Diet Education for Healthy Habits

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Oklahoma State University

Disqualifiers: Chronic disease, Special diet, Visual impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different types of foods affect hormones related to hunger and decision-making skills. Participants will follow two diets: one with only ultra-processed foods and another with only unprocessed foods, each for three days. The study seeks adults who can adhere to these diets for a total of six days. This trial could enhance understanding of how diet impacts the body and mind by educating on healthy habits. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research on diet and health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that consuming a lot of ultra-processed foods can harm health. These foods are linked to heart problems, obesity, and mental health issues. For instance, one study found that individuals who consumed the most ultra-processed foods had a 4% higher chance of dying from any cause. Another study reported a 31% higher risk of death over time for those with the highest intake of these foods.

In contrast, unprocessed foods are generally healthier and do not carry the same health risks. Eating unprocessed foods is typically safer and better for overall health.

In summary, while ultra-processed foods are associated with health problems, unprocessed foods are generally a safer choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Diet Education for Healthy Habits" trial because it explores how different types of food—ultra-processed versus unprocessed—affect our health over a short period. Unlike typical dietary guidelines that suggest balanced meals from various food groups, this trial isolates the impact of ultra-processed and unprocessed foods on participants. By focusing on these two extremes, the trial aims to uncover the immediate effects of diet choices that are often debated in nutrition science. Understanding these effects could provide fresh insights into how our food environment influences health, potentially guiding new dietary recommendations.

What evidence suggests that this trial's treatments could be effective for hunger-related hormones and executive function?

This trial will compare the effects of consuming ultra-processed foods versus unprocessed foods. Research has shown that eating many ultra-processed foods can lead to health issues, including heart problems and mental health issues such as anxiety and depression. These foods often lack essential nutrients like protein, fiber, and vitamins. In contrast, studies have found that eating unprocessed foods can increase energy, improve focus, and help prevent diseases like heart disease and diabetes. A diet rich in unprocessed foods may also boost mood and overall well-being. Generally, unprocessed foods are considered healthier than ultra-processed ones. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-55 who are willing to follow a strict diet plan, either entirely ultra-processed or unprocessed, for three days each. It's not suitable for pregnant or breastfeeding individuals, those with chronic diseases affecting participation, anyone on special diets that conflict with the study requirements, or people with uncorrected visual impairments.

Inclusion Criteria

Willing to consume an entirely ultra-processed and entirely unprocessed diet for 3 days each (6 days in total)

Exclusion Criteria

Pregnant or lactating

Special diet that limits adherence to the intervention diets

Visual impairment not corrected by glasses/contacts

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Diet Intervention - Ultra-processed Foods

Participants consume only ultra-processed foods for 3 days

3 days

1 visit (in-person) at baseline, 1 visit (in-person) post-diet

Diet Intervention - Unprocessed Foods

Participants consume only unprocessed foods for 3 days

3 days

1 visit (in-person) post-diet

Follow-up

Participants are monitored for changes in hunger-related hormones and executive function

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Education

Trial Overview The study is testing how an ultra-processed food diet versus an unprocessed food diet affects hunger-related hormones and the ability to perform certain mental tasks. Participants will be randomly assigned to one of two groups in a crossover design meaning they'll try both diets.

How Is the Trial Designed?

Group I: Unprocessed foods Experimental Treatment 1 Intervention

Participants are instructed to consume only unprocessed foods for 3 days.

Group II: Ultra-processed foods Experimental Treatment 1 Intervention

Participants are instructed to consume only ultra-processed foods for 3 days.

Who Is Running the Clinical Trial?

Oklahoma State University

Lead Sponsor

Trials

51

Recruited

8,600+

Published Research Related to This Trial

Diet significantly influences health, cognitive performance, and psychological well-being, but simply providing information about healthy eating is often not enough to change dietary behaviors.

