Improvement of Body Image Flexibility in High School Fema... | NCT05222360

Studies
Improvement of Body Image Flexibility in High School Female Athletes Doing Educational About Nutrition and Body Image

NCT05222360

Sponsor

Rocky Mountain Sports Medicine

Status

Completed

Last Update Posted

Feb 18, 2022Actual

Enrollment

49Actual

Phase

Not provided

Conditions

Body Image
Nutrition, Healthy

Interventions

Education

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2020Actual

Primary Completion Date

Jan 13, 2022Actual

Completion Date

Jan 13, 2022Actual

First Submitted Date

Jan 23, 2022

First Submission Date that Met QC Criteria

Jan 23, 2022

First Posted Date

Feb 3, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2022

Last Update Posted Date

Feb 18, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluation of increase in body flexibility in female high school athletes undergoing education on nutrition and body image

Detailed Description

This study was a prospective cohort design. Female high school athletes were asked to participate in three educational sessions about nutrition, body image flexibility, and RED-S (relative energy deficiency in sport). Pre and post-tests were done with a validated tool measuring body image flexibility.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
female high school athletes		Athletes who identify as female at a local high school who are in an athletic program. There was no control group as the school wanted everyone to have the 3 educational sessions. The athletes underwent 3 educational sessions. No medication was used. Education was the intervention	Other: Education

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Education	Other	3 educational sessions about body image and nutrition	female high school athletes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
BI-AAQ Scores	scores on body image flexibility	2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

identify as female
athlete at local high school
willing to fill out survey at beginning and end of sessions
willing to provide consent

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

identify as female

Minimum Age

14 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

These are athletes at local high schools who identify as female. The demographic area is primarily socioeconomically middle class.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kathryn Vidlock, M.D.	Rocky Mountain Sports Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rocky Mountain Sports Medicine		Parker	Colorado	80134	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

We have yet to find a place that shares BI-AAQ data as it is a unique questionaire

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004522	Educational Status

Ancestor Terms

ID	Term
D012959	Socioeconomic Factors
D011154	Population Characteristics

Browse Leaves

Not provided

Browse Branches

Not provided