Hydration Education + Fluid Intake for Dehydration

Overseen By Kris Osterberg, PhD, RD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: PepsiCo Global R&D

Must not be taking: Fluid balance medications

Disqualifiers: Pregnancy, Injury, Illness, others

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

Compensation: Varies

Number of Visits: 6

108 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different hydration strategies affect young athletes who might not drink enough fluids. Researchers aim to determine whether hydration advice or prescribed fluid amounts have a greater impact on maintaining hydration during sports. Participants will either receive no hydration guidance, attend an education session about staying hydrated (Hydration Education), or receive both education and a specific fluid intake plan. The study seeks athletes aged 13-19 who are part of the IMG sports program and are non-smokers. As an unphased trial, this research provides a unique opportunity for young athletes to contribute to understanding effective hydration strategies.

Will I have to stop taking my current medications?

If you are taking any medication that affects fluid balance, you will not be able to participate in the trial.

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

Research has shown that hydration education programs are safe and help individuals drink more water and stay hydrated. Participants often report positive experiences and improved hydration habits.

When combined with specific water intake recommendations, education is also well-received. This approach helps people maintain proper hydration without major side effects.

Overall, evidence suggests that both hydration education alone and with specific water intake guidelines are safe. Participants generally find these methods helpful for enhancing their hydration and well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are enthusiastic about this trial because it explores innovative strategies to combat dehydration through education and structured fluid intake. Unlike typical approaches, which often focus solely on increasing water consumption, this trial includes an educational component that teaches participants about the benefits of proper hydration and how to achieve it effectively. Additionally, one of the experimental arms provides a prescribed hydration routine, offering specific guidance on fluid intake timing and quantity. This dual focus on education and structured hydration could lead to more sustainable, informed hydration habits, potentially improving athletic performance and reducing dehydration risks.

What evidence suggests that this trial's treatments could be effective for dehydration?

Studies have shown that learning about hydration helps people understand the importance of drinking enough water. For example, people who start drinking more water often feel less tired and confused. In this trial, participants in the "Hydration Education between Week 1 and Week 2" arm will receive in-depth education on proper hydration. Research suggests that adding just two extra glasses of water a day can help prevent dehydration. Another arm, "Hydration Education between Week 1 and Week 2 plus Prescribed Hydration Week 2," combines education with a specific hydration plan, which can lead to better hydration habits. This approach has been linked to fewer health problems related to dehydration, such as falls or urinary issues. ^{1 2 3 4 5}

Who Is on the Research Team?

Kris Osterberg, PhD, RD

Principal Investigator

PepsiCo R&D Life Sciences, Sports Science

Are You a Good Fit for This Trial?

This trial is for high school athletes who may not be drinking enough water before practice, as indicated by tests showing they have concentrated urine. The study aims to understand how best to keep these young athletes hydrated, especially in hot environments.

Inclusion Criteria

Currently enrolled in the IMG sports program

I am between 13 and 19 years old.

Parental permission

Exclusion Criteria

I have a condition that affects my ability to play sports or manage body fluids.

Pregnant or planning to become pregnant

Any condition the study investigator believes would interfere with eligibility following the study protocol, affect the study results, or put the subject at undue risk

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Observation

Athletes are observed for three practices per week to establish baseline hydration status

1 week

3 practices (in-person)

Intervention

Participants receive either no intervention, hydration education, or hydration education plus prescribed hydration

1 week

3 practices (in-person)

Follow-up

Participants are monitored for changes in hydration status and body weight

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Hydration Education

Trial Overview The trial is testing two methods: one group will receive education on hydration, while the other group will get both education and a specific amount of water they must drink. The study compares boys and girls across different sports settings to see which method works better.

How Is the Trial Designed?

