRC 11032
- Conditions
- Eating Disorders, Female Athlete Triad
- Keywords
- Eating disorders, body image, female athletes, female athlete triad, eating disorder prevention, cluster randomization, risk factors, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 481 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2012
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 28 Nov 2012 (estimated)
- Results
- Posted 4 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Weight Intervention | Experimental | Behavioral: Healthy WeightEating Disorder Prevention Program |
| Brochure wait list | Other | Other: BrochureBrochure wait list control group |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy WeightEating Disorder Prevention Program for Athletes | Behavioural | Healthy Weight Intervention |
| BrochureBrochure on the Female athlete triad | Other | Brochure wait list |
Primary outcome
Eating Disorder Examination Questionnaire (EDE-Q)
Time frame: 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)
Time frame: 18 months
Frequency of subjective and objective binge episodes is reported.
2 secondary outcomes
Secondary Outcomes
Time frame: 18 months
Secondary Outcomes - BMI
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28611008Stewart 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.
- Background: PubMed 31350934Stewart 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.
- Derived from this study: PubMed 33952348Stewart 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiffany M Stewart, PhD principal investigator
Pennington Biomedical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Weight and Brochure in people with Eating Disorders and Female Athlete Triad, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Disorder Examination Questionnaire (EDE-Q) (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01735994, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2019.