60 Participants Needed

Metabolic Testing and Education for Nutritional Awareness

KO
JB
Overseen ByJustina Bonsignore
Age: < 65
Sex: Female
Trial Phase: Academic
Sponsor: PepsiCo Global R&D
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

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.111121314

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

KO

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
See 5 more

Exclusion Criteria

Leaving the IMG sports team
Pregnant or planning to become pregnant
Participated in any other clinical trial in the past 30 days
See 3 more

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
2Treatment groups
Experimental Treatment
Group I: Education plus metabolic testingExperimental Treatment2 Interventions
Classroom session with slides and videos. Exercise with shared exercise data.
Group II: Education onlyExperimental Treatment1 Intervention
Classroom session with slides and videos.

Find a Clinic Near You

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

References

Computer-assisted diabetes nutrition education increases knowledge and self-efficacy of medical students. [2018]
Education with a multimedia web platform improves knowledge and HbA1c of Mexican patients with type 2 diabetes. Open clinical trial. [2022]
Effects of a formalized diabetes education. [2019]
Does multifaceted nutritional education improve malnutrition management? [2021]
Malnutrition among hospitalized patients. A problem of physician awareness. [2008]
Analysis of adverse events as a contribution to safety culture in the context of practice development [2019]
Experiences of frontline nurses with adverse medical events in a regional referral hospital in northern Ghana: a cross-sectional study. [2022]
Impact of High-Reliability Education on Adverse Event Reporting by Registered Nurses. [2018]
[Collecting and sharing information about dietary supplements and functional foods among healthcare professionals using internet-based system]. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Physicians' understanding of the regulation of dietary supplements. [2022]
Nutritional knowledge questionnaire. Part two. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
The integration of nutrition education in the basic biomedical sciences. [2019]
Nutrition education: a questionnaire for assessment and teaching. [2022]
Evaluation of nutrition literacy and nutrition knowledge level in nursing students: a study from Turkey. [2022]
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