Group I: Hydration Education between Week 1 and Week 2 plus Prescribed Hydration Week 2 Experimental Treatment 2 Interventions

In-depth education session regarding the effects of dehydration, the performance benefits of proper hydration, and how to properly hydrate before, during, and after activity. Pre-practice urine specific gravity (USG), pre- and post-practice body mass, thirst scale measures. Provided a standard amount of bottled water to drink the evening prior (1 liter) and in the two hours before practice (20 oz). Fluid intake will be recorded in an intake log. Subjects will be permitted to eat or drink whatever they like in addition to the prescribed fluid. Fluid intake during practice (whatever the team is drinking).

Group II: Hydration Education between Week 1 and Week 2 Experimental Treatment 1 Intervention

In-depth education session regarding the effects of dehydration, the performance benefits of proper hydration, and how to properly hydrate before, during, and after activity. Pre-practice urine specific gravity (USG), pre- and post-practice body mass, thirst scale measures. Fluid intake during practice (whatever the team is drinking).

Group III: Control Active Control 1 Intervention

No hydration education or fluid prescription. Pre-practice urine specific gravity (USG), pre- and post-practice body mass, thirst scale measures. Fluid intake during practice (whatever the team is drinking) .

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

Published Research Related to This Trial

Dehydration is a significant issue for older adults, and while the exact risk factors are not clearly defined, it is recommended that they consume at least 1600 mL of fluids per day to stay adequately hydrated.

Monitoring methods such as fluid intake sheets and urine specific gravity can help assess hydration status, and providing regular access to fluids for bedridden individuals is crucial for maintaining hydration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintaining oral hydration in older adults: a systematic review. Hodgkinson, B., Evans, D., Wood, J.[2022]

Dehydration and volume depletion are two different conditions that involve body fluid deficits, each with unique causes, symptoms, and treatment methods.

Misunderstandings about these disorders are common, and the paper suggests strategies to clarify these differences and improve treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dehydration and volume depletion: How to handle the misconceptions. Asim, M., Alkadi, MM., Asim, H., et al.[2020]

Up to 50% of adults do not meet the recommended water intake, which can lead to negative health effects, highlighting the importance of proper hydration education.

The European Healthy Hydration Awareness Campaign (EuHHAC) has successfully increased dietitians' knowledge about hydration through various initiatives, and plans to create an online resource center to further support their practice and improve public health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European Healthy Hydration Awareness Campaign for Dietitians. Belogianni, K., Gandy, J., van Ginkel, A., et al.[2020]

A study evaluating 39 online educational resources about heart failure medications found that most had acceptable quality, with a median score of 61% on the EQIP tool, but only 5% were rated as high quality.

The readability of these resources was generally too high for many patients, with a median grade level of 8, while only 10% met the recommended 6th-grade reading level, which could hinder understanding for those with lower literacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Online Written Medication Educational Resources for People Living With Heart Failure. Ladhar, S., Koshman, SL., Yang, F., et al.[2022]

The study is a randomized controlled trial involving 200 heart failure patients over 12 months, aiming to assess the effectiveness of a multimedia educational intervention in reducing hospital readmissions.

The intervention includes face-to-face education by a specialized nurse, combining a DVD and written materials, and uses a teach-back strategy to ensure patients understand self-management, which may enhance their knowledge and self-care behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Self-care Educational Intervention for Patients With Heart Failure: A Study Protocol. Boyde, M., Peters, R., Hwang, R., et al.[2018]

Improving patient education is crucial for healthcare providers, especially for managing the health of chronically ill patients, as it is a cost-effective strategy.

Successful healthcare organizations should adopt best practices from leading providers to enhance their patient education systems, which can lead to better patient outcomes and organizational success in a competitive environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to improve patient education. Washburn, PV.[2007]

A study involving 61 community nurses revealed significant gaps in their knowledge about heart failure self-management education, with correct responses ranging from 14% to 100% on a 20-item survey.

An educational intervention improved nurses' knowledge, as evidenced by over 90% of them answering more questions correctly after the training, highlighting the need for ongoing education in managing heart failure effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving community health nurses' knowledge of heart failure education principles: a descriptive study. Fowler, S.[2015]

A study involving 100 heart failure patients and 20 healthcare providers revealed that both groups prioritized learning about medications and recognizing worsening symptoms, indicating a shared understanding of critical educational needs.

