Effectiveness of BIM in Reducing Disordered Eating Among Student AthletesPhase 3NCT05864287
Pac-12 Test of the Effectiveness of Bodies in Motion in Reducing Disordered Eating and Body Image Concerns
A Phase 3 study testing Bodies in motion intervention program in people with Effectiveness of BIM in Reducing Disordered Eating Among Student Athletes and Effectiveness of BIM in Reducing Body Image Concerns Among Student Athletes, run by University of Arizona at 1 site in United States.
Trial summary
In the proposed study, the investigators will examine the effectiveness of Bodie in Motion (BIM) program in improving the body image, eating concerns, and overall psychological well-being, in a racially/ethnically diverse group of female and male-identifying athletes with body image concerns. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Effectiveness of BIM in Reducing Disordered Eating Among Student Athletes, Effectiveness of BIM in Reducing Body Image Concerns Among Student Athletes, Effectiveness of BIM Improving Psychological Well-Being Among Student Athletes
- What is being tested?
- Bodies in motion intervention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 8 Aug 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Current student-athlete
- At least 18 years of age at a Pac-12 University
- Fluently read, write, and speak English.
Who cannot join
- Unwilling to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pac-12 Test of the Effectiveness of Bodies in Motion in Reducing Disordered Eating and Body Image Concerns, and Improving Psychological Well-Being, Among Male and Female Student-Athletes
In the proposed study, the investigators will examine the effectiveness of Bodie in Motion (BIM) program in improving the body image, eating concerns, and overall psychological well-being, in a racially/ethnically diverse group of female and male-identifying athletes with body image concerns. Based on previous research, participating athletes should have direct and immediate Well-Being (i.e., mental health) benefits from their involvement in BIM.
Read the detailed description
The Primary Aim of this project is to modify (based on diverse college student athlete acceptability and effectiveness feedback) and then further test the effectiveness of the evidence-based Bodies in Motion (BIM) program in reducing the body image concerns, decreasing the disordered eating symptoms, and improving the psychological well-being (e.g., depression, anxiety) in a racially/ethnically diverse group of female and male-identifying student-athletes in the Pac-12 conference.
The primary hypothesis is that, compared to treatment as usual (TAU) control athletes who have been matched on race, ethnicity, sport, and gender (male vs. female-identifying), athletes completing the BIM treatment will have greater improvements on body image and eating concerns, and lower levels of depression and anxiety. These differences will occur immediately following completion of BIM and will be maintained at 6- and 12-months. In keeping with our mixed-methods approach, through qualitative interviews conducted with the athletes who have participated in the BIM program, the investigators will explore their perceptions of the program's efficacy, relative to how the awareness, perspectives, and skills developed from the program have, or have not, informed their relationship with themselves, their bodies, food, physical activity, and general psychological well-being. The investigators expect that, based on past research (Voelker, Petrie et al., 2021) that athletes will report increased awareness of self and body, positive shifts in how they view themselves and their bodies, and the adoption of psychological tools (e.g., mindful self-compassion) to cope more effectively with appearance stressors.
The secondary Aim is to determine if the BIM program's effectiveness differs based on athletes' race/ ethnicity within each gender (e.g., for female-identifying athletes). That is, does athlete race/ethnicity moderate their BIM outcomes.
Exploratory aims include examining if sport played and facilitators' professional training (e.g., sport nutritionist, sport psychologist) further moderate outcomes.
Student athletes will be recruited through self-selection into the Bodies in Motion (BIM) program from one of the seven participating schools who will be offering this treatment. Athletes who A) self-identify as experiencing body image concerns, or B) are referred by someone (e.g., nutritionist, athletic trainer) based on some expressed body dissatisfaction. Each university intervention site will offer BIM to its athletes as a clinical service. And upon enrolling in BIM, athletes will be presented with an overview of the ongoing research study and the opportunity to provide consent for their intervention data to be shared for research purposes. Consent to sharing data for research purposes will not be required for participating in BIM. Athletes participating in BIM who give consent to share their data for research purposes (via electronic consent documentation) will complete additional surveys related to treatment outcomes.
