DementiaNCT06739642
Effectiveness of Dementia Nutrition Education
A study testing Education in people with Dementia and Nutrition, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial summary
Nutritional problems can and do manifest themselves at various stages and with varying degrees of severity. Patients with dementia are at significant risk for weight loss and malnutrition due to the numerous issues that arise during the disease process. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Nutrition, Nutrition Deficiency Due to Insufficient Food
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2020to 25 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being a primary caregiver,
- aged> 18,
- volunteering to participate in the study.
- Exclusion criteria for caregivers -wanting to quit working, not attending training
- According to DSM-V criteria, they must have a nutritional disorder, metabolic disorder, or dementia that is not due to systematic diseases
- be fed orally
- have the caregiver/guardian of the patient with dementia voluntarily agree to participate in the research with him/herself and the patient
Who cannot join
- -Having a health condition that affects nutrition
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Manisa Celal Bayar University
Manisa, YUNUSEMRE, 4500
About this study
Official title: Effectiveness of Caregiver Nutrition Education on the Diet of Patient with Dementia: a Randomized Controlled Trial
Nutritional problems can and do manifest themselves at various stages and with varying degrees of severity. Patients with dementia are at significant risk for weight loss and malnutrition due to the numerous issues that arise during the disease process. Caregivers of patients with dementia face significant challenges in providing nutritional care for their patients due to difficulties with nutrition for physical, emotional, cognitive, and behavioral reasons.
The following methods were used: This study employed a randomized controlled trial with a pretest-posttest design. The study was conducted with 89 patients and caregivers (45 in the intervention group and 44 in the control group). We collected data from the intervention and control groups before and after the intervention using the Descriptive Information Form, Edinburgh Nutrition Evaluation in Dementia (EdFED) Scale, Mini Nutritional Assessment, Dysphagia Assessment Scale in Multiple Sclerosis, and Sarcopenia Screening Test (SARC-F). The intervention group received a standardized educational program for three months. We evaluated the data using percentages, arithmetic means, standard deviations, medians, and interquartile ranges. We analyzed the data using chi-square tests, Mann-Whitney U tests, Wilcoxon signed-rank tests, and intention-to-treat analyses.
- Being tested
- Education
- Keywords
- Dementia, Caregiving, Nutrition and Feeding Issues, Education and Training, Nursing.
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
caregivers in the intervention group received an individualized educational program intervention. The content of the educational program was developed by the researcher through a review of the literature and interviews with caregivers. The educational program, during three months, was delivered in 6 sessions of 40 minutes each. The topics of the training content were as follows: 1. General Nutrition Information, 2. Changes Affecting Nutrition During Old Age and Nutrition Principles, 3. Anthropometric Measurements and Scans, 4. Nutritional Problems in the Patient with Dementia, Dementiamendations for Increasing Nutritional Intake in Dementia Patients, 6. Alternatives for Severe Feeding Problems. Covering general topics was held as group education; carried out in two separate groups. Another individual session was planned for caregivers who could not attend the group education program, and the missing topics were completed.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | caregivers in the intervention group (n=45) received an individualized educational program intervention Receives: Other: Education |
| Control | No intervention | Caregivers in the control group (n=44) continued to receive routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Edinburgh Nutrition Assessment in Dementia ( EdFED ) Scale
The Edinburgh Nutrition Assessment in Dementia ( EdFED ) Scale developed by Watson (Watson, 1994)helps screen for feeding difficulties in patients with dementia. The scale establishes the behavioural baseline and defines the level of assistance the patient needs. Administration of the scale takes less than five minutes. The first 10 items in the scale address feeding behaviour at meals; Depending on how often each behavior occurs during a feeding, 0 points are given for "never", 1 point is given if it occurs 2 or 3 times a week / "sometimes", and 2 points are given if it occurs more than 4 times a week / " often". The score from the first 10 items ranges from 0 to 20, with 20 being the most serious condition. Points can be used to track change. Finally, item 11 states the level of support the patient needs. The scale was reported to be valid and reliable (Cronbach Alpha coefficient = 0.86) (Uyar et al., 2022). In this study, the Cronbach Alpha coefficient was found to be 0.90 in
Measured: Four months
Dysphagia Assessment Scale in Multiple Sclerosis (DYMUS)
