- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06449963
Effect of Health Belief Model Education on Water Intake in the Elderly (HBM-Water Study) (HBM-Water Stud)
The Effect of Health Belief Model-Based Education on Daily Water Consumption and Dehydration Symptoms in Elderly Individuals Who Do Not Drink Enough Water
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Erzurum, Turkey, 25000
- Atatürk University Health Sciences Institute, Department of Nursing Principles
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Aged 65 years and older. Consuming less than 1000 ml of water daily.
Exclusion Criteria:
Scoring below 17 on the Mini-Mental State Examination. Being bedridden. Having a medical condition that requires fluid restriction. Taking diuretic medications.
Withdrawal Criteria:
Elderly participants who wish to withdraw from the study at any stage of the research process.
Participants who meet the exclusion criteria during the study period.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Health Belief Model Education Group
Participants in this arm will receive a structured educational program aimed at increasing their daily water intake. The program is based on the principles of the Health Belief Model (HBM) and includes the following components: Educational Sessions: Weekly group sessions led by trained health educators, focusing on the importance of hydration, the benefits of adequate water intake, and strategies to incorporate more water into daily routines. Behavioral Strategies: Practical tips and techniques to overcome barriers to water intake, such as setting daily water goals, using water bottles, and incorporating water-rich foods into the diet. Personalized Feedback: Individualized feedback and support provided through weekly one-on-one meetings with a health coach to track progress and address any challenges. Educational Materials: Distribution of printed and digital materials, including pamphlets and interactive tools, to reinforce learning and support behavior change. |
Participants in this group will receive a structured training program with the aim of increasing daily water consumption and reducing symptoms of dehydration. The program is based on the principles of the Health Belief Model and includes the following components: Initial and mid-Program training: Will be conducted by a trained health educator, each lasting 60 minutes. Two weeks after the first training, the same training will be given again for reinforcement purposes. Session Content: Covers the importance of hydration, strategies to increase water intake (using reminders, setting goals, integrating water-rich foods), and the health benefits of adequate hydration (e.g., improved cognitive function, better physical health). Training Materials: Booklet prepared for training. Behavioral Strategies: Practical tips for overcoming barriers to drinking more water, such as setting daily water intake goals and using diaries to track progress. |
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No Intervention: No Education Control Group
Participants in this arm will not receive any specific education or intervention and will follow their usual routines.
This group will serve as a control to compare the effectiveness of the Health Belief Model-based education program administered to the intervention group.
The daily water intake of participants in this group will be recorded using standardized intake diaries, and averages will be calculated weekly.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Average Daily Water Intake (liters)
Time Frame: Data collection at baseline, 24-hour intervals, and daily data collection until the end of 30 days
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In order to determine the effect of providing health belief model education on the level of water consumption; The daily water consumption amount is determined before training.
After the training, they are asked to record the amount of water they will consume daily for 30 days on the record chart.
Then, the amount of water consumed at 3-day intervals is called and recorded by the patient.
The amount of change in daily water consumption at the end of 30 days will determine the effect level of the training.
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Data collection at baseline, 24-hour intervals, and daily data collection until the end of 30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Hydration Status (urine specific gravity)
Time Frame: At baseline, after 15 days, and on day 30
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In order to determine the effect of providing health belief model education on the change in hydration status; Before training, the specific gravity of the urine is measured using a refractometer.
The same measurement is repeated 15 days later, after reinforcement training, and on the 30th day of the study.
In this way, the effect of training on the change in hydration status will be determined.
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At baseline, after 15 days, and on day 30
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATAUNI-NURS-FON-2024
- ATAUNI-BAPSIS-TDK-2024-13931 (Other Grant/Funding Number: Atatürk University Scientific Research Projects (BAP) Support)
- BAYBU-IRB-2024-14 (Other Identifier: Bayburt University Non-invasive Clinical Research Ethics Committee Approval, dated 23.02.2024, Decision Number 2024/14)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
When I answered yes, the system accepted the URL I gave as incorrect, so I chose the no option to continue.
Time Frame: "IPD and supporting information will be available for 3 years, starting 6 months after the article is published."
Access Criteria: "Researchers who present a methodologically sound proposal will have access to the IPD and supporting information. To gain access to the data, those requesting data will be required to sign a data access agreement. Suggestions should be directed to [arzucimen@bayburt.edu.tr]." https://www.atauni.edu.tr/
Study Data/Documents
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Data not yet available
Information comments: Data and supporting information will be made available 6 months after the study completion. For access, researchers need to submit a methodologically sound proposal and sign a data access agreement.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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