Clinical trial NCT04754126: Efficacy Study of Amazing Me Program
Official title: Amazing Me: A Body Confidence Health and Wellness Program for 4th and 5th Graders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self Esteem
Body Distorted Images
Keywords: body satisfaction
self esteem
weight-based bullying and teasing
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 421
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None.

Primary outcomes:
measure: Body-Esteem Scale
timeFrame: Baseline,
measure: Body-Esteem Scale
timeFrame: 6 weeks after baseline
measure: Body-Esteem Scale
timeFrame: 9-12 month follow up
measure: Physical Appearance Related Teasing Scale
timeFrame: Baseline
measure: Physical Appearance Related Teasing Scale
timeFrame: 6 weeks after baseline
measure: Physical Appearance Related Teasing Scale
timeFrame: 9-12 month follow up
measure: Rosenberg Self-Esteem Scale
timeFrame: Baseline
measure: Rosenberg Self-Esteem Scale
timeFrame: 6 weeks after baseline
measure: Rosenberg Self-Esteem Scale
timeFrame: 9-12 month follow up
Secondary outcomes:
measure: Teacher Satisfaction Scale
timeFrame: baseline
measure: Teacher Satisfaction Scale
timeFrame: 6 weeks after baseline
measure: Fidelity and Adherence Coding
timeFrame: 6 weeks after baseline
measure: Knowledge Check Test
timeFrame: baseline
measure: Knowledge Check Test
timeFrame: 6 weeks after baseline
measure: Knowledge Check Test
timeFrame: 9-12 month follow up
measure: Appearance Conversations Scale
timeFrame: baseline
measure: Appearance Conversations Scale
timeFrame: 6 weeks after baseline
measure: Appearance Conversations Scale
timeFrame: 9-12 month follow up
measure: Figure Rating Scale
timeFrame: baseline
measure: Figure Rating Scale
timeFrame: 6 weeks after baseline
measure: Figure Rating Scale
timeFrame: 9-12 month follow up
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Arizona State University
state: Arizona
Study officials:
References: