DehydrationHBM-Water StudNCT06449963
Effect of Health Belief Model Education on Water Intake in the Elderly (HBM-Water Study)
A study testing Health Belief Model Education in people with Dehydration and Water Consumption in Elderly, run by Bayburt University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate the effectiveness of a Health Belief Model (HBM)-based education program to increase daily water consumption among elderly individuals aged 65 and above. Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Dehydration, Water Consumption in Elderly
- What is being tested?
- Health Belief Model Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 years and older. Consuming less than 1000 ml of water daily.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk University Health Sciences Institute, Department of Nursing Principles
Erzurum, 25000
About this study
Official title: The Effect of Health Belief Model-Based Education on Daily Water Consumption and Dehydration Symptoms in Elderly Individuals Who Do Not Drink Enough Water
The purpose of this study is to evaluate the effectiveness of a Health Belief Model (HBM)-based education program to increase daily water consumption among elderly individuals aged 65 and above. Participants will be divided into two groups; one group will receive HBM-based education, and the other group will not receive any education. The effects of the education program on daily water consumption and dehydration symptoms will be assessed.
Read the detailed description
The study has a randomized controlled design and will last 1 month. The study group will be given a Health Belief Model (HBM)-based training program for 1 month, and the same training will be given again after 2 weeks to reinforce the training, while the control group will not receive any training. Participants; Daily water consumption will be collected and dehydration symptoms will be evaluated at baseline and at the end of 1 month, and differences between groups will be analyzed.
- Conditions
- Dehydration, Water Consumption in Elderly
- Being tested
- Health Belief Model Education
- Keywords
- Health Belief Model, Elderly, Hydration, Education Program
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Belief Model EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Health Belief Model Education Group | Experimental | 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. Receives: Behavioral: Health Belief Model Education |
| No Education Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Average Daily Water Intake (liters)
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.
Measured: Data collection at baseline, 24-hour intervals, and daily data collection until the end of 30 days
Secondary outcomes (1)
Change in Hydration Status (urine specific gravity)
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.
Measured: At baseline, after 15 days, and on day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Jul 2024
- Primary completion31 Dec 2024
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DehydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel assignment model where participants are randomly assigned to either the intervention group or the control group. The intervention group will receive the Health Belief Model (HBM)-based education program, while the control group will receive no education. The purpose is to compare the effectiveness of the HBM-based education program on increasing daily water consumption among elderly individuals.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayburt University
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Principal investigator, Arzu ÇİMEN, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449963
- Sponsor's protocol ID
- ATAUNI-NURS-FON-2024
- Other IDs
- ATAUNI-BAPSIS-TDK-2024-13931, BAYBU-IRB-2024-14
- Acronym
- HBM-Water Stud
- Status last verified
- Apr 2025
- First submitted
- 4 Jun 2024
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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/
Publications
Ciftci B, Yildiz GN, Avsar G, Kose S, Aydin E, Dogan S, Celik S. Development of the Thirst Discomfort Scale: A Validity and Reliability Study. Am J Crit Care. 2023 May 1;32(3):176-183. doi: 10.4037/ajcc2023954.
PubMed 37121897
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Belief Model-Based Education on Daily Water Consumption and Dehydration Symptoms in Elderly Individuals Who Do Not Drink Enough Water
- ClinicalTrials.gov ID
- NCT06449963
- Acronym / sponsor ID
- HBM-Water Stud / ATAUNI-NURS-FON-2024
- Conditions
- Dehydration, Water Consumption in Elderly
- Keywords
- Health Belief Model, Elderly, Hydration, Education Program
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Bayburt UniversityUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of a Health Belief Model (HBM)-based education program to increase daily water consumption among elderly individuals aged 65 and above. Participants will be divided into two groups; one group will receive HBM-based education, and the other group will not receive any education. The effects of the education program on daily water consumption and dehydration symptoms will be assessed.
Detailed description
The study has a randomized controlled design and will last 1 month. The study group will be given a Health Belief Model (HBM)-based training program for 1 month, and the same training will be given again after 2 weeks to reinforce the training, while the control group will not receive any training. Participants; Daily water consumption will be collected and dehydration symptoms will be evaluated at baseline and at the end of 1 month, and differences between groups will be analyzed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a parallel assignment model where participants are randomly assigned to either the intervention group or the control group. The intervention group will receive the Health Belief Model (HBM)-based education program, while the control group will receive no education. The purpose is to compare the effectiveness of the HBM-based education program on increasing daily water consumption among elderly individuals.
| Arm | Type | Receives |
|---|---|---|
| Health Belief Model Education Group | Experimental | Behavioral: Health Belief Model EducationParticipants 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. |
| No Education Control Group | No intervention | –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. |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Aged 65 years and older. Consuming less than 1000 ml of water daily.
Key exclusion criteria (4 listed)
- Scoring below 17 on the Mini-Mental State Examination. Being bedridden. Having a medical condition that requires fluid restriction. Taking diuretic medications.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Belief Model EducationParticipants 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. | Behavioural | Health Belief Model Education Group |
Primary outcome
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
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.
1 secondary outcome
Change in Hydration Status (urine specific gravity)
Time frame: At baseline, after 15 days, and on day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Background: PubMed 37121897Ciftci B, Yildiz GN, Avsar G, Kose S, Aydin E, Dogan S, Celik S. Development of the Thirst Discomfort Scale: A Validity and Reliability Study. Am J Crit Care. 2023 May 1;32(3):176-183. doi: 10.4037/ajcc2023954.
- Development of the Thirst Discomfort Scale: A Validity and Reliability StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Belief Model Education in people with Dehydration and Water Consumption in Elderly, run by Bayburt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06449963, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.