However, healthcare providers placed significantly more emphasis on diet management compared to patients, highlighting a gap in perceived importance that should be addressed in patient education materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of learning needs priorities between healthcare providers and patients with heart failure. Min, D., Park, JS., Choi, EY., et al.[2020]

Low-intake dehydration is a serious and common issue among older adults, leading to negative health effects such as cognitive decline, reduced quality of life, and increased hospital admissions.

Current methods for assessing dehydration risk are unreliable, and there is a significant need for more research to determine optimal hydration strategies tailored to individual needs and settings for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Narrative Review of Low-Intake Dehydration in Older Adults. Beck, AM., Seemer, J., Knudsen, AW., et al.[2021]

Nurses often lack the knowledge and comfort needed to effectively educate patients about self-care for heart failure, which can lead to poor patient outcomes and increased healthcare use.

Educational interventions that empower patients to manage their heart failure, particularly regarding fluid management, have shown to improve clinical outcomes, highlighting the need for better training and support for nurses in delivering this education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parallel paths to improve heart failure outcomes: evidence matters. Albert, NM.[2013]

In a study of 230 heart failure patients, standard information provided before hospital discharge did not significantly differ in effectiveness from additional education using an interactive CD-ROM, with 52% of the standard group and 49% of the education group reaching the endpoint of readmission or death within 6 months.

Patients who received the interactive education showed improved knowledge about heart failure, suggesting that while the education did not significantly reduce readmission rates, better understanding of the condition may lead to marginally better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an interactive CD-program on 6 months readmission rate in patients with heart failure - a randomised, controlled trial [NCT00311194]. Linné, AB., Liedholm, H.[2018]

Patients with heart failure who received intensive education and care coordination during their hospital stay showed improved self-management skills compared to those receiving usual care, as evidenced by their increased knowledge and health behaviors.

The study involved 40 patients (20 in the intervention group and 20 in the usual care group), and those in the intervention group were more likely to monitor their weight and adopt healthier behaviors, indicating that better education can lead to better self-management of heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot program to improve self-management of patients with heart failure by redesigning care coordination. Shaw, JD., O'Neal, DJ., Siddharthan, K., et al.[2021]

A study involving 34 inpatients with congestive heart failure (CHF) found that patients rated information on medication, cardiovascular anatomy, and treatment as the most important to learn, indicating a clear focus on practical care aspects.

The modified CHF Patient Learning Needs Inventory did not enhance differentiation in patients' information needs, suggesting that simpler methods like rank ordering may be sufficient to assess learning needs effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning needs of patients with congestive heart failure. Chan, AD., Reid, GJ., Farvolden, P., et al.[2022]

In a study of 74 physically active elderly individuals in Portugal, less than 10% were found to be at risk of dehydration, indicating that most participants maintained adequate hydration status.

Food contributed nearly half of the total water intake (47% for women and 48% for men), highlighting the importance of water-rich foods and non-alcoholic beverages in hydration strategies, especially for men who had a significantly higher intake of alcoholic beverages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urinary hydration biomarkers and water sources in free-living elderly. Gonçalves, A., Silva, J., Moreira, P., et al.[2018]

Citations

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Outcomes in Randomized Clinical Trials Testing Changes ... This systematic review summarizes randomized clinical trials that tested the impact of changing participants' daily water intake on a number ...

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Water intake, hydration status and 2-year changes in cognitive ... Reduced physiological hydration status was associated with greater reductions in global cognitive function over a 2-year period in older adults.

5. bmjopen.bmj.com bmjopen.bmj.com/content/6/12/e012004

Hydration education: developing, piloting and evaluating a ... The majority of respondents scored positively towards hydration care, including the need for hydration training for the profession (83%). Personal hydration ...