Efficacy Study of Amazing Me Program

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Self Esteem, Body Distorted Images

Intervention / Treatment
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* Behavioral: Amazing Me


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Educators teaching 4th and 5th graders. Thus students will be on average between 9 and 11 years old. Exclusion Criteria: None.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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. | Behavioral: Amazing Me<br>* 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.<br>|
| No Intervention: Control Group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, | 
| 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. | 6 weeks after baseline | 
| 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. | 9-12 month follow up | 
| 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. | Baseline | 
| 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. | 6 weeks after baseline | 
| 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. | 9-12 month follow up | 
| 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. | Baseline | 
| 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. | 6 weeks after baseline | 
| 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. | 9-12 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Teacher Satisfaction Scale | This is a three item measure assessing satisfaction with curriculum, on a 5-point Likert scale. | baseline | 
| Teacher Satisfaction Scale | This is a three item measure assessing satisfaction with curriculum, on a 5-point Likert scale. | 6 weeks after baseline | 
| 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 | 6 weeks after baseline | 
| Knowledge Check Test | This is an 8 item measures that assesses comprehension and knowledge of the curriculum materials, concepts and goals | baseline | 
| Knowledge Check Test | This is an 8 item measures that assesses comprehension and knowledge of the curriculum materials, concepts and goals | 6 weeks after baseline | 
| Knowledge Check Test | 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 | 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 | 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 | 
| 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. | 9-12 month follow up | 
| 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?) | baseline | 
| 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?) | 6 weeks after baseline | 
| 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?) | 9-12 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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body satisfaction, self esteem, weight-based bullying and teasing