Once the investigators have the BIM intervention participants identified and consented into the study, the investigators will then go into the MH-CDE screener data to find "matched" participants at other schools.
Matched-control participants will already be completing the Mental Health Common Data Elements (MH-CDEs) as part of their biannual mental health screeners in their respective athletics department. As part of their clinical care within the various athletic departments, student-athletes are asked to complete a variety of assessments (e.g., physical, MH-CDEs, etc.). The MH-CDEs are currently delivered via REDCap through a link provided in email. For the matched-control participants, the investigators will have a consent at the end of the MH-CDEs explaining the study and asking if the investigators can utilize their data for research purposes. The investigators will make it clear that participating in our study (i.e., allowing us to use their data) in no way affects their ability to participate in sports.
- Conditions
- Effectiveness of BIM in Reducing Disordered Eating Among Student Athletes, Effectiveness of BIM in Reducing Body Image Concerns Among Student Athletes, Effectiveness of BIM Improving Psychological Well-Being Among Student Athletes
- Being tested
- Bodies in motion intervention program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bodies in motion intervention programBehavioural
Intervention groups will be offered separately to male- and female-identifying athletes; each group will consist of six to eight athletes and multiple groups may be run each academic term. Facilitators will use the gender-specific programs in their delivery. Intervention athletes will receive a participant workbook as well as be invited to join a BIM-specific, private social media platform that will allow them to share, connect, and support each other through out their involvement in the program. As part of our mixed-methods design, we will also conduct qualitative interviews to explore the student athletes' experiences of the BIM program. Following intervention, we will invite 12-16 male and 12-16 female identifying athletes who completed the BIM program to participate in the structured interviews. Interviews will be semi-structured and are expected to last 60-90 minutes
| Study group | Role | What they receive |
|---|---|---|
| BIM intervention participants | Other | Specifically, at each of the seven intervention sites, a minimum of 30 male and 30 female-identifying student athletes will participate in the BIM program across the 2022-2023 academic year. Thus, our intervention sample will be a minimum of 210 male and 210 female identifying intervention group athletes. The BIM program is a manualized intervention that consists of a 35-min introductory session, followed by four, 75-min sessions. Athletes participating in BIM who give consent (via electronic consent documentation) to share their de-identified data for research purposes will complete additional surveys beyond the standard MH-CDE set of baseline measures at one time-point and treatment-related measures at five time-points:
* Pre-intervention/Baseline
* Post-intervention (1-2 weeks after)
* 4-months post-intervention
* 12-months post-intervention Receives: Behavioral: Bodies in motion intervention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change between baseline and post intervention Weight Pressures in Sport (WPS) Scale
Self-reported weight loss pressures from the external environment.
Measured: pre-intervention, 1-2 weeks, 4 months and 12 months post intervention
Change between baseline and post intervention Sociocultural Attitudes Toward Appearance Questionnaire-4 (SATAQ-4
Self-reported thinness and muscularity internalization.
Measured: pre-intervention, 1-2 weeks, 4 months and 12 months post intervention
Change between baseline and post intervention Sociocultural Attitudes Toward Appearance Questionnaire
Self-reported weight loss, thinness and muscularity perceived from outside pressures.
Measured: pre-intervention, 1-2 weeks, 4 months and 12 months post intervention
Change between baseline and post intervention Body Parts Satisfaction Scale-Revised (BPSS-R)
Self-reported body part satisfaction
Measured: pre-intervention, 1-2 weeks, 4 months and 12 months post intervention
Change between baseline and post intervention Self-Compassion Scale - Short Form (SCS-SF)
Self-reported frequency of self-compassionate attitudes and behaviors.
Measured: pre-intervention, 1-2 weeks, 4 months and 12 months post intervention
Secondary outcomes (3)
Patient Health Questionnaire-2 Item (PHQ-2
Self-reported frequency of depressed mood and anhedonia.
Measured: Baseline
Generalized Anxiety Disorder-2 Item (GAD-2)
Self-reported severity of frequency of nervous/anxious/on edge/worry behaviors.