Dysphagia Assessment Scale in Multiple Sclerosis (DYMUS) was developed by Bergamaschi et al. (2008) for the evaluation of oropharyngeal dysphagia in patients with Multiple Sclerosis (Bergamaschi et al., 2008). In the scale, the dysphagia score for solids is calculated by adding the 1st, 3rd, 4th, 5th, 7th, 8th and 10th items, and the dysphagia score for liquids is calculated by adding the 2nd, 6th and 9th items. Scale items are coded as "No = 0" and "Yes = 1". Scores between 0 and 10 can be obtained from the scale. A score of 1 or above indicates the presence of dysphagia, and a score of 3 or more indicates the presence of severe dysphagia. Turkish validity and reliability study was conducted by Tenekeci et al. and it has been reported that the total scale of Cronbach's Alpha coefficient has been 0.91 (Tenekeci et al., 2018). In this study, the Cronbach Alpha coefficient was in the pre-test 0.85; it was in the post-test 0.86. Although the scale was developed for patients with MS, app
Measured: Four months
The Mini Nutritional Assessment (MND) Test
The Mini Nutritional Assessment (MND) Test was developed in 1994 in collaboration between the University of TOULOUSE, New Mexico Medical School and Nestle Research Center (Switzerland). MND is widely used in community clinical practice to examine the nutritional status of the elderly and dementia patients. The test consists of 18 items covering anthropometric measurements, dietary behaviours, and global and subjective factors. Malnutrition Indicator Score (MGP) is calculated by summing the preliminary evaluation score and the comprehensive evaluation score. Malnutrition Indicator Score (MGP) can be at least 0 and at most 30. The range of 24-30 points indicates no risk of malnutrition, the range of 17-23.5 points indicates the risk of malnutrition, and scores less than 17 indicate the presence of malnutrition. Mini Nutritional Assessment (MND) is a common screening tool (Guigoz, 2006). Cronbach's alpha coefficient was reported as 0.65 in elderly people with early-stage dementia (Holm \&
Measured: Four months
The Sarcopenia Screening Test (SARC-F)
The Sarcopenia Screening Test (SARC-F) was developed as a possible rapid diagnostic test for (Malmstrom \& Morley, 2013) questions the individual's assistance needed for weight bearing, walking, getting up from a chair/bed, climbing stairs, and the experience of falling. Scores range from 0 to 10, with 0-2 points for each component. The 0-3 points range represents healthy, and 4 points and above represent sarcopenia and poor outcomes. Its suitability for the geriatric population in Turkey was checked by Kış and Karaca (2021) (Cronbach Alpha coefficient = 0.60) (Kış \& Karaca, 2021). In this study, the Cronbach Alpha coefficient was in the pre-test 0.79; it was in the post-test 0.76.
Measured: Four months
BMI
In this study, BMI was used to evaluate the nutritional status of the patient with dementia. In a similar study (Salva et al., 2011) in the literature on the nutrition of dementia patients, weight was monitored by mail. Care was taken to ensure that the measurements were made by the instructions and by the same person.
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start15 Jan 2020
- Primary completion15 Dec 2022
- Study completion25 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Uyar Açışlı, Manisa Celal Bayar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739642
- Sponsor's protocol ID
- CBU-NURS-FUA-01
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data may be shared with individual researchers upon request after the study has been completed and published; however, for data security reasons, sharing the data before publication is not being considered.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Caregiver Nutrition Education on the Diet of Patient with Dementia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06739642
- Acronym / sponsor ID
- CBU-NURS-FUA-01
- Keywords
- Dementia, Caregiving, Nutrition and Feeding Issues, Education and Training, Nursing.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 25 Dec 2022 (actual)
- First posted
- 18 Dec 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.
Nutritional problems can and do manifest themselves at various stages and with varying degrees of severity. Patients with dementia are at significant risk for weight loss and malnutrition due to the numerous issues that arise during the disease process. Caregivers of patients with dementia face significant challenges in providing nutritional care for their patients due to difficulties with nutrition for physical, emotional, cognitive, and behavioral reasons.
The following methods were used: This study employed a randomized controlled trial with a pretest-posttest design. The study was conducted with 89 patients and caregivers (45 in the intervention group and 44 in the control group). We collected data from the intervention and control groups before and after the intervention using the Descriptive Information Form, Edinburgh Nutrition Evaluation in Dementia (EdFED) Scale, Mini Nutritional Assessment, Dysphagia Assessment Scale in Multiple Sclerosis, and Sarcopenia Screening Test (SARC-F). The intervention group received a standardized educational program for three months. We evaluated the data using percentages, arithmetic means, standard deviations, medians, and interquartile ranges. We analyzed the data using chi-square tests, Mann-Whitney U tests, Wilcoxon signed-rank tests, and intention-to-treat analyses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Educationcaregivers in the intervention group (n=45) received an individualized educational program intervention |
| Control | No intervention | –Caregivers in the control group (n=44) continued to receive routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- being a primary caregiver,
- aged> 18,
- volunteering to participate in the study.
