Metabolic Testing and Education for Nutritional Awareness

Overseen By Justina Bonsignore

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: PepsiCo Global R&D

Disqualifiers: Pregnancy, School expulsion, others

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

Compensation: Varies

Number of Visits: 2

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have asthma, you are required to bring your prescribed inhaler if you are in the metabolic testing group.

What data supports the effectiveness of the treatment Education, Metabolic Testing for nutritional awareness?

Research shows that educational programs, including computer-assisted and multimedia platforms, can significantly improve knowledge and self-efficacy in managing conditions like diabetes. These findings suggest that similar educational approaches could be effective in increasing nutritional awareness. ^{1 2 3 4 5}

Is Metabolic Testing and Education for Nutritional Awareness safe for humans?

There is no specific safety data available for Metabolic Testing and Education for Nutritional Awareness, but general safety practices in healthcare emphasize the importance of reporting and analyzing adverse events to improve patient safety. ^{6 7 8 9 10}

How does the Metabolic Testing and Education for Nutritional Awareness treatment differ from other treatments?

This treatment is unique because it combines metabolic testing with education to improve nutritional awareness, focusing on personalized dietary management rather than standard drug therapies. It emphasizes understanding individual nutritional needs and enhancing knowledge, which can be more effective for long-term lifestyle changes compared to traditional treatments. ^{1 11 12 13 14}

What is the purpose of this trial?

Many studies have consistently shown that females across sports under consume carbohydrate. Registered dietitians working with athletes have also reported female athletes chronically under consume carbohydrate. The primary objective of this study is to compare the effectiveness of education versus education plus interpreted individual metabolic (exercise) testing results to change attitudes and beliefs of female athletes regarding carbohydrate intake. The secondary objective is to assess the effectiveness of the education alone on attitudes and beliefs towards consuming carbohydrate in female athletes. The study hypothesis is that education alone will not significantly impact attitudes and beliefs, and that metabolic testing and the interpretation of the individual results will alter attitudes and beliefs toward carbohydrate intake.

Research Team

Kris Osterberg, PhD, RD

Principal Investigator

PepsiCo R&D Life Sciences, Sports Science

Eligibility Criteria

This trial is for adolescent female athletes who may not be eating enough carbohydrates. Participants should be interested in learning about their personal metabolism and how it relates to nutrition. There's no specific mention of exclusion criteria, so generally healthy young female athletes are likely eligible.

Inclusion Criteria

I understand the study and can consent, or if under 18, I can get parental consent.

Non-smoker

Currently enrolled in an IMG Academy sport

Exclusion Criteria

Leaving the IMG sports team

Pregnant or planning to become pregnant

Participated in any other clinical trial in the past 30 days

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education

Participants attend a classroom session with slides and videos

2 weeks

1 visit (in-person)

Metabolic Testing

Participants undergo exercise with shared exercise data

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for changes in attitudes and beliefs regarding carbohydrate intake

2 weeks

Treatment Details

Interventions

• Education
• Metabolic Testing

Trial Overview The study is testing if giving metabolic testing results with education changes how these athletes think about carbs compared to just getting educational information. They'll compare the attitudes and beliefs before and after receiving either just education or both education and test results.

Participant Groups

Group I: Education plus metabolic testing Experimental Treatment 2 Interventions

Classroom session with slides and videos. Exercise with shared exercise data.

Group II: Education only Experimental Treatment 1 Intervention

Classroom session with slides and videos.

Who Is Running the Clinical Trial?

PepsiCo Global R&D

Lead Sponsor

Trials

99

Recruited

13,600+

Ramon Laguarta

PepsiCo Global R&D

Chief Executive Officer since 2018

MBA from ESADE Business School

Mark Kirkham

PepsiCo Global R&D

Chief Marketing Officer

Bachelor's degree in Business Administration from Trinity College Dublin

Findings from Research

An interactive computer program significantly improved the knowledge of 41 third-year medical students about nutrition in diabetes care, with posttest scores nearing those of general practice dietitians.