Measured: Baseline
Eating Disorder Examination Questionnaire-Short Form (EDE-QS)
Self-reported eating disorder symptoms.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 Sep 2022
- Primary completion8 Aug 2024
- Study completion8 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effectiveness of BIM in Reducing Disordered Eating Among Student AthletesStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- No treatment control
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Texas Health Science Center
- Responsible party
- Sponsor
- Investigators
- Daniel Taylor, Ph.D, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864287
- Sponsor's protocol ID
- STUDY00000865
- Status last verified
- Aug 2024
- First submitted
- 30 Sep 2022
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pac-12 Test of the Effectiveness of Bodies in Motion in Reducing Disordered Eating and Body Image Concerns, and Improving Psychological Well-Being, Among Male and Female Student-Athletes
- ClinicalTrials.gov ID
- NCT05864287
- Acronym / sponsor ID
- STUDY00000865
- Conditions
- Effectiveness of BIM in Reducing Disordered Eating Among Student Athletes, Effectiveness of BIM in Reducing Body Image Concerns Among Student Athletes, Effectiveness of BIM Improving Psychological Well-Being Among Student Athletes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- University of North Texas Health Science Center
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the proposed study, the investigators will examine the effectiveness of Bodie in Motion (BIM) program in improving the body image, eating concerns, and overall psychological well-being, in a racially/ethnically diverse group of female and male-identifying athletes with body image concerns. Based on previous research, participating athletes should have direct and immediate Well-Being (i.e., mental health) benefits from their involvement in BIM.
Detailed description
The Primary Aim of this project is to modify (based on diverse college student athlete acceptability and effectiveness feedback) and then further test the effectiveness of the evidence-based Bodies in Motion (BIM) program in reducing the body image concerns, decreasing the disordered eating symptoms, and improving the psychological well-being (e.g., depression, anxiety) in a racially/ethnically diverse group of female and male-identifying student-athletes in the Pac-12 conference.
The primary hypothesis is that, compared to treatment as usual (TAU) control athletes who have been matched on race, ethnicity, sport, and gender (male vs. female-identifying), athletes completing the BIM treatment will have greater improvements on body image and eating concerns, and lower levels of depression and anxiety. These differences will occur immediately following completion of BIM and will be maintained at 6- and 12-months. In keeping with our mixed-methods approach, through qualitative interviews conducted with the athletes who have participated in the BIM program, the investigators will explore their perceptions of the program's efficacy, relative to how the awareness, perspectives, and skills developed from the program have, or have not, informed their relationship with themselves, their bodies, food, physical activity, and general psychological well-being. The investigators expect that, based on past research (Voelker, Petrie et al., 2021) that athletes will report increased awareness of self and body, positive shifts in how they view themselves and their bodies, and the adoption of psychological tools (e.g., mindful self-compassion) to cope more effectively with appearance stressors.
The secondary Aim is to determine if the BIM program's effectiveness differs based on athletes' race/ ethnicity within each gender (e.g., for female-identifying athletes). That is, does athlete race/ethnicity moderate their BIM outcomes.
Exploratory aims include examining if sport played and facilitators' professional training (e.g., sport nutritionist, sport psychologist) further moderate outcomes.
Student athletes will be recruited through self-selection into the Bodies in Motion (BIM) program from one of the seven participating schools who will be offering this treatment. Athletes who A) self-identify as experiencing body image concerns, or B) are referred by someone (e.g., nutritionist, athletic trainer) based on some expressed body dissatisfaction. Each university intervention site will offer BIM to its athletes as a clinical service. And upon enrolling in BIM, athletes will be presented with an overview of the ongoing research study and the opportunity to provide consent for their intervention data to be shared for research purposes. Consent to sharing data for research purposes will not be required for participating in BIM. Athletes participating in BIM who give consent to share their data for research purposes (via electronic consent documentation) will complete additional surveys related to treatment outcomes.
Once the investigators have the BIM intervention participants identified and consented into the study, the investigators will then go into the MH-CDE screener data to find "matched" participants at other schools.
