NCT06449963

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
21 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 18, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

June 4, 2024

Last Update Submit

April 17, 2025

Conditions

Keywords

Health Belief ModelElderlyHydrationEducation Program

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    At baseline, after 15 days, and on day 30

Study Arms (2)

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.

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.

Interventions

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.

Health Belief Model Education Group

Eligibility Criteria

Age65 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged 65 years and older. Consuming less than 1000 ml of water daily.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University Health Sciences Institute, Department of Nursing Principles

Erzurum, 25000, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 37121897BACKGROUND

Related Links

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
There are no additional masked parties in this clinical trial.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate (Doctoral Student)

Study Record Dates

First Submitted

June 4, 2024

First Posted

June 10, 2024

Study Start

July 1, 2024

Primary Completion

December 31, 2024

Study Completion

December 1, 2025

Last Updated

April 18, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

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/

Available IPD Datasets

Data not yet available Access

Locations