- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03211468
Intervention Program to Improve Body Image and Self-Esteem Among Female Athletes.
July 5, 2018 updated by: Tel Hai College
Effectiveness of an Intervention Program to Improve Body Image and Self-Esteem Among Female Adolescent Aesthetic Athletes.
A controlled, randomized clinical intervention study which includes the development and activation of an intervention program designed to prevent eating disorders among adolescent female aesthetic athletes.
Our hypothesis is that the intervention program will yield improvement in the participants' eating behaviors, drive for thinness, and body image as compared with the age matched control group.
Results will be measured using the study questionnaire, to be filled out by the participants before, after, and three months after the completion of the program.
The Questionnaire will include validated questionnaires with good psychometric qualities.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Eating disorders can cause a decrease in athletic performance and affect the overall health of athletes.
Athletes are exposed to an increased risk of developing pathological eating behaviors and dissatisfaction with their bodies.
A number of studies have found higher rates of eating pathologies in aesthetic sports such as dance, ice skating, and gymnastics.
Other studies have found that intervention programs designed to prevent eating disorders in athletes have yielded promising results.
The current study will examine the effects of a controlled clinical intervention program designed to prevent eating disorders and improve the body image of female adolescent figure skaters and dancers.
The program will consist of ten 45-minute interactive sessions led by the researcher.
Each session will include a brief theoretical background, experiential activities (artistic or cognitive / emotional) and group discussions.
The control group shall include age matched athletes who will not participate in the intervention program.
The impact of the intervention shall be assessed with a nonrandomized, controlled experimental group design.
To assess the impact and outcome of the intervention, all participants in the research and control groups will be asked to complete the study questionnaire at pre, post, and 3-month (after post) follow-up assessments.
Process evaluation, which assesses program dissemination, attendance and relapse rates, as well as assessment of participants' satisfaction, will be performed at the end of the program.
The study questionnaire includes: Personal and Demographic Information, EDI-2 (Eating Disorders Inventory), Body Esteem Scale-Mendelson, SATAQ-4 (Sociocultural Attitudes Towards Appearance Questionnaire-4), EDE-Q 8 (Eating Disorder Examination Questionnaire- 8), BAS (Body Appreciation Scale).
All questionnaires have good psychometric properties.
The study hypothesis is that the intervention program will result in improvement in the intervention group in terms of: disturbed eating behaviors, pursuit of thinness, body-dissatisfaction and external influences on body image compared with an age-matched control group that did not participate in the program.
Study Type
Interventional
Enrollment (Actual)
95
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Of Israel
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Kiryat Shmona, North Of Israel, Israel, 1220800
- Academic College of Tel Hai
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 16 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female
- Age 10-16
- Athletes in aesthetic sports: figure skaters, dancers and gymnasts.
Exclusion Criteria:
- Males
- Females under age 10 or over 16
- Athletes from non-aesthetic sports
- Non-athletes.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Intervention Program
Clinical intervention designed to prevent eating disorders and promote healthy eating habits and body image among female adolescent athletes.
The intervention program will include 10 45-min interactive sessions led by the researcher.
Each session will include a brief theoretical background, experiential activities (artistic or cognitive / emotional) and group discussions.
|
See previous
|
|
NO_INTERVENTION: Control Group
No participation in intervention program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in results of study questionnaire.
Time Frame: Each participant shall be assessed for a total duration of 6 months.
|
Questionnaire shall be answered by study participants by hand or using Qualtrics online software.
3 points of assessment for each participant: baseline, post-intervention, and 3 months follow-up.
|
Each participant shall be assessed for a total duration of 6 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2017
Primary Completion (ACTUAL)
April 1, 2018
Study Completion (ACTUAL)
June 1, 2018
Study Registration Dates
First Submitted
May 7, 2017
First Submitted That Met QC Criteria
July 5, 2017
First Posted (ACTUAL)
July 7, 2017
Study Record Updates
Last Update Posted (ACTUAL)
July 9, 2018
Last Update Submitted That Met QC Criteria
July 5, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tel Hai College
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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