- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07615088
Feasibility and Acceptability of the BE REAL Let's Eat Curriculum in Middle Schoolers
Be Real's 'Let's Eat' Middle School Curriculum: A Feasibility and Acceptability Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rationale: There is widespread, harmful 'diet culture' messages which state that one needs to have the ideal body to be happy, healthy, and desirable and the way you achieve that is through a restrictive dieting. It has been well-studied that these messages apply pressure on adolescents to conform to unrealistic ideals which have been associated with body dissatisfaction, disordered eating, and lower well-being. Of salience to the present study, school is an important environment that can promote 'diet culture' messages, and specifically in health or physical activity or gym classes. For instance, in one study, researchers interviewed 150 adolescents who received medical treatment for anorexia nervosa and found that health education was attributed as a trigger to the eating disorder in 14% of the sample and their eating disorder was more likely to start younger with health education. Moreover, 2018 Health Textbooks have been found to teach students to count calories, log food, promote "good" versus "bad" foods all of which have been associated with disordered eating and eating disorders.
Furthermore, middle school is a sensitive period for developing one's eating behavior as they are experiencing changing social environments (i.e., elementary to middle school), increased autonomy and perceived independence, and cognitive and affective changes stimulated by puberty, which further sensitize individuals to learning new behaviors. To expand on adolescent changes with puberty, the changes in some students' physical bodies add another area in which 'diet culture' can influence adolescents' eating behaviors. The adolescent's eating behaviors can also vary by gender identity and cultural practices of eating. For example, in a qualitative study involving boys and girls discussing their food habits, both genders discussed anti-fat attitudes; however, girls described more societal pressures to be thin as a motivation for food restriction than boys. Another example is the differences in food choices and preferences based on cultural diets, such as the typical dishes prepared by parents from different ethnic backgrounds. In summary, adolescence is an important period to intervene, and given the known presence of diet culture in many of the current school programs, the Be Real 'Let's Eat' Curriculum is a novel approach to eating that does not include 'diet culture' messaging and is culturally sensitive to diverse youth experiences.
Let's Eat program:
BE REAL's Let's Eat is an evidence-informed schools-based curriculum that was developed in a multinational collaboration of established researchers with expertise in adolescent body image, disorder eating, nutrition and health education, and public health professionals. Let's Eat teaches "tuned-in eating," a holistic eating practice informed by intuitive and mindful eating, and how to apply it within the state and federal guidelines for nutrition education. The main goals of "tuned-in eating" are for adolescents to learn about physiological and emotional signals and experiences related to eating and learn how to make food choices based on their body's needs and preferences. Students are also exposed to the importance of eating for pleasure or enjoyment and of the social or community aspects of eating. This is a gender-neutral, inclusive curriculum that also addresses the role of culture with food and addresses the other messaging around food such as 'diet culture.' The program is a 3 lesson, teacher-led program delivered to 6th & 8th graders [See Attachments for an outline of the program].
This is the first trial of this multi-component eating and nutrition curriculum that may prevent against eating disorders and improve nutrition in adolescents.
Aim/objectives:
The purpose of this study is to evaluate the feasibility and acceptability of 'Let's Eat' and its capacity to change eating behavior and body appearance/functionality considerations in adolescents aged 11-14 years. This pilot study aims to ascertain whether the 'Let's Eat' curriculum a.) is considered acceptable by adolescents and their teachers, b.) is feasible for delivery as part of the middle school health curriculum, c.) preliminary efficacy of the curriculum to increase intuitive eating, eating competence, body acceptance, and well-being, d.) met the nutrition knowledge goals of select federal and state nutrition curriculum standards.
Theoretical rationale: The program teaches "tuned-in" eating which is based on intuitive eating. Intuitive eating emphasizes integrating the body's physical cues to eat (i.e., hunger and fullness cues) along with the individual's energy needs, community, and/or food preference to decide on what and how much food to eat. Intuitive eating is a proposed alternative to restrictive diets and longitudinal research has demonstrated that greater intuitive eating in adolescence predicts lower depressive symptoms, disordered eating, and body dissatisfaction in young adulthood. It is theorized with the acceptance model of intuitive eating, that increasing individual's trust and reliance on internal body cues also transfers to overal increase in body satisfaction and well-being since eating serves as an essential example of a positive body functioning. Therefore, the proposed intervention may improve eating behaviors, body image, and overall well-being.
Hypotheses: It is anticipated that the curriculum will be evaluated as acceptable by students and teachers, feasibly delivered, and that there will be statistically significant changes in outcome measures among adolescents who receive the curriculum; specifically we would expect significant increases in intuitive eating, eating competence, body acceptance, nutrition knowledge, and well-being between pre and post intervention.
Overall, the study seeks to provide some evidence of proof-of-concept for the curriculum to teach state and federally designated nutrition information without an emphasis on weight and diet culture in it. Additionally, to note how the curriculum goes above in improving other related domains of well-being and body image, which can be negatively impacted by the current, weight-focused curriculum (i.e., increase the risk of disordered eating post-exposure).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
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Portland, Oregon, United States, 97206
- Kellogg Middle School
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Portland, Oregon, United States, 97225
- West Sylvan Middle School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- must attend a partnering middle school in the Portland Public School district
- be between the ages of 11-14 years old
- be in either grade 6 or grade 8
Exclusion Criteria:
- not attending a partnering middle school in the Portland Public School district
- be younger than 11 years old
- be older than 14 years old
- not in the 6th or 8th grade
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Let's Eat Nutrition Curriculum
Students will receive a 3-lesson nutrition curriculum based in anti-diet culture, weight-neutral philosophies on eating flexibly in response to internal bodily cues, for pleasure, and for community.
|
Students will receive a 3-lesson nutrition curriculum based in anti-diet culture, weight-neutral philosophies on eating flexibly in response to internal bodily cues, for pleasure, and for community.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of Implementing the Let's Eat Curriculum
Time Frame: from baseline to within a week of completing the curriculum
|
This will be examined through multiple metrics including meeting participant recruitment goals; student attrition; the amount of missing data; the ability to accurately track student pre-post data
|
from baseline to within a week of completing the curriculum
|
|
Acceptability of the Let's Eat Curriculum
Time Frame: within a week of completing the curriculum
|
Acceptability will be measured through survey items administered after treatment
|
within a week of completing the curriculum
|
|
Nutrition Knowledge - Curriculum Learning Objectives
Time Frame: within a week of completing the curriculum
|
These items will assess the students' nutrition knowledge and familiarity with the learning objectives of the Let's Eat curriculum.
|
within a week of completing the curriculum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Acceptance
Time Frame: at baseline and within a week of completing the curriculum
|
This is a subscale from the FAAT Toolkit that assesses acceptance of one's body.
|
at baseline and within a week of completing the curriculum
|
|
Eating Competence
Time Frame: at baseline and within a week of completing the curriculum
|
This construct will be measured using the Eating Competence 2.0 survey tool.
|
at baseline and within a week of completing the curriculum
|
|
Intuitive Eating
Time Frame: at baseline and within a week of completing the curriculum
|
Three items from the Intuitive Eating Scale - 3 will be used to assess aspects of this construct.
|
at baseline and within a week of completing the curriculum
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jennifer B Webb, PhD, UNC Charlotte
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB-25-0873
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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