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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
95

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Israel
    • North Of Israel
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Clinical intervention program to prevent eating disorders
See previous
NO_INTERVENTION: Control Group
No participation in intervention program.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tel Hai College

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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