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Eating Disorders in ChildrenNCT07615088

Feasibility and Acceptability of the BE REAL Let's Eat Curriculum in Middle Schoolers

A study testing Let's Eat Nutrition Curriculum in people with Eating Disorders in Children, run by University of North Carolina, Charlotte at 2 sites 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 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. Read more about this study

Who is it for?
Ages 11 to 14 yearsHealthy volunteers can take part
Conditions the study is for
Eating Disorders in Children
What is being tested?
Let's Eat Nutrition Curriculum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
2 sitesUnited States
Study dates
6 Feb 2026to 15 Mar 2026
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 11 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Kellogg Middle School

    Portland, Oregon, 97206

  • West Sylvan Middle School

    Portland, Oregon, 97225

Other trials in United States

About this study

Official title: Be Real's 'Let's Eat' Middle School Curriculum: A Feasibility and Acceptability Pilot Study

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.

Read the 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).

Being tested
Let's Eat Nutrition Curriculum
Keywords
nutrition curriculum, middle school, eating disorder prevention, eating competence, intuitive eating

What participants receive

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

  • Let's Eat Nutrition CurriculumBehavioural

    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.

Study groups in NCT07615088
Study groupRoleWhat they receive
Let's Eat Nutrition CurriculumExperimentalStudents 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.
Receives: Behavioral: Let's Eat Nutrition Curriculum

What is being measured

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

  1. Feasibility of Implementing the Let's Eat 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

    Measured: from baseline to within a week of completing the curriculum

  2. Acceptability of the Let's Eat Curriculum

    Acceptability will be measured through survey items administered after treatment

    Measured: within a week of completing the curriculum

  3. Nutrition Knowledge - Curriculum Learning Objectives

    These items will assess the students' nutrition knowledge and familiarity with the learning objectives of the Let's Eat curriculum.

    Measured: within a week of completing the curriculum

Secondary outcomes (3)
  1. Body Acceptance

    This is a subscale from the FAAT Toolkit that assesses acceptance of one's body.

    Measured: at baseline and within a week of completing the curriculum

  2. Eating Competence

    This construct will be measured using the Eating Competence 2.0 survey tool.

    Measured: at baseline and within a week of completing the curriculum

  3. Intuitive Eating

    Three items from the Intuitive Eating Scale - 3 will be used to assess aspects of this construct.

    Measured: at baseline and within a week of completing the curriculum

Timeline

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

  1. First posted29 May 2026
  2. Study start6 Feb 2026
  3. Primary completion15 Mar 2026
  4. Study completion15 Mar 2026

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Middle schoolers will be recruited from two partnering schools within the Portland Public School district. However, there will not be a control group. Students at both schools will receive the Let's Eat nutrition curriculum for this early-phase feasibility trial.
Masking
None (open label)
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07615088
Sponsor's protocol ID
IRB-25-0873
Status last verified
May 2026
First submitted
22 Feb 2026
Last updated
29 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After obtaining the approval of the UNC Charlotte IRB and the Portland Public School district's Research and Evaluation Office, we would make available a de-identified version of the data set to interested researchers for analytic purposes.

Questions about this trial

What is this clinical trial studying?

A study testing Let's Eat Nutrition Curriculum in people with Eating Disorders in Children, run by University of North Carolina, Charlotte at 2 sites 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 3 inclusion and 4 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 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Feasibility of Implementing the Let's Eat Curriculum (time frame: from baseline to within a week of completing the curriculum). The study lists 3 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 29 May 2026.

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