NCT03211468

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 9, 2018

Status Verified

July 1, 2018

Enrollment Period

11 months

First QC Date

May 7, 2017

Last Update Submit

July 5, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Each participant shall be assessed for a total duration of 6 months.

Study Arms (2)

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.

Behavioral: Clinical intervention program to prevent eating disorders

Control Group

NO INTERVENTION

No participation in intervention program.

Interventions

See previous

Intervention Program

Eligibility Criteria

Age10 Years - 16 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Female
  • Age 10-16
  • Athletes in aesthetic sports: figure skaters, dancers and gymnasts.

You may not qualify if:

  • Males
  • Females under age 10 or over 16
  • Athletes from non-aesthetic sports
  • Non-athletes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic College of Tel Hai

Kiryat Shmona, North of Israel, 1220800, Israel

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2017

First Posted

July 7, 2017

Study Start

May 1, 2017

Primary Completion

April 1, 2018

Study Completion

June 1, 2018

Last Updated

July 9, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations