Feeding and Eating DisordersNCT03211468
Intervention Program to Improve Body Image and Self-Esteem Among Female Athletes.
A study testing Clinical intervention program to prevent eating disorders in people with Feeding and Eating Disorders, run by Tel Hai College at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 16 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Feeding and Eating Disorders
- What is being tested?
- Clinical intervention program to prevent eating disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2017to 1 Jun 2018
- Phase
- Interventional
- 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 10 to 16 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Female
- Age 10-16
- Athletes in aesthetic sports: figure skaters, dancers and gymnasts.
Who cannot join
- Males
- Females under age 10 or over 16
- Athletes from non-aesthetic sports
- Non-athletes.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Academic College of Tel Hai
Kiryat Shmona, North of Israel, 1220800
About this study
Official title: 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.
Read the 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.
- Conditions
- Feeding and Eating Disorders
- Being tested
- Clinical intervention program to prevent eating disorders
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical intervention program to prevent eating disordersBehavioural
See previous
| Study group | Role | What they receive |
|---|---|---|
| Intervention Program | Experimental | 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. Receives: Behavioral: Clinical intervention program to prevent eating disorders |
| Control Group | No intervention | No participation in intervention program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in results of study questionnaire.
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.
Measured: Each participant shall be assessed for a total duration of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start1 May 2017
- Primary completion1 Apr 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding and Eating DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Hai College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211468
- Sponsor's protocol ID
- Tel Hai College
- Status last verified
- Jul 2018
- First submitted
- 7 May 2017
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Intervention Program to Improve Body Image and Self-Esteem Among Female Adolescent Aesthetic Athletes.
- ClinicalTrials.gov ID
- NCT03211468
- Acronym / sponsor ID
- Tel Hai College
- Conditions
- Feeding and Eating Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Tel Hai CollegeUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 7 Jul 2017 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Program | Experimental | Behavioral: Clinical intervention program to prevent eating disordersClinical 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. |
| Control Group | No intervention | –No participation in intervention program. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Female
- Age 10-16
- Athletes in aesthetic sports: figure skaters, dancers and gymnasts.
Key exclusion criteria (4 listed)
- Males
- Females under age 10 or over 16
- Athletes from non-aesthetic sports
- Non-athletes.
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 |
|---|---|---|
| Clinical intervention program to prevent eating disordersSee previous | Behavioural | Intervention Program |
Primary outcome
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.
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 9 Jul 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical intervention program to prevent eating disorders in people with Feeding and Eating Disorders, run by Tel Hai College at 1 site in Israel.
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 3 inclusion and 4 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 9 Jul 2018. 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 Israel. 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?
Change in results of study questionnaire. (time frame: Each participant shall be assessed for a total duration of 6 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 9 Jul 2018.