The program also boosted students' self-efficacy in managing diabetes nutrition, demonstrating that computer-assisted education is an effective and efficient way to teach essential nutrition skills in under 30 minutes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-assisted diabetes nutrition education increases knowledge and self-efficacy of medical students. Engel, SS., Crandall, J., Basch, CE., et al.[2018]

A 12-month clinical trial involving 161 patients with type 2 diabetes showed that using a multimedia site for nutritional therapy significantly improved diabetes knowledge and metabolic control, including reductions in HbA1c and waist circumference.

Patients receiving the multimedia education (TN+Nutriluv) had better outcomes compared to those receiving only nutritional therapy, highlighting the effectiveness of combining education with dietary management in improving health indicators for diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education with a multimedia web platform improves knowledge and HbA1c of Mexican patients with type 2 diabetes. Open clinical trial. Reséndiz Lara, T., Muñoz Torres, AV., Mendoza Salmerón, G., et al.[2022]

A five-day education program for 83 diabetic patients significantly improved their knowledge about diabetes management and nutrition, as shown by test scores taken before and one year after the course.

Despite the increase in knowledge, the program did not lead to any significant changes in the patients' metabolic control, indicating that education alone may not be sufficient to improve health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a formalized diabetes education. Karlander, SG., Kindstedt, K.[2019]

A study involving 609 patients at Bern University Hospital found a high prevalence of malnutrition (35%), but an educational intervention for residents did not significantly improve their nutritional knowledge or the number of prescribed nutritional therapies.

Despite the intervention, the percentage of prescribed nutritional therapies remained low and did not show a significant increase, indicating a need for more effective teaching strategies to address malnutrition in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does multifaceted nutritional education improve malnutrition management? Reber, E., Messmer Ivanova, A., Cadisch, P., et al.[2021]

Before education, only 12.5% of malnourished patients were identified by physicians, but after training, 100% of at-risk patients were recognized, demonstrating the effectiveness of a simple screening tool.

The study highlights that physician education on recognizing malnutrition can significantly improve patient care and prevent further nutritional decline during hospital stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Malnutrition among hospitalized patients. A problem of physician awareness. Roubenoff, R., Roubenoff, RA., Preto, J., et al.[2008]

The implementation of the 'Learning from Defects-Tool' (LFD-Tool) has successfully enhanced the competency of clinical nurse specialists in analyzing adverse events, which is crucial for improving patient safety.

Using the LFD-Tool encourages care teams to reflect on adverse events, thereby fostering a stronger safety culture within the hospital setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of adverse events as a contribution to safety culture in the context of practice development Hoffmann, S., Frei, IA.[2019]

Nurses in northern Ghana have an average level of knowledge about adverse medical events (AMEs), with professional nurses being slightly more informed than auxiliary nurses, indicating a need for improved training on AMEs.

Despite a high incidence of AMEs, such as wrongful documentation, many events go unreported, highlighting the necessity for better reporting systems and educational modules in nursing curricula to enhance awareness and compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of frontline nurses with adverse medical events in a regional referral hospital in northern Ghana: a cross-sectional study. Alhassan, RK., Halilu, B., Benin, SM., et al.[2022]

A program aimed at educating registered nurses (RNs) about high reliability showed a positive impact on their willingness to report adverse events, which is crucial for improving patient safety.

Despite the findings not being statistically significant, they highlight the importance of fostering a culture of high reliability in healthcare to encourage more accurate reporting of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of High-Reliability Education on Adverse Event Reporting by Registered Nurses. McFarland, DM., Doucette, JN.[2018]

An internet-based reporting system was developed to help healthcare professionals, particularly pharmacists, report dietary supplement-related adverse events, addressing the issue of underreporting due to lack of awareness and time constraints.