Successful dietary interventions must combine nutrition education with behavioral psychology strategies, such as self-monitoring and coping skills, to effectively promote and maintain dietary changes across different populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to dietary regimens. 2: Components of effective interventions. Brownell, KD., Cohen, LR.[2016]

Therapeutic education significantly improves patients' quality of life and treatment compliance, leading to remarkable outcomes such as an 80% reduction in amputations over 10 years for diabetic patients.

Motivational interviewing techniques are crucial in helping patients change their behaviors gradually, making them active partners in their treatment and enhancing their ability to manage their health effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic education of the diabetic patient]. Golay, A., Lagger, G., Chambouleyron, M., et al.[2015]

Nutrition education is most effective when tailored to the specific circumstances and needs of the target audience, highlighting the importance of understanding the learners' context.

Continuous evaluation and adaptation of educational methods are crucial for improving the effectiveness of nutrition education programs, as indicated by insights from 16 recent evaluation reports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition education for changes. Angove, R.[2016]

Nutrition interventions among college students can effectively promote positive dietary changes, which may help in managing weight and reducing the risk of obesity, as shown in a systematic review of 30 studies published between 2000 and 2015.

However, many studies lacked comparison groups and long-term follow-up, making it difficult to determine if the dietary changes were directly caused by the interventions or if they were sustained over time; future research should address these methodological issues to enhance the effectiveness of such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the effectiveness of nutrition interventions implemented among US college students to promote healthy behaviors: A systematic review. Brace, AM., De Andrade, FC., Finkelstein, B.[2019]

Setting specific goals in nutrition education significantly enhances its effectiveness, as identified through the validation of 24 key objectives for professionals in the field.

These validated objectives can help teachers, dietitians, and nutritionists tailor their approaches to better influence behavior change among various groups, including students and clients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation and application of nutrition education objectives. Briley, ME., Sullivan, S., Stevenson, S., et al.[2015]

A study involving 31 individuals with serious mental illnesses found that most participants understood healthy eating as consuming fruits and vegetables while avoiding junk food, but faced significant internal barriers like negative perceptions and comfort eating.

External barriers such as limited access to healthy foods and the effects of psychiatric medications also hindered healthy eating, suggesting that targeted interventions and education could help improve dietary habits and reduce cardiovascular disease risk in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy eating in persons with serious mental illnesses: understanding and barriers. Barre, LK., Ferron, JC., Davis, KE., et al.[2016]

Individualized diet therapy is crucial for cancer patients, emphasizing the need for tailored dietary plans based on individual assessments and periodic reassessments.

Education for cancer patients should include information on side effects and various preventive and therapeutic measures, recognizing that what works for one patient may not work for another, thus providing multiple alternatives for each issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The nurse's role in nutritional management of radiotherapy patients. Schreier, AM., Lavenia, J.[2008]

A three-week educational program for schizophrenic patients significantly increased their knowledge about schizophrenia and its treatment, indicating that patients can learn and retain important information about their condition.

The educational program also led to a significant decrease in negative symptoms of schizophrenia, suggesting that education can improve functioning in severely psychiatrically ill patients, although it did not affect positive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a patient education program in the treatment of schizophrenia. Goldman, CR., Quinn, FL.[2019]

A course on societal issues related to food, called Food and Society, significantly improved healthful eating behaviors among 28 college students, particularly increasing vegetable intake and decreasing high-fat dairy consumption compared to a control group of 72 students.

The innovative approach of discussing environmental, ethical, and cultural themes in food education appears effective in promoting healthier dietary choices, suggesting that focusing on broader societal contexts can enhance traditional health education programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a college course about food and society on students' eating behaviors. Hekler, EB., Gardner, CD., Robinson, TN.[2020]

Health education plays a crucial role in health promotion by focusing on voluntary learning about health and illness, but it has faced criticism for being overly focused on disease and potentially increasing health inequalities.

