- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03216018
Prevention Program Promoting Self Resilience, Positive Self-Image and Body Image Among Adolescents
"In Favor of Resilient Self"- A Prevention Program Promoting Positive Self-Image and Body Image Among Adolescence Aged 15-17
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is a group randomized controlled trial. High school classes were allocated by randomization to the intervention or control group by a Randomization function in Excel computer program. Outcomes were measured by questionnaire at pre-intervention, post-intervention and 3-month follow-up. The study protocol was approved by Tel Hai College institutional review board. Parents of all participants, in the intervention and in the control group, shall receive information about the program and the study and shall be asked to provide informed consent.
Participants and setting: A high school in the northern region of Israel was recruited for the study. 9th and 10th grade classes were chosen to participate in the study, all mixed gender classes. All data will be collected within the school setting.
Program description: "In Favor of a Resilient Self" is an interactive, cognitive behavior program aiming to address low resilience, low self-esteem and body dissatisfaction. This program is part of a series of intervention programs named "In Favor of Myself" which has been in development since 2008. This resilience-based program contains a range of coping strategies to help adolescents improve resilience, self-esteem and body image. The program consists of nine 90-min sessions delivered by one group leader in the presence of the classes' teachers. Participants in the control group shall receive one session of 90 minutes of health nutrition education.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Of Israel
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Kiryat Shmona, North Of Israel, Israel, 1220800
- Tel Hai Academic College
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• Participants who filled out the questionnaires before and after the program, and whose parents signed a letter of informed consent.
Exclusion Criteria:
• Participants who do not complete the questionnaires at least twice
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Experimental: Prevention Program "In Favor of Resilient Self"
The program "In Favor of Resilient Self" delivered to adolescence aged 15-17, over 3 months.
The program contained nine weekly 90-min sessions that focus on enhancing self- resilience, self-esteem, self-image, body image.
All participants will complete a self-report questionnaire at baseline, conclusion and 3 months after program conclusion.
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Prevention program: "In Favor of Resilient Self"
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NO_INTERVENTION: No Intervention: control group
The control group didn't receive the intervention program, instead they received a lesson on healthy nutrition.
The control group will complete the same self-report questionnaire as the intervention group at baseline, conclusion and 3 months after program conclusion.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change from Baseline in the Sociocultural Attitudes towards Appearance Questionnaire-4
Time Frame: Measured three times over six months, measuring a change in scores
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The Sociocultural Attitudes Towards Appearance Questionnaire (Schaefer et al., 2015) We included 3 subscales: Internalization - Thin/Low Body Fat, Internalization - Muscular/Athletic, Pressures - Media- 14 items
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Measured three times over six months, measuring a change in scores
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Change from Baseline in Rosenberg Self Esteem Scale
Time Frame: Measured three times over six months, measuring a change in scores
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Rosenberg Self Esteem Scale (Rosenberg, 1965)- 10 items
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Measured three times over six months, measuring a change in scores
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Change from Baseline in Eating Attitudes Test
Time Frame: Measured three times over six months, measuring a change in scores
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Eating Attitudes Test- 26 items The Eating Attitudes validated scale for children and adolescents (Maloney, McGuire, & Daniels, 1988)
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Measured three times over six months, measuring a change in scores
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Change from Baseline in Body Esteem Scale
Time Frame: Measured three times over six months, measuring a change in scores
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Body Esteem Scale- 23 items Body Esteem Scale for adolescents & adults (Mendelson, Mendelson, & White, 2001) Weight, appearance and attribution subscales.
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Measured three times over six months, measuring a change in scores
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Change from Baseline in Contingencies of Self Worth Scale
Time Frame: Measured three times over six months, measuring a change in scores
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Contingencies of Self Worth Scale- 25 items (Crocker et al., 2003).
We used 2 subscales: Appearance and Approval from others.
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Measured three times over six months, measuring a change in scores
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Change from Baseline in Contour Drawing Rating Scale
Time Frame: Measured three times over six months, measuring a change in scores
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Contour Drawing Rating Scale- 3 items The Figure Body Images (Collins et al., 1981).
It contains 9 figures with gender differences, the participants need to choose the figure which reflects themselves and their ideal figure goal.
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Measured three times over six months, measuring a change in scores
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Change from Baseline in Advertising Scale
Time Frame: Measured three times over six months, measuring a change in scores
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The Advertising scale contains 1 item- Identification of strategies used by media.
This question is reflected as a protective factor.
It contains 8 different strategies (Golan et al., 2013).
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Measured three times over six months, measuring a change in scores
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Tel-Hai College
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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