The system not only facilitated the collection of DS-related events but also provided educational resources, which increased engagement and awareness among healthcare professionals regarding the safety of dietary supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Collecting and sharing information about dietary supplements and functional foods among healthcare professionals using internet-based system]. Asahina, Y., Hori, S., Sawada, Y.[2019]

A study involving 335 physicians revealed that their understanding of dietary supplement regulations was inadequate, with an average pretest score of only 59%.

After completing an interactive online educational module, the physicians' knowledge significantly improved, raising their average score to 91%, indicating that such training can enhance awareness and communication about dietary supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physicians' understanding of the regulation of dietary supplements. Ashar, BH., Rice, TN., Sisson, SD.[2022]

A nutritional knowledge test was administered to 2,175 subjects and demonstrated high reliability and validity, effectively distinguishing between different educational and occupational groups.

The test results indicated a significant correlation between nutritional knowledge scores and age, suggesting it could be useful for assessing patients who need dietary management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional knowledge questionnaire. Part two. Abraham, SF., Beumont, PJ., Booth, A., et al.[2021]

In a six-year B.S.-M.D. program, students at the City University of New York integrate nutrition into their chemistry-biochemistry courses by analyzing their own food samples and conducting experiments on rats with similar diets, enhancing their practical understanding of nutrition.

The program combines hands-on nutrition analysis with theoretical learning, allowing students to apply their knowledge in real-world contexts, such as conducting dietary surveys and understanding community health issues they will face as future general practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The integration of nutrition education in the basic biomedical sciences. Raw, I.[2019]

First-year medical students demonstrated knowledge of nutrition that was comparable to the general educated population, but they showed significant gaps in fundamental nutrition concepts, indicating a need for improved nutrition education in medical training.

The study suggests that using questionnaires not only assesses knowledge but also serves as an effective teaching tool, highlighting the importance of focusing on factual nutrition information rather than solely on official guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition education: a questionnaire for assessment and teaching. Makowske, M., Feinman, RD.[2022]

Nursing students demonstrated a moderate level of nutrition knowledge, with an average score of 56.6 out of 100, and about 50.5% of them classified as having good nutrition knowledge.

A high percentage (91.6%) of nursing students showed sufficient nutrition literacy, indicating a strong understanding of nutrition concepts, which positively correlated with their nutrition knowledge scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of nutrition literacy and nutrition knowledge level in nursing students: a study from Turkey. Mengi Çelik, Ö., Semerci, R.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Computer-assisted diabetes nutrition education increases knowledge and self-efficacy of medical students. [2018]

2. Spain pubmed.ncbi.nlm.nih.gov

Education with a multimedia web platform improves knowledge and HbA1c of Mexican patients with type 2 diabetes. Open clinical trial. [2022]

3. Sweden pubmed.ncbi.nlm.nih.gov

Effects of a formalized diabetes education. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Does multifaceted nutritional education improve malnutrition management? [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Malnutrition among hospitalized patients. A problem of physician awareness. [2008]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Analysis of adverse events as a contribution to safety culture in the context of practice development [2019]

7. Japan pubmed.ncbi.nlm.nih.gov

Experiences of frontline nurses with adverse medical events in a regional referral hospital in northern Ghana: a cross-sectional study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Impact of High-Reliability Education on Adverse Event Reporting by Registered Nurses. [2018]

9. Japan pubmed.ncbi.nlm.nih.gov

[Collecting and sharing information about dietary supplements and functional foods among healthcare professionals using internet-based system]. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Physicians' understanding of the regulation of dietary supplements. [2022]

11. Australia pubmed.ncbi.nlm.nih.gov

Nutritional knowledge questionnaire. Part two. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

The integration of nutrition education in the basic biomedical sciences. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Nutrition education: a questionnaire for assessment and teaching. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Evaluation of nutrition literacy and nutrition knowledge level in nursing students: a study from Turkey. [2022]