Efficacy Study of Amazing Me Program

March 30, 2023 updated by: Marisol Perez, Arizona State University

Amazing Me: A Body Confidence Health and Wellness Program for 4th and 5th Graders

The objective of the Efficacy Study of Amazing Me Program is to deliver the Amazing Me intervention and assess its efficacy. The Amazing Me intervention aims to help children between the ages of 9 and 11 build self-esteem, body confidence, and eliminate weight-based bullying and teasing. The Amazing Me intervention teaches students to be kind to themselves, their bodies, and to others.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Body dissatisfaction is one of the most robust risk factors for developing unhealthy behaviors, low self-esteem, and contributes to anxiety and depression in adolescence. Despite evidence that body dissatisfaction can emerge during the elementary school years, the majority of body confidence programs are for girls over the age of 15. There is very little to no research on interventions for elementary school children. The Body Project is an empirically supported body confidence prevention program for high school girls with over 100 articles to support its efficacy, effectiveness and theoretical model; it is the only body confidence program for youth to acquire the Blueprints Certification. Together with two 4th and 5th grade teachers, the investigators have adapted the Body Project curriculum for youth between the ages of 9 to 11 years old (i.e., 4th and 5th graders). The curriculum is called Amazing Me and will be implemented in classrooms by teachers. The curriculum was developed meeting several competencies for national health and wellness standards for elementary students. The aim of the current study is to conduct a national randomized control trial of the curriculum 100 classrooms with 4th and 5th graders.

The primary aim of the current study is to deliver the Amazing Me intervention and assess its efficacy. It is hypothesized that compared to controls, children that undergo the body confidence curriculum will report higher body satisfaction and body esteem scores, overall greater self-esteem, and will report less engagement in appearance comparisons.

Study Type

Interventional

Enrollment (Actual)

421

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Tempe, Arizona, United States, 85287
        • Arizona State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Educators teaching 4th and 5th graders. Thus students will be on average between 9 and 11 years old.

Exclusion Criteria:

