NCT05864287

Brief 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. Based on previous research, participating athletes should have direct and immediate Well-Being (i.e., mental health) benefits from their involvement in BIM.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2022

Completed
8 months until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2024

Completed
Last Updated

April 15, 2025

Status Verified

August 1, 2024

Enrollment Period

1.9 years

First QC Date

September 30, 2022

Last Update Submit

April 10, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Change between baseline and post intervention Weight Pressures in Sport (WPS) Scale

    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

    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

    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)

    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)

    Self-reported frequency of self-compassionate attitudes and behaviors.

    pre-intervention, 1-2 weeks, 4 months and 12 months post intervention

Secondary Outcomes (3)

  • Patient Health Questionnaire-2 Item (PHQ-2

    Baseline

  • Generalized Anxiety Disorder-2 Item (GAD-2)

    Baseline

  • Eating Disorder Examination Questionnaire-Short Form (EDE-QS)

    Baseline

Study Arms (1)

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

Behavioral: Bodies in motion intervention program

Interventions

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

BIM intervention participants

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Current student-athlete
  • At least 18 years of age at a Pac-12 University
  • Fluently read, write, and speak English.

You may not qualify if:

  • Unwilling to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The university of Arizona

Tucson, Arizona, 85712, United States

Location

Study Officials

  • Daniel Taylor, Ph.D

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Masking Details
This is an open trial of Bodies In Motion (BIM) Intervention. The study will primarily examine results pre-post treatment within these athletes. However, athletes who do not sign up to participate in the BIM may be used as "no treatment controls", utilizing data collected during their bi-annual mental health screens and propensity matching. However, this does not typically qualify as an "Arm".
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: No treatment control
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2022

First Posted

May 18, 2023

Study Start

September 1, 2022

Primary Completion

August 8, 2024

Study Completion

August 8, 2024

Last Updated

April 15, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations