Primary PreventionNCT03540277
Prevention Program- Promoting Self Resilience, Positive Self-Image and Body Image Among Adolescents and Their Parents
A study testing Experimental: Prevention Program "young In Favor of Myself", active parents and Experimental: Prevention Program "young In Favor of Myself", no parental involvement in people with Primary Prevention, run by Tel Hai College at 1 site in Israel.
Trial summary
Cluster-Randomized Clinical trial, which includes the development and activation of an intervention program among young adolescents and their parents. Study hypothesis is that the intervention program will yield improvement in adolescents whose parents participated in the program, in comparison with the adolescents… Read more about this study
- Who is it for?
- Ages 10 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Prevention
- What is being tested?
- Experimental: Prevention Program "young In Favor of Myself", active parents and Experimental: Prevention Program "young In Favor of Myself", no parental involvement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2018to 1 Dec 2021
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parents of children 10-12 years old
- 10-12-year-old children of participating parents
- Participants who filled out the questionnaires before and after the program
- Participants whose parents signed a letter of informed consent.
Who cannot join
- Participants who didn't complete the questionnaires at baseline or at least twice.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Addition of Parental Component to the Program "Young In Favor of Myself" on Participating Parents and Their Children
Cluster-Randomized Clinical trial, which includes the development and activation of an intervention program among young adolescents and their parents. Study hypothesis is that the intervention program will yield improvement in adolescents whose parents participated in the program, in comparison with the adolescents whose parents weren't involved in the intervention. 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. 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
Early adolescent (10-13 years) is characterized by hormonal changes and accelerated physiological growth. Significant risk factors for the physical and mental health of children and adolescents include, among other things, disordered eating patterns, overweight and reduced physical activity, low self-esteem and negative body image.
"In Favor of Myself" is a preventive intervention program. The program's primary goal is to increase adolescents' self-esteem and to prevent negative self-image and body image, as well as to development media literacy. In this study, the investigators will focus on the "Young In Favor of Myself " program, designed for ages 10-12, grades 5 and 6, and its main core is the development of self-care. To increase the effect of "Young In Favor of Myself " program, on the adolescents, the investigators have developed a program that will be passed on to parents through a telephone application. The study will first assess the parents' influence on the program, and then evaluate the difference in adolescent outcomes from the program with or without this supplement.
Results will be measured using the study questionnaire, to be filled out by the participants (both parents and adolescents) before, after, and three months after the completion of the program. The questionnaire will include validated questionnaires with good psychometric qualities. 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.
- Conditions
- Primary Prevention
- Being tested
- Experimental: Prevention Program "young In Favor of Myself", active parents, Experimental: Prevention Program "young In Favor of Myself", no parental involvement
- Keywords
- prevention program, body-image, self-esteem, parents, adolescents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Prevention Program "young In Favor of Myself", active parentsBehavioural
Prevention program: "young In Favor of Myself", with parent participation
Experimental: Prevention Program "young In Favor of Myself", no parental involvementBehavioural
Prevention program: "young In Favor of Myself", without parent participation
| Study group | Role | What they receive |
|---|---|---|
| Prevention Program "young In Favor of Myself", active parents | Experimental | The program "young In Favor of Myself" will be delivered to adolescence aged 10-12, over 3 months. The program contains nine weekly, 90-min sessions that focus on Media literacy, self-esteem, self-image and body image. The parents will also participate by a phone app that will pass the parents activities to do with their children, in parallel to the program. All participants will complete a self-report questionnaire at baseline, after the program ends, and three months after the completion of the program. Receives: Behavioral: Experimental: Prevention Program "young In Favor of Myself", active parents |
| Prevention Program "young In Favor of Myself", passive parents | Active comparator | The program "young In Favor of Myself" will be delivered to adolescence aged 10-12, over 3 months. The program contains nine weekly, 90-min sessions that focus on Media literacy, self-esteem, self-image and body image. The parents won't participate in the program, they will get only a brochure about Media literacy, self-esteem, self-image and body image. All participants will complete a self-report questionnaire at baseline, after the program ends, and three months after the completion of the program. Receives: Behavioral: Experimental: Prevention Program "young In Favor of Myself", no parental involvement |
| control group | No intervention | The control group will not receive the intervention program. The control group will complete the same self-report questionnaire as the intervention group at baseline, after the program ends, and three months after the completion of the program. |
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, Affects by Media subscale.