  • None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Educators and students complete a baseline survey. Educators will implement 6 lessons, each 45 minutes, in the classroom. Educators are free to choose the time between lessons, so some can implement all in one week, others can choose to implement once per week. Educators are given a maximum of 6 weeks to implement the curriculum. Educators and students complete a post-program survey. Students complete a 6- and 12-month follow-up survey.
The Amazing Me Program is an evidence-based program designed to help children between the ages of 9 and 11 build self-esteem, body confidence, and eliminate weight-based bullying and teasing. This school-based curriculum satisfies national educational health requirements and provides tools for teachers to implement in 4th and 5th grade classrooms.
No Intervention: Control Group
This group will only complete online surveys that match the time when intervention group is complete the surveys. There is a baseline survey and then a post-survey 6 weeks later for both educators and students. Additionally, students will complete a 6- and 12-month follow-up survey.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body-Esteem Scale
Time Frame: 6 weeks after baseline
The Body-Esteem Scale is a 24-item self-report measure designed for use with children. The items were developed to assess how children feel about themselves and how they believe others view them. Sample items include "I like what I look like in pictures" and "There are lots of things I'd change about my looks if I could." Children responded by selecting "yes" or "no" for each item. In this study, children were also given the option of selecting "I don't want to answer." This scale has been found to be a reliable measure of body esteem in children as young as 7 years old. All items from this scale were used in the pilot study.
6 weeks after baseline
Physical Appearance Related Teasing Scale
Time Frame: Baseline
The Physical Appearance Related Teasing Scale was adapted for the current study. The original scale consists of 18 items with two factors: weight/size teasing and general appearance teasing. Items 1, 2, 3, 4, 5, 6, 14, 16, 17, 18 were used in the current study. Items 1-6 load onto the weight/size teasing factor and items 14, 16, 17-18 load onto the general appearance teasing factor. Items were modified to be developmentally appropriate. The Perception of Teasing Scale (POTS) was incorporated to measure perceptions of distress where participants were asked to rate the degree to which they were upset by the teasing on a 3-point Likert scale ranging from 1 (not upset) to 3 (very upset), modified from the original The POTS was originally developed with adults and has been used extensively with children and adolescents.
Baseline
Physical Appearance Related Teasing Scale
Time Frame: 6 weeks after baseline
The Physical Appearance Related Teasing Scale was adapted for the current study. The original scale consists of 18 items with two factors: weight/size teasing and general appearance teasing. Items 1, 2, 3, 4, 5, 6, 14, 16, 17, 18 were used in the current study. Items 1-6 load onto the weight/size teasing factor and items 14, 16, 17-18 load onto the general appearance teasing factor. Items were modified to be developmentally appropriate. The Perception of Teasing Scale (POTS) was incorporated to measure perceptions of distress where participants were asked to rate the degree to which they were upset by the teasing on a 3-point Likert scale ranging from 1 (not upset) to 3 (very upset), modified from the original The POTS was originally developed with adults and has been used extensively with children and adolescents.
6 weeks after baseline
Rosenberg Self-Esteem Scale
Time Frame: Baseline
A 10-item scale that measures global self-esteem by measuring both positive and negative feelings about the self. Items were modified to be developmentally appropriate for children. Example items include "I like myself" and "I feel there are a lot of good things about me." The scale is uni-dimensional. All items are answered using a 4-point Likert scale format ranging from "strongly agree" to "strongly disagree." In this study, children were also given the option of selecting "I don't want to answer." All items from this scale were used in the pilot study.
Baseline
Rosenberg Self-Esteem Scale
Time Frame: 6 weeks after baseline
A 10-item scale that measures global self-esteem by measuring both positive and negative feelings about the self. Items were modified to be developmentally appropriate for children. Example items include "I like myself" and "I feel there are a lot of good things about me." The scale is uni-dimensional. All items are answered using a 4-point Likert scale format ranging from "strongly agree" to "strongly disagree." In this study, children were also given the option of selecting "I don't want to answer." All items from this scale were used in the pilot study.
6 weeks after baseline
Body-Esteem Scale
Time Frame: Baseline,
The Body-Esteem Scale is a 24-item self-report measure designed for use with children. The items were developed to assess how children feel about themselves and how they believe others view them. Sample items include "I like what I look like in pictures" and "There are lots of things I'd change about my looks if I could." Children responded by selecting "yes" or "no" for each item. In this study, children were also given the option of selecting "I don't want to answer." This scale has been found to be a reliable measure of body esteem in children as young as 7 years old. All items from this scale were used in the pilot study.
Baseline,
Body-Esteem Scale
Time Frame: 9-12 month follow up
The Body-Esteem Scale is a 24-item self-report measure designed for use with children. The items were developed to assess how children feel about themselves and how they believe others view them. Sample items include "I like what I look like in pictures" and "There are lots of things I'd change about my looks if I could." Children responded by selecting "yes" or "no" for each item. In this study, children were also given the option of selecting "I don't want to answer." This scale has been found to be a reliable measure of body esteem in children as young as 7 years old. All items from this scale were used in the pilot study.
9-12 month follow up
Physical Appearance Related Teasing Scale
Time Frame: 9-12 month follow up
