NCT03216018

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

September 12, 2018

Status Verified

September 1, 2018

Enrollment Period

11 months

First QC Date

July 9, 2017

Last Update Submit

September 11, 2018

Conditions

Keywords

resilienceprevention programbody-imageself-esteem

Outcome Measures

Primary Outcomes (7)

  • 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 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 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 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 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 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 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 three times over six months, measuring a change in scores

Study Arms (2)

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.

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.

Interventions

Prevention program: "In Favor of Resilient Self"

Experimental: Prevention Program "In Favor of Resilient Self"

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Participants who filled out the questionnaires before and after the program, and whose parents signed a letter of informed consent.

You may not qualify if:

  • Participants who do not complete the questionnaires at least twice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Hai Academic College

Kiryat Shmona, North of Israel, 1220800, Israel

Location

Related Publications (1)

  • 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.

Study Design

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

Study Record Dates

First Submitted

July 9, 2017

First Posted

July 12, 2017

Study Start

June 1, 2017

Primary Completion

May 1, 2018

Study Completion

June 1, 2018

Last Updated

September 12, 2018

Record last verified: 2018-09

Locations