Matched-control participants will already be completing the Mental Health Common Data Elements (MH-CDEs) as part of their biannual mental health screeners in their respective athletics department. As part of their clinical care within the various athletic departments, student-athletes are asked to complete a variety of assessments (e.g., physical, MH-CDEs, etc.). The MH-CDEs are currently delivered via REDCap through a link provided in email. For the matched-control participants, the investigators will have a consent at the end of the MH-CDEs explaining the study and asking if the investigators can utilize their data for research purposes. The investigators will make it clear that participating in our study (i.e., allowing us to use their data) in no way affects their ability to participate in sports.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- No treatment control
| Arm | Type | Receives |
|---|---|---|
| BIM intervention participants | Other | Behavioral: Bodies in motion intervention programSpecifically, at each of the seven intervention sites, a minimum of 30 male and 30 female-identifying student athletes will participate in the BIM program across the 2022-2023 academic year. Thus, our intervention sample will be a minimum of 210 male and 210 female identifying intervention group athletes. The BIM program is a manualized intervention that consists of a 35-min introductory session, followed by four, 75-min sessions. Athletes participating in BIM who give consent (via electronic consent documentation) to share their de-identified data for research purposes will complete additional surveys beyond the standard MH-CDE set of baseline measures at one time-point and treatment-related measures at five time-points: * Pre-intervention/Baseline * Post-intervention (1-2 weeks after) * 4-months post-intervention * 12-months post-intervention |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Current student-athlete
- At least 18 years of age at a Pac-12 University
- Fluently read, write, and speak English.
Key exclusion criteria (1 listed)
- Unwilling to provide informed consent.
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 |
|---|---|---|
| Bodies in motion intervention programIntervention groups will be offered separately to male- and female-identifying athletes; each group will consist of six to eight athletes and multiple groups may be run each academic term. Facilitators will use the gender-specific programs in their delivery. Intervention athletes will receive a participant workbook as well as be invited to join a BIM-specific, private social media platform that will allow them to share, connect, and support each other through out their involvement in the program. As part of our mixed-methods design, we will also conduct qualitative interviews to explore the student athletes' experiences of the BIM program. Following intervention, we will invite 12-16 male and 12-16 female identifying athletes who completed the BIM program to participate in the structured interviews. Interviews will be semi-structured and are expected to last 60-90 minutes | Behavioural | BIM intervention participants |
Primary outcome
Change between baseline and post intervention Weight Pressures in Sport (WPS) Scale
Time frame: pre-intervention, 1-2 weeks, 4 months and 12 months post intervention
Self-reported weight loss pressures from the external environment.
Change between baseline and post intervention Sociocultural Attitudes Toward Appearance Questionnaire-4 (SATAQ-4
Time frame: pre-intervention, 1-2 weeks, 4 months and 12 months post intervention
Self-reported thinness and muscularity internalization.
Change between baseline and post intervention Sociocultural Attitudes Toward Appearance Questionnaire
Time frame: pre-intervention, 1-2 weeks, 4 months and 12 months post intervention
Self-reported weight loss, thinness and muscularity perceived from outside pressures.
Change between baseline and post intervention Body Parts Satisfaction Scale-Revised (BPSS-R)
Time frame: pre-intervention, 1-2 weeks, 4 months and 12 months post intervention
Self-reported body part satisfaction
Change between baseline and post intervention Self-Compassion Scale - Short Form (SCS-SF)
Time frame: pre-intervention, 1-2 weeks, 4 months and 12 months post intervention
Self-reported frequency of self-compassionate attitudes and behaviors.
3 secondary outcomes
Patient Health Questionnaire-2 Item (PHQ-2
Time frame: Baseline
Generalized Anxiety Disorder-2 Item (GAD-2)
Time frame: Baseline
Eating Disorder Examination Questionnaire-Short Form (EDE-QS)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: No
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.
Daniel Taylor, Ph.D principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bodies in motion intervention program in people with Effectiveness of BIM in Reducing Disordered Eating Among Student Athletes and Effectiveness of BIM in Reducing Body Image Concerns Among Student Athletes, run by University of Arizona 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 15 Apr 2025. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change between baseline and post intervention Weight Pressures in Sport (WPS) Scale (time frame: pre-intervention, 1-2 weeks, 4 months and 12 months post intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2025.