The Physical Appearance Related Teasing Scale was adapted for the current study. The original scale consists of 18 items with two factors: weight/size teasing and general appearance teasing. Items 1, 2, 3, 4, 5, 6, 14, 16, 17, 18 were used in the current study. Items 1-6 load onto the weight/size teasing factor and items 14, 16, 17-18 load onto the general appearance teasing factor. Items were modified to be developmentally appropriate. The Perception of Teasing Scale (POTS) was incorporated to measure perceptions of distress where participants were asked to rate the degree to which they were upset by the teasing on a 3-point Likert scale ranging from 1 (not upset) to 3 (very upset), modified from the original The POTS was originally developed with adults and has been used extensively with children and adolescents.
9-12 month follow up
Rosenberg Self-Esteem Scale
Time Frame: 9-12 month follow up
A 10-item scale that measures global self-esteem by measuring both positive and negative feelings about the self. Items were modified to be developmentally appropriate for children. Example items include "I like myself" and "I feel there are a lot of good things about me." The scale is uni-dimensional. All items are answered using a 4-point Likert scale format ranging from "strongly agree" to "strongly disagree." In this study, children were also given the option of selecting "I don't want to answer." All items from this scale were used in the pilot study.
9-12 month follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Teacher Satisfaction Scale
Time Frame: baseline
This is a three item measure assessing satisfaction with curriculum, on a 5-point Likert scale.
baseline
Teacher Satisfaction Scale
Time Frame: 6 weeks after baseline
This is a three item measure assessing satisfaction with curriculum, on a 5-point Likert scale.
6 weeks after baseline
Fidelity and Adherence Coding
Time Frame: 6 weeks after baseline
This is a 10 item measure coded by raters assessing the extent to which teacher's administer the program as prescribed
6 weeks after baseline
Knowledge Check Test
Time Frame: baseline
This is an 8 item measures that assesses comprehension and knowledge of the curriculum materials, concepts and goals
baseline
Knowledge Check Test
Time Frame: 6 weeks after baseline
This is an 8 item measures that assesses comprehension and knowledge of the curriculum materials, concepts and goals
6 weeks after baseline
Appearance Conversations Scale
Time Frame: baseline
The Appearance Conversations Scale assesses the frequency with which participants report talking about their bodies and appearance with friends. In the original measure, responses are rated on a 5-point Likert scale ranging from "never" (1) to "very often" (5). In the current study, the scale was modified to a 3-point Likert scale ranging from "never" (1) to "a lot" (3) to be developmentally appropriate.
baseline
Appearance Conversations Scale
Time Frame: 6 weeks after baseline
The Appearance Conversations Scale assesses the frequency with which participants report talking about their bodies and appearance with friends. In the original measure, responses are rated on a 5-point Likert scale ranging from "never" (1) to "very often" (5). In the current study, the scale was modified to a 3-point Likert scale ranging from "never" (1) to "a lot" (3) to be developmentally appropriate.
6 weeks after baseline
Figure Rating Scale
Time Frame: baseline
were developed based on adult figure drawings by Stunkard, Sorenson, and Schulsinger (1983). Figures were created to illustrate body weight ranging from very thin to obese. This scale can be used to assess preferences and perceptions of self, ideal self, ideal other child, other adult, and ideal other adult. In the current study, "self" and "other-gender" were used. For example, if participants identified as girls, they were presented with corresponding figure drawings for "self" ("which picture looks the most like you?") and figure drawings of boys for "other-gender" ("which picture shows the way you think is best for girls/boys to look?")
baseline
Figure Rating Scale
Time Frame: 6 weeks after baseline
were developed based on adult figure drawings by Stunkard, Sorenson, and Schulsinger (1983). Figures were created to illustrate body weight ranging from very thin to obese. This scale can be used to assess preferences and perceptions of self, ideal self, ideal other child, other adult, and ideal other adult. In the current study, "self" and "other-gender" were used. For example, if participants identified as girls, they were presented with corresponding figure drawings for "self" ("which picture looks the most like you?") and figure drawings of boys for "other-gender" ("which picture shows the way you think is best for girls/boys to look?")
6 weeks after baseline
Knowledge Check Test
Time Frame: 9-12 month follow up
This is an 8 item measures that assesses comprehension and knowledge of the curriculum materials, concepts and goals
9-12 month follow up
Appearance Conversations Scale
Time Frame: 9-12 month follow up
The Appearance Conversations Scale assesses the frequency with which participants report talking about their bodies and appearance with friends. In the original measure, responses are rated on a 5-point Likert scale ranging from "never" (1) to "very often" (5). In the current study, the scale was modified to a 3-point Likert scale ranging from "never" (1) to "a lot" (3) to be developmentally appropriate.
9-12 month follow up
Figure Rating Scale
Time Frame: 9-12 month follow up
were developed based on adult figure drawings by Stunkard, Sorenson, and Schulsinger (1983). Figures were created to illustrate body weight ranging from very thin to obese. This scale can be used to assess preferences and perceptions of self, ideal self, ideal other child, other adult, and ideal other adult. In the current study, "self" and "other-gender" were used. For example, if participants identified as girls, they were presented with corresponding figure drawings for "self" ("which picture looks the most like you?") and figure drawings of boys for "other-gender" ("which picture shows the way you think is best for girls/boys to look?")
9-12 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2021

Primary Completion (Actual)

June 28, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

February 5, 2021

First Submitted That Met QC Criteria

February 10, 2021

First Posted (Actual)

February 15, 2021

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00012339

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Funder and IRB must first approve any sharing of IPD with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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