Clinical trial NCT03216018: Prevention Program Promoting Self Resilience, Positive Self-Image and Body Image Among Adolescents
Official title: "In Favor of Resilient Self"- A Prevention Program Promoting Positive Self-Image and Body Image Among Adolescence Aged 15-17
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Prevention
Keywords: resilience
prevention program
body-image
self-esteem
Lead sponsor: Tel Hai College
Sponsor class: OTHER
First posted: 2017-07-12
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in the Sociocultural Attitudes towards Appearance Questionnaire-4
timeFrame: Measured three times over six months, measuring a change in scores
measure: Change from Baseline in Rosenberg Self Esteem Scale
timeFrame: Measured three times over six months, measuring a change in scores
measure: Change from Baseline in Eating Attitudes Test
timeFrame: Measured three times over six months, measuring a change in scores
measure: Change from Baseline in Body Esteem Scale
timeFrame: Measured three times over six months, measuring a change in scores
measure: Change from Baseline in Contingencies of Self Worth Scale
timeFrame: Measured three times over six months, measuring a change in scores
measure: Change from Baseline in Contour Drawing Rating Scale
timeFrame: Measured three times over six months, measuring a change in scores
measure: Change from Baseline in Advertising Scale
timeFrame: Measured three times over six months, measuring a change in scores
Secondary outcomes:
Other outcomes:
Locations:
city: Kiryat Shmona
country: Israel
facility: Tel Hai Academic College
state: North Of Israel
Study officials:
References:
citation: 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.