The Sociocultural Attitudes Towards Appearance Questionnaire (Schaefer et al., 2015). The investigators included the Media subscale, including 4 items. Items are rated on a 5-point scale: (1) always, (2) often, (3) sometimes, (4) rarely, (5) never. The total score is based on computing the average. A higher score indicates higher pressure from the media to change one's look.
Measured: Measured three times over six months: at baseline, after the program ends, and three months after the completion of the program, measuring a change in scores
Change from Baseline in Rosenberg Self Esteem Scale
Rosenberg Self Esteem Scale (Rosenberg, 1965)- 10 items. Scoring involves a method of combined ratings. Low self-esteem responses are "disagree" or "strongly disagree" on items 1, 3, 4, 7, 10, and "strongly agree" or "agree" on items 2, 5, 6, 8, 9. Two or three out of three correct responses to items 3, 7, and 9 are scored as one item. One or two out of two correct responses for items 4 and 5 are considered as a single item; items 1,8, and 10 are scored as individual items; and combined correct responses (one or two out of two) to items 2 and 6 are considered to be a single item.
Measured: Measured three times over six months: at baseline, after the program ends, and three months after the completion of the program, measuring a change in scores
Change from Baseline in Body Esteem Scale
Body Esteem Scale- This questionnaire examines self-esteem of body and physical appearance and consists of 3 subscales: appearance (10 items), weight (8 items) and attribution 187 to others (5 items). Items are rated on a 5-point scale: (1) never, (2) rarely, (3) sometimes, (4) 188 often, and (5) always. A higher score indicates higher body-esteem (Mendelson, Mendelson, \& White, 2001)
Measured: Measured three times over six months: at baseline, after the program ends, and three months after the completion of the program, measuring a change in scores
Change from Baseline in Eating Disorder Examination- Questionnaire (EDE-Q8)
Eating Disorder Examination- Questionnaire short version (EDE-Q8). The items are rated on a 6-point scale: (1) never, (2) rarely, (3) sometimes, (4) often, (5) usually, and (6) always. EDE-Q provides assessment of eating disorder psychopathology related to anorexia nervosa (AN), bulimia nervosa (BN), and binge-eating disorder (BED). (Kliem et al, 2016)
Measured: Measured three times over six months: at baseline, after the program ends, and three months after the completion of the program, 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 which participants choose from: higher number of strategies identified indicate better media literacy. (Golan et al., 2013).
Measured: Measured three times over six months: at baseline, after the program ends, and three months after the completion of the program, measuring a change in scores
Change from Baseline in Self-Caring
Developed by Prof. Moria Golan and assessed in previous research. Includes 14 items which are rated on a 4-point scale: (1) never, (2) rarely, (3) sometimes, (4) always. Items are summed, and higher scores indicate higher self-care behaviors. This questionnaire was designed to assess self care behaviors in adolescents.
Measured: Measured three times over six months: at baseline, after the program ends, and three months after the completion of the program, measuring a change in scores
Secondary outcomes (1)
The 11-item Knowledge Test BEC
The 11-item Knowledge Test BEC was developed to assess knowledge of parenting strategies to prevent unhealthy eating and body dissatisfaction in young children. Scores are summed across the 11 items giving a total score ranging between 11 and 44, with higher scores indicating greater knowledge of parenting strategies.