Despite past criticisms regarding its effectiveness, there is evidence that some health education interventions work, and the paper argues for a renewed emphasis on its importance in current health strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health education: a case for resuscitation. Kemm, J.[2004]

A quality improvement project involving 124 psychiatric patients showed that individualized safety plans created during inpatient treatment were well-tailored, scoring an average of 32.85 out of 44 on a customization rubric.

Postdischarge, 96.1% of patients retained their safety plans, and 36.8% reported using them, with 67.9% of those users finding the plans helpful, indicating that these plans can support recovery after hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the Gap Between Individualized Inpatient Safety Planning and Postdischarge Efficacy. Leonard, J., Chiappetta, L., Stark, S., et al.[2023]

Therapeutic patient education has been shown to be effective in improving treatment outcomes for chronic patients, with over 500 studies analyzed, demonstrating efficacy in 60% of cases across various diseases.

In the case of obesity, therapeutic education led to significant and lasting weight loss, indicating its potential as a valuable intervention for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficiency of therapeutic education]. Lagger, G., Pataky, Z., Golay, A.[2019]

Visualized nutrition education significantly improved dietary knowledge and behaviors, leading to increased fiber intake in both short-term and long-term assessments, with a total of 7,259 participants analyzed across 14 studies.

The effectiveness of visualized education was enhanced when delivered in a series, was culturally adapted, and avoided loss-framing, suggesting that these factors can optimize the impact of nutrition education on dietary habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visualized nutrition education and dietary behavioral change: A systematic review and meta-analysis. Li, X., Huang, Y., Yin, R., et al.[2019]

Patient education significantly improves compliance with therapeutic regimens in chronic disease management, with an average improvement of 0.67 sigma over control groups, indicating a strong effect.

While patient education also leads to improvements in physiological progress (0.49 sigma) and health outcomes (0.02 sigma), the most effective strategies involve behaviorally-oriented programs that focus on changing the patient's environment rather than just increasing knowledge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does patient education in chronic disease have therapeutic value? Mazzuca, SA.[2019]

Citations

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Ultra-processed food exposure and adverse health outcomes Greater exposure to ultra-processed food was associated with a higher risk of adverse health outcomes, especially cardiometabolic, common mental disorder, and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11625872/

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Nutrition Fact Check: Ultra-Processed Foods Data from the 2009-2010 National Health and Nutrition Examination Survey (NHANES) reported a decrease in average intake of protein, fiber, vitamins A, C, D and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2667368125000476

The impact of ultra-processed foods on pediatric health Some studies show that high-UPF diets promote the occurrence and worsening of anxiety, depression, and attention-deficit hyperactivity disorder (ADHD) [56].

5. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1421728/full

Ultra-processed foods consumption and health-related ... Prospective observational studies have reported significant associations between higher intake of UPFs and adverse health outcomes.

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Ultra-Processed Foods and Health Outcomes: A Narrative ... 37 found dietary UPF exposure associated with at least one adverse health outcome. Among adults, these included overweight, obesity and cardio-metabolic risks.

7. hsph.harvard.edu hsph.harvard.edu/news/ultra-processed-foods-some-more-than-others-linked-to-early-death/

Ultra-processed foods—some more than others—linked to ... The study found that participants who ate the most ultra-processed food of any kind faced a 4% higher risk of all-cause mortality, as well as an ...

8. ama-assn.org ama-assn.org/public-health/prevention-wellness/what-doctors-wish-patients-knew-about-ultraprocessed-foods

What doctors wish patients knew about ultraprocessed foods A large study conducted over 19 years showed a 31% higher mortality for the highest versus lowest consumers of ultraprocessed foods,” Dr. Devries explained. “ ...

9. usda.gov usda.gov/about-usda/news/press-releases/2025/07/23/hhs-fda-and-usda-address-health-risks-ultra-processed-foods

HHS, FDA and USDA Address the Health Risks of Ultra- ... Dozens of scientific studies have found links between the consumption of foods often considered ultra-processed with numerous adverse health ...