Nutrition Disorders in Old AgeNCT04003493
LifE Style, Nutrition and Oral Health in Care Givers (LENTO)
A study testing Nutrition and oral health intervention in people with Nutrition Disorders in Old Age and Caries,Dental, run by University of Eastern Finland at 1 site in Finland.
Trial summary
The LENTO study sample includes the caregivers and their clients living in eastern Finland. The aims of this study are 1. to study the nutritional status, oral health, coping, functional capacity and quality of life 2. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutrition Disorders in Old Age, Caries,Dental, Dentures
- What is being tested?
- Nutrition and oral health intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFinland
- Study dates
- 15 May 2019to 31 Dec 2020
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- caregivers who have a caregiver´s contract valid on 1 January 2019
- care recipients living at home
Who cannot join
- in terminal care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LifE Style, Nutrition and Oral Health in Care Givers)
The LENTO study sample includes the caregivers and their clients living in eastern Finland. The aims of this study are
- to study the nutritional status, oral health, coping, functional capacity and quality of life
- to find out how individual nutrition and oral health counseling received for caregivers affect on the nutritional status and oral health of caregivers and their clients
- develop an operating model to maintain good nutrition and oral health.
Read the detailed description
In Finland, the aim is to reduce the institutional care of older people and caring them in their own homes. The goal of shifting the focus of services to open services is difficult to implement if the health of the caregivers is inadequate. In order to achieve this goal, it is important to influence the health and performance of caregivers. Information is needed to support this, among others, about how the nutrition and oral health of caregivers can be promoted and to what extent this affects the performance and quality of life of their clients. A randomly of 220 caregivers over 65 years old and their clients is selected for this study. The caregivers are randomized to either treatment or control groups. At the beginning of the study is estimated the nutritional status and oral health of the caregivers. Based on the results, the nutritionist and dental hygienist give individual advice to optimize the nutrition and oral health of the caregivers in the intervention group. After six months, the same measurements are made as at the beginning of the study. Monitoring measurements will be made one year after the start of the intervention. The results of this project provide information on the health, well-being, and ability to the function of the caregivers. Based on the results, is developed an operating model that is intended to be wide as use as possible. Improving the nutrition and oral health of caregivers has a significant impact on their own and their clients health and well-being as well as the long-term care costs presumably.
- Conditions
- Nutrition Disorders in Old Age, Caries,Dental, Dentures, Oral Mucositis, Tooth Diseases, Plaque, Dental
- Being tested
- Nutrition and oral health intervention
- Keywords
- Nutrition, Oral health, Care givers, Home care clients, Quality of life
- Medical subject headings
- Dental Caries, Stomatitis, Tooth Diseases, Dental Plaque, Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition and oral health interventionOther
The interventions included individualised nutrition and oral health care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group of nutrition | Experimental | On the basis of a blood test, Mini Nutritional Assessment, food diary and nutritional anamnesis, the nutritionist developed a plan for individualised nutritional care and discussed with the caregivers. If the caregivers seemed unable to increase the energy and/or protein of their diet, daily complementary dietary drinks were recommended to them. The participants were re-examined six months after the baseline interviews to evaluate the effectiveness of the interventions. Receives: Other: Nutrition and oral health intervention |
| Control group of nutrition | No intervention | The control group has the same examinations as the intervention group, they do not get dietary counseling. |
| Intervention group of oral health | Experimental | After the dental hygienist interview and oral health examination, the caregivers in need were targeted for oral health intervention. The intervention included individualised instructions on either dental hygiene, denture hygiene, cleaning of the oral mucosa or for dry mouth. The participants were re-examined six months after the baseline interviews to evaluate the effectiveness of the interventions. Receives: Other: Nutrition and oral health intervention |
| Control group of oral health | No intervention | The control group has the same examinations as the intervention group, they do not get oral health counseling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status
Change in MNA scores
Measured: Baseline and 6 months and (12 months follow-up visit)
Albumin
Change in plasma albumin concentration
Measured: Baseline and 6 months and (12 months follow-up visit)
Prealbumin
Change in plasma prealbumin concentration
Measured: Baseline and 6 months and (12 months follow-up visit)
Body mass index (kg/m2)
Change in BMI
Measured: Baseline and 6 months and (12 months follow-up visit)
Hand grip strength
Change in had grip strength of boot hands
Measured: Baseline and 6 months and (12 months follow-up visit)
Number and location of teeth
Change in number and location of teeth
Measured: Baseline and 6 months and (12 months follow-up visit)
Type and location of removable dental prosthesis
Change in type and location of removable dental prosthesis
Measured: Baseline and 6 months and (12 months follow-up visit)
Oral mucosa
Change in oral mucosa
Measured: Baseline and 6 months and (12 months follow-up visit)
Condition of teeth
Change in condition of teeth
Measured: Baseline and 6 months and (12 months follow-up visit)
Presence of plaque
Change in presence of plaque
Measured: Baseline and 6 months and (12 months follow-up visit)
Gingival bleeding and measurement of periodontