- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05864287
Pac-12 Bodies in Motion
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Talani Bertram
- Phone Number: 520-621-8366
- Email: tbertra@arizona.edu
Study Contact Backup
- Name: Sarah Emert, Ph.D
- Phone Number: 520-6218366
- Email: semert@arizona.edu
Study Locations
-
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Arizona
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Tucson, Arizona, United States, 85712
- Recruiting
- The University of Arizona
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Principal Investigator:
- Daniel J Taylor, Ph.D.
-
Contact:
- Talani Bertram
- Phone Number: 520-621-8366
- Email: tbertra@arizona.edu
-
Contact:
- Sarah Emert, Ph.D.
- Phone Number: 520-621-8366
- Email: semert@arizona.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Current student-athlete
- At least 18 years of age at a Pac-12 University
- Fluently read, write, and speak English.
Exclusion Criteria:
• Unwilling to provide informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: BIM intervention participants
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:
|
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
Time Frame: pre-intervention, 1-2 weeks, 4 months and 12 months post intervention
|
Self-reported thinness and muscularity internalization.
|
pre-intervention, 1-2 weeks, 4 months and 12 months post intervention
|
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.
|
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)
Time Frame: pre-intervention, 1-2 weeks, 4 months and 12 months post intervention
|
Self-reported body part satisfaction
|
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)
Time Frame: pre-intervention, 1-2 weeks, 4 months and 12 months post intervention
|
Self-reported frequency of self-compassionate attitudes and behaviors.
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pre-intervention, 1-2 weeks, 4 months and 12 months post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Health Questionnaire-2 Item (PHQ-2
Time Frame: Baseline
|
Self-reported frequency of depressed mood and anhedonia.
|
Baseline
|
Generalized Anxiety Disorder-2 Item (GAD-2)
Time Frame: Baseline
|
Self-reported severity of frequency of nervous/anxious/on edge/worry behaviors.
|
Baseline
|
Eating Disorder Examination Questionnaire-Short Form (EDE-QS)
Time Frame: Baseline
|
Self-reported eating disorder symptoms.
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Daniel Taylor, Ph.D, University of Arizona
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00000865
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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