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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04754126
Other study ID # STUDY00012339
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 12, 2021
Est. completion date December 31, 2022

Study information

Verified date March 2023
Source Arizona State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. The Amazing Me intervention teaches students to be kind to themselves, their bodies, and to others.


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.


Recruitment information / eligibility

Status Completed
Enrollment 421
Est. completion date December 31, 2022
Est. primary completion date June 28, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 11 Years
Eligibility Inclusion Criteria: - Educators teaching 4th and 5th graders. Thus students will be on average between 9 and 11 years old. Exclusion Criteria: - None.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Amazing Me
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.

Locations

Country Name City State
United States Arizona State University Tempe Arizona

Sponsors (1)

Lead Sponsor Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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,
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Teacher Satisfaction Scale This is a three item measure assessing satisfaction with curriculum, on a 5-point Likert scale. baseline
Secondary Teacher Satisfaction Scale This is a three item measure assessing satisfaction with curriculum, on a 5-point Likert scale. 6 weeks after baseline
Secondary 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
Secondary Knowledge Check Test This is an 8 item measures that assesses comprehension and knowledge of the curriculum materials, concepts and goals baseline
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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