- Exclusion criteria for caregivers -wanting to quit working, not attending training
- According to DSM-V criteria, they must have a nutritional disorder, metabolic disorder, or dementia that is not due to systematic diseases
Key exclusion criteria (1 listed)
- -Having a health condition that affects nutrition
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 |
|---|---|---|
| Educationcaregivers in the intervention group received an individualized educational program intervention. The content of the educational program was developed by the researcher through a review of the literature and interviews with caregivers. The educational program, during three months, was delivered in 6 sessions of 40 minutes each. The topics of the training content were as follows: 1. General Nutrition Information, 2. Changes Affecting Nutrition During Old Age and Nutrition Principles, 3. Anthropometric Measurements and Scans, 4. Nutritional Problems in the Patient with Dementia, Dementiamendations for Increasing Nutritional Intake in Dementia Patients, 6. Alternatives for Severe Feeding Problems. Covering general topics was held as group education; carried out in two separate groups. Another individual session was planned for caregivers who could not attend the group education program, and the missing topics were completed. | Other | Intervention |
Primary outcome
The Edinburgh Nutrition Assessment in Dementia ( EdFED ) Scale
Time frame: Four months
The Edinburgh Nutrition Assessment in Dementia ( EdFED ) Scale developed by Watson (Watson, 1994)helps screen for feeding difficulties in patients with dementia. The scale establishes the behavioural baseline and defines the level of assistance the patient needs. Administration of the scale takes less than five minutes. The first 10 items in the scale address feeding behaviour at meals; Depending on how often each behavior occurs during a feeding, 0 points are given for "never", 1 point is given if it occurs 2 or 3 times a week / "sometimes", and 2 points are given if it occurs more than 4 times a week / " often". The score from the first 10 items ranges from 0 to 20, with 20 being the most serious condition. Points can be used to track change. Finally, item 11 states the level of support the patient needs. The scale was reported to be valid and reliable (Cronbach Alpha coefficient = 0.86) (Uyar et al., 2022). In this study, the Cronbach Alpha coefficient was found to be 0.90 in
Dysphagia Assessment Scale in Multiple Sclerosis (DYMUS)
Time frame: Four months
Dysphagia Assessment Scale in Multiple Sclerosis (DYMUS) was developed by Bergamaschi et al. (2008) for the evaluation of oropharyngeal dysphagia in patients with Multiple Sclerosis (Bergamaschi et al., 2008). In the scale, the dysphagia score for solids is calculated by adding the 1st, 3rd, 4th, 5th, 7th, 8th and 10th items, and the dysphagia score for liquids is calculated by adding the 2nd, 6th and 9th items. Scale items are coded as "No = 0" and "Yes = 1". Scores between 0 and 10 can be obtained from the scale. A score of 1 or above indicates the presence of dysphagia, and a score of 3 or more indicates the presence of severe dysphagia. Turkish validity and reliability study was conducted by Tenekeci et al. and it has been reported that the total scale of Cronbach's Alpha coefficient has been 0.91 (Tenekeci et al., 2018). In this study, the Cronbach Alpha coefficient was in the pre-test 0.85; it was in the post-test 0.86. Although the scale was developed for patients with MS, app
The Mini Nutritional Assessment (MND) Test
Time frame: Four months
The Mini Nutritional Assessment (MND) Test was developed in 1994 in collaboration between the University of TOULOUSE, New Mexico Medical School and Nestle Research Center (Switzerland). MND is widely used in community clinical practice to examine the nutritional status of the elderly and dementia patients. The test consists of 18 items covering anthropometric measurements, dietary behaviours, and global and subjective factors. Malnutrition Indicator Score (MGP) is calculated by summing the preliminary evaluation score and the comprehensive evaluation score. Malnutrition Indicator Score (MGP) can be at least 0 and at most 30. The range of 24-30 points indicates no risk of malnutrition, the range of 17-23.5 points indicates the risk of malnutrition, and scores less than 17 indicate the presence of malnutrition. Mini Nutritional Assessment (MND) is a common screening tool (Guigoz, 2006). Cronbach's alpha coefficient was reported as 0.65 in elderly people with early-stage dementia (Holm \&
The Sarcopenia Screening Test (SARC-F)
Time frame: Four months
The Sarcopenia Screening Test (SARC-F) was developed as a possible rapid diagnostic test for (Malmstrom \& Morley, 2013) questions the individual's assistance needed for weight bearing, walking, getting up from a chair/bed, climbing stairs, and the experience of falling. Scores range from 0 to 10, with 0-2 points for each component. The 0-3 points range represents healthy, and 4 points and above represent sarcopenia and poor outcomes. Its suitability for the geriatric population in Turkey was checked by Kış and Karaca (2021) (Cronbach Alpha coefficient = 0.60) (Kış \& Karaca, 2021). In this study, the Cronbach Alpha coefficient was in the pre-test 0.79; it was in the post-test 0.76.
BMI
Time frame: Four months
In this study, BMI was used to evaluate the nutritional status of the patient with dementia. In a similar study (Salva et al., 2011) in the literature on the nutrition of dementia patients, weight was monitored by mail. Care was taken to ensure that the measurements were made by the instructions and by the same person.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No. The data may be shared with individual researchers upon request after the study has been completed and published; however, for data security reasons, sharing the data before publication is not being considered.
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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 Education in people with Dementia and Nutrition, run by Manisa Celal Bayar 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 7 inclusion and 1 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: finished, as of the sponsor's last update on 18 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Edinburgh Nutrition Assessment in Dementia ( EdFED ) Scale (time frame: Four months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.