Primary PreventionNCT03216018
Prevention Program Promoting Self Resilience, Positive Self-Image and Body Image Among Adolescents
A study testing Prevention program: "In Favor of Resilient Self" in people with Primary Prevention, run by Tel Hai College at 1 site in Israel.
Trial summary
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-months follow-up. Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Prevention
- What is being tested?
- Prevention program: "In Favor of Resilient Self"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jun 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 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants who filled out the questionnaires before and after the program, and whose parents signed a letter of informed consent.
Who cannot join
- Participants who do not complete the questionnaires at least twice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "In Favor of Resilient Self"- A Prevention Program Promoting Positive Self-Image and Body Image Among Adolescence Aged 15-17
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-months 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, received information about the program and the study and were asked to provide informed consent.
Read the 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.
- Conditions
- Primary Prevention
- Being tested
- Prevention program: "In Favor of Resilient Self"
- Keywords
- resilience, prevention program, body-image, self-esteem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention program: "In Favor of Resilient Self"Behavioural
Prevention program: "In Favor of Resilient Self"
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Prevention Program "In Favor of Resilient Self" | Experimental | 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. Receives: Behavioral: Prevention program: "In Favor of Resilient Self" |
| No Intervention: control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Sociocultural Attitudes towards Appearance Questionnaire-4
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
Measured: Measured three times over six months, measuring a change in scores
Change from Baseline in Rosenberg Self Esteem Scale
Rosenberg Self Esteem Scale (Rosenberg, 1965)- 10 items
Measured: Measured three times over six months, measuring a change in scores
Change from Baseline in Eating Attitudes Test
Eating Attitudes Test- 26 items The Eating Attitudes validated scale for children and adolescents (Maloney, McGuire, \& Daniels, 1988)
Measured: Measured three times over six months, measuring a change in scores
Change from Baseline in Body Esteem Scale
Body Esteem Scale- 23 items Body Esteem Scale for adolescents \& adults (Mendelson, Mendelson, \& White, 2001) Weight, appearance and attribution subscales.
Measured: Measured three times over six months, measuring a change in scores
Change from Baseline in Contingencies of Self Worth Scale
Contingencies of Self Worth Scale- 25 items (Crocker et al., 2003). We used 2 subscales: Appearance and Approval from others.
Measured: Measured three times over six months, measuring a change in scores
Change from Baseline in Contour Drawing Rating Scale
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.
Measured: Measured three times over six months, measuring a change in scores
Change from Baseline in Advertising Scale
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).
Measured: Measured three times over six months, measuring a change in scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start1 Jun 2017
- Primary completion1 May 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary PreventionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 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
- NCT03216018
- Sponsor's protocol ID
- Tel-Hai College
- Status last verified
- Sep 2018
- First submitted
- 9 Jul 2017
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Golan M, Benifla S, Samo A, Alon N, Mozeikov M. Feasibility and effect of adding a concurrent parental component to a school-based wellness program using two modes of mobile-based technology - mixed methods evaluation of RCT. BMC Public Health. 2022 Feb 14;22(1):297. doi: 10.1186/s12889-022-12581-7.
PubMed 35164721
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "In Favor of Resilient Self"- A Prevention Program Promoting Positive Self-Image and Body Image Among Adolescence Aged 15-17
- ClinicalTrials.gov ID
- NCT03216018
- Acronym / sponsor ID
- Tel-Hai College
- Conditions
- Primary Prevention
- Keywords
- resilience, prevention program, body-image, self-esteem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Tel Hai CollegeUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 12 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.
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-months 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, received information about the program and the study and were asked to provide informed consent.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Prevention Program "In Favor of Resilient Self" | Experimental | Behavioral: 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. |
| No Intervention: control group | No intervention | –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. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Participants who filled out the questionnaires before and after the program, and whose parents signed a letter of informed consent.
Key exclusion criteria (1 listed)
- Participants who do not complete the questionnaires at least twice
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 |
|---|---|---|
| Prevention program: "In Favor of Resilient Self"Prevention program: "In Favor of Resilient Self" | Behavioural | Experimental: Prevention Program "In Favor of Resilient Self" |
Primary outcome
Change from Baseline in the Sociocultural Attitudes towards Appearance Questionnaire-4
Time frame: Measured three times over six months, measuring a change in scores
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
Change from Baseline in Rosenberg Self Esteem Scale
Time frame: Measured three times over six months, measuring a change in scores
Rosenberg Self Esteem Scale (Rosenberg, 1965)- 10 items
Change from Baseline in Eating Attitudes Test
Time frame: Measured three times over six months, measuring a change in scores
Eating Attitudes Test- 26 items The Eating Attitudes validated scale for children and adolescents (Maloney, McGuire, \& Daniels, 1988)
Change from Baseline in Body Esteem Scale
Time frame: Measured three times over six months, measuring a change in scores
Body Esteem Scale- 23 items Body Esteem Scale for adolescents \& adults (Mendelson, Mendelson, \& White, 2001) Weight, appearance and attribution subscales.
Change from Baseline in Contingencies of Self Worth Scale
Time frame: Measured three times over six months, measuring a change in scores
Contingencies of Self Worth Scale- 25 items (Crocker et al., 2003). We used 2 subscales: Appearance and Approval from others.
Change from Baseline in Contour Drawing Rating Scale
Time frame: Measured three times over six months, measuring a change in scores
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.
Change from Baseline in Advertising Scale
Time frame: Measured three times over six months, measuring a change in scores
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).
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 12 Sep 2018.
- Derived from this study: PubMed 35164721Golan M, Benifla S, Samo A, Alon N, Mozeikov M. Feasibility and effect of adding a concurrent parental component to a school-based wellness program using two modes of mobile-based technology - mixed methods evaluation of RCT. BMC Public Health. 2022 Feb 14;22(1):297. doi: 10.1186/s12889-022-12581-7.
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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 Prevention program: "In Favor of Resilient Self" in people with Primary Prevention, 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 1 inclusion and 1 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 12 Sep 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 from Baseline in the Sociocultural Attitudes towards Appearance Questionnaire-4 (time frame: Measured three times over six months, measuring a change in scores). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03216018, which also lists 1 linked publication.
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 12 Sep 2018.