Measured: Measured three times over six months: at baseline, after the program ends, and three months after the completion of the program, 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 posted30 May 2018
- Study start1 Nov 2018
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
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
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Hai College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moria Golan, Prof., Principal investigator, Tel Hai College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540277
- Sponsor's protocol ID
- Tel Hai College.
- Status last verified
- Jan 2022
- First submitted
- 26 Apr 2018
- Last updated
- 24 Jan 2022
- 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 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Addition of Parental Component to the Program "Young In Favor of Myself" on Participating Parents and Their Children
- ClinicalTrials.gov ID
- NCT03540277
- Acronym / sponsor ID
- Tel Hai College.
- Conditions
- Primary Prevention
- Keywords
- prevention program, body-image, self-esteem, parents, adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Tel Hai CollegeUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 30 May 2018 (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.
Cluster-Randomized Clinical trial, which includes the development and activation of an intervention program among young adolescents and their parents. Study hypothesis is that the intervention program will yield improvement in adolescents whose parents participated in the program, in comparison with the adolescents whose parents weren't involved in the intervention. 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. 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
Early adolescent (10-13 years) is characterized by hormonal changes and accelerated physiological growth. Significant risk factors for the physical and mental health of children and adolescents include, among other things, disordered eating patterns, overweight and reduced physical activity, low self-esteem and negative body image.
"In Favor of Myself" is a preventive intervention program. The program's primary goal is to increase adolescents' self-esteem and to prevent negative self-image and body image, as well as to development media literacy. In this study, the investigators will focus on the "Young In Favor of Myself " program, designed for ages 10-12, grades 5 and 6, and its main core is the development of self-care. To increase the effect of "Young In Favor of Myself " program, on the adolescents, the investigators have developed a program that will be passed on to parents through a telephone application. The study will first assess the parents' influence on the program, and then evaluate the difference in adolescent outcomes from the program with or without this supplement.
Results will be measured using the study questionnaire, to be filled out by the participants (both parents and adolescents) before, after, and three months after the completion of the program. The questionnaire will include validated questionnaires with good psychometric qualities. 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prevention Program "young In Favor of Myself", active parents | Experimental | Behavioral: Experimental: Prevention Program "young In Favor of Myself", active parentsThe program "young In Favor of Myself" will be delivered to adolescence aged 10-12, over 3 months. The program contains nine weekly, 90-min sessions that focus on Media literacy, self-esteem, self-image and body image. The parents will also participate by a phone app that will pass the parents activities to do with their children, in parallel to the program. All participants will complete a self-report questionnaire at baseline, after the program ends, and three months after the completion of the program. |
| Prevention Program "young In Favor of Myself", passive parents | Active comparator | Behavioral: Experimental: Prevention Program "young In Favor of Myself", no parental involvementThe program "young In Favor of Myself" will be delivered to adolescence aged 10-12, over 3 months. The program contains nine weekly, 90-min sessions that focus on Media literacy, self-esteem, self-image and body image. The parents won't participate in the program, they will get only a brochure about Media literacy, self-esteem, self-image and body image. All participants will complete a self-report questionnaire at baseline, after the program ends, and three months after the completion of the program. |
| control group | No intervention | –The control group will not receive the intervention program. The control group will complete the same self-report questionnaire as the intervention group at baseline, after the program ends, and three months after the completion of the program. |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Parents of children 10-12 years old
- 10-12-year-old children of participating parents
- Participants who filled out the questionnaires before and after the program
- Participants whose parents signed a letter of informed consent.
Key exclusion criteria (1 listed)
- Participants who didn't complete the questionnaires at baseline or 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 |
|---|---|---|
| Experimental: Prevention Program "young In Favor of Myself", active parentsPrevention program: "young In Favor of Myself", with parent participation | Behavioural | Prevention Program "young In Favor of Myself", active parents |
| Experimental: Prevention Program "young In Favor of Myself", no parental involvementPrevention program: "young In Favor of Myself", without parent participation | Behavioural | Prevention Program "young In Favor of Myself", passive parents |
Primary outcome
Change from Baseline in the Sociocultural Attitudes towards Appearance Questionnaire-4, Affects by Media subscale.
