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Self EsteemNCT04754126

Efficacy Study of Amazing Me Program

A study testing Amazing Me in people with Self Esteem and Body Distorted Images, run by Arizona State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 9 to 11 yearsHealthy volunteers can take part
Conditions the study is for
Self Esteem, Body Distorted Images
What is being tested?
Amazing Me
Could I receive a placebo?
No, everyone receives an active treatment
How many people
421 participants
Where
1 siteUnited States
Study dates
12 Mar 2021to 31 Dec 2022
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 9 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • None.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Arizona State University

    Tempe, Arizona, 85287

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Amazing Me
Keywords
body satisfaction, self esteem, weight-based bullying and teasing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Amazing MeBehavioural

    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.

Study groups in NCT04754126
Study groupRoleWhat they receive
Intervention GroupExperimentalEducators 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.
Receives: Behavioral: Amazing Me
Control GroupNo interventionThis 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Body-Esteem Scale

    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.

    Measured: Baseline,

  2. Body-Esteem Scale

    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.

    Measured: 6 weeks after baseline

  3. Body-Esteem Scale

    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.

    Measured: 9-12 month follow up

  4. Physical Appearance Related Teasing Scale

    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.

    Measured: Baseline

  5. Physical Appearance Related Teasing Scale

    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.

    Measured: 6 weeks after baseline

  6. Physical Appearance Related Teasing Scale

    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.

    Measured: 9-12 month follow up

  7. Rosenberg Self-Esteem Scale

    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.

    Measured: Baseline

  8. Rosenberg Self-Esteem Scale

    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.

    Measured: 6 weeks after baseline

  9. Rosenberg Self-Esteem Scale

    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.

    Measured: 9-12 month follow up

Secondary outcomes (12)
  1. Teacher Satisfaction Scale

    This is a three item measure assessing satisfaction with curriculum, on a 5-point Likert scale.

    Measured: baseline

  2. Teacher Satisfaction Scale

    This is a three item measure assessing satisfaction with curriculum, on a 5-point Likert scale.

    Measured: 6 weeks after baseline

  3. Fidelity and Adherence Coding

    This is a 10 item measure coded by raters assessing the extent to which teacher's administer the program as prescribed

    Measured: 6 weeks after baseline

  4. Knowledge Check Test

    This is an 8 item measures that assesses comprehension and knowledge of the curriculum materials, concepts and goals

    Measured: baseline

  5. Knowledge Check Test

    This is an 8 item measures that assesses comprehension and knowledge of the curriculum materials, concepts and goals

    Measured: 6 weeks after baseline

  6. Knowledge Check Test

    This is an 8 item measures that assesses comprehension and knowledge of the curriculum materials, concepts and goals

    Measured: 9-12 month follow up

  7. Appearance Conversations Scale

    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.

    Measured: baseline

  8. Appearance Conversations Scale

    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.

    Measured: 6 weeks after baseline

  9. Appearance Conversations Scale

    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.

    Measured: 9-12 month follow up

  10. Figure Rating Scale

    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?")

    Measured: baseline

  11. Figure Rating Scale

    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?")

    Measured: 6 weeks after baseline

  12. Figure Rating Scale

    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?")

    Measured: 9-12 month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2021
  2. Study start12 Mar 2021
  3. Primary completion28 Jun 2022
  4. Study completion31 Dec 2022

Resources

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
Model description
A randomized controlled trail will be conducted to ascertain the effectiveness of the Amazing Me intervention in 9-11 year old children. The randomized controlled trial will consist of an intervention and control group. Between 100 to 180 classrooms will be randomized to control or intervention condition. Randomization distribution will be 50%; thus, half of the educators/classrooms will be in the intervention and half in the control. We estimate about 30 students per teacher, yielding a maximum of 2,700 students randomized to intervention and 2,700 students randomized to control. Educators and school districts will be recruited to participate. Educators and students will complete an online baseline survey and another survey after the intervention. Finally, a 6-month and 12-month follow-up survey will be conducted for students.
Masking
None (open label)
Enrolment
421 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04754126
Sponsor's protocol ID
STUDY00012339
Status last verified
Mar 2023
First submitted
5 Feb 2021
Last updated
3 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Funder and IRB must first approve any sharing of IPD with other researchers.

Questions about this trial

What is this clinical trial studying?

A study testing Amazing Me in people with Self Esteem and Body Distorted Images, run by Arizona State University at 1 site in United States.

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 3 Apr 2023. 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 United States. 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?

Body-Esteem Scale (time frame: Baseline,). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 3 Apr 2023; AzTrials last refreshed its copy on 27 Oct 2026.

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