Body ImageNCT05222360
Improvement of Body Image Flexibility in High School Female Athletes Doing Educational About Nutrition and Body Image
An observational study of Body Image and Nutrition, Healthy, run by Rocky Mountain Sports Medicine at 1 site in United States.
Trial summary
Evaluation of increase in body flexibility in female high school athletes undergoing education on nutrition and body image Read more about this study
- Who is it for?
- Ages 14 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Image, Nutrition, Healthy
- What is being tested?
- Education
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 13 Jan 2022
- Phase
- Observational
- 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 14 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: These are athletes at local high schools who identify as female. The demographic area is primarily socioeconomically middle class.
Who may be able to join
- identify as female
- athlete at local high school
- willing to fill out survey at beginning and end of sessions
- willing to provide consent
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Sports Medicine
Parker, Colorado, 80134
About this study
Official title: Improvement of Body Image Flexibility in High School Female Athletes Undergoing Three Educational Sessions About Nutrition and Body Image
Evaluation of increase in body flexibility in female high school athletes undergoing education on nutrition and body image
Read the 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.
- Conditions
- Body Image, Nutrition, Healthy
- Being tested
- Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
3 educational sessions about body image and nutrition
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
BI-AAQ Scores
scores on body image flexibility
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 Aug 2020
- Primary completion13 Jan 2022
- Study completion13 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body ImageStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rocky Mountain Sports Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathryn Vidlock, M.D., Principal investigator, Rocky Mountain Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222360
- Sponsor's protocol ID
- 52345
- Status last verified
- Feb 2022
- First submitted
- 23 Jan 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have yet to find a place that shares BI-AAQ data as it is a unique questionaire
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Body Image Flexibility in High School Female Athletes Undergoing Three Educational Sessions About Nutrition and Body Image
- ClinicalTrials.gov ID
- NCT05222360
- Acronym / sponsor ID
- 52345
- Conditions
- Body Image, Nutrition, Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Rocky Mountain Sports MedicineUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 13 Jan 2022 (actual)
- Study completion
- 13 Jan 2022 (actual)
- First posted
- 3 Feb 2022 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| female high school athletes | – | Other: EducationAthletes 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 |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- These are athletes at local high schools who identify as female. The demographic area is primarily socioeconomically middle class.
Key inclusion criteria (4 listed)
- identify as female
- athlete at local high school
- willing to fill out survey at beginning and end of sessions
- willing to provide consent
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 |
|---|---|---|
| Education3 educational sessions about body image and nutrition | Other | female high school athletes |
Primary outcome
BI-AAQ Scores
Time frame: 2 months
scores on body image flexibility
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 18 Feb 2022.
- Individual participant dataSharing planned: Undecided. We have yet to find a place that shares BI-AAQ data as it is a unique questionaire
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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.
Kathryn Vidlock, M.D. principal investigator
Rocky Mountain Sports Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Image and Nutrition, Healthy, run by Rocky Mountain Sports Medicine 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 4 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 18 Feb 2022. 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?
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?
BI-AAQ Scores (time frame: 2 months). 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 18 Feb 2022.