Time frame: Measured three times over six months: at baseline, after the program ends, and three months after the completion of the program, measuring a change in scores
The Sociocultural Attitudes Towards Appearance Questionnaire (Schaefer et al., 2015). The investigators included the Media subscale, including 4 items. Items are rated on a 5-point scale: (1) always, (2) often, (3) sometimes, (4) rarely, (5) never. The total score is based on computing the average. A higher score indicates higher pressure from the media to change one's look.
Change from Baseline in Rosenberg Self Esteem Scale
Time frame: Measured three times over six months: at baseline, after the program ends, and three months after the completion of the program, measuring a change in scores
Rosenberg Self Esteem Scale (Rosenberg, 1965)- 10 items. Scoring involves a method of combined ratings. Low self-esteem responses are "disagree" or "strongly disagree" on items 1, 3, 4, 7, 10, and "strongly agree" or "agree" on items 2, 5, 6, 8, 9. Two or three out of three correct responses to items 3, 7, and 9 are scored as one item. One or two out of two correct responses for items 4 and 5 are considered as a single item; items 1,8, and 10 are scored as individual items; and combined correct responses (one or two out of two) to items 2 and 6 are considered to be a single item.
Change from Baseline in Body Esteem Scale
Time frame: Measured three times over six months: at baseline, after the program ends, and three months after the completion of the program, measuring a change in scores
Body Esteem Scale- This questionnaire examines self-esteem of body and physical appearance and consists of 3 subscales: appearance (10 items), weight (8 items) and attribution 187 to others (5 items). Items are rated on a 5-point scale: (1) never, (2) rarely, (3) sometimes, (4) 188 often, and (5) always. A higher score indicates higher body-esteem (Mendelson, Mendelson, \& White, 2001)
Change from Baseline in Eating Disorder Examination- Questionnaire (EDE-Q8)
Time frame: Measured three times over six months: at baseline, after the program ends, and three months after the completion of the program, measuring a change in scores
Eating Disorder Examination- Questionnaire short version (EDE-Q8). The items are rated on a 6-point scale: (1) never, (2) rarely, (3) sometimes, (4) often, (5) usually, and (6) always. EDE-Q provides assessment of eating disorder psychopathology related to anorexia nervosa (AN), bulimia nervosa (BN), and binge-eating disorder (BED). (Kliem et al, 2016)
Change from Baseline in Advertising Scale
Time frame: Measured three times over six months: at baseline, after the program ends, and three months after the completion of the program, 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 which participants choose from: higher number of strategies identified indicate better media literacy. (Golan et al., 2013).
Change from Baseline in Self-Caring
Time frame: Measured three times over six months: at baseline, after the program ends, and three months after the completion of the program, measuring a change in scores
Developed by Prof. Moria Golan and assessed in previous research. Includes 14 items which are rated on a 4-point scale: (1) never, (2) rarely, (3) sometimes, (4) always. Items are summed, and higher scores indicate higher self-care behaviors. This questionnaire was designed to assess self care behaviors in adolescents.
1 secondary outcome
The 11-item Knowledge Test BEC
Time frame: Measured three times over six months: at baseline, after the program ends, and three months after the completion of the program, measuring a change in scores
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 24 Jan 2022.
- 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.
Moria Golan, Prof. principal investigator
Tel Hai College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Prevention Program "young In Favor of Myself", active parents and Experimental: Prevention Program "young In Favor of Myself", no parental involvement 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 4 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 24 Jan 2022. 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, Affects by Media subscale. (time frame: Measured three times over six months: at baseline, after the program ends, and three months after the completion of the program, measuring a change in scores). The study lists 6 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 NCT03540277, 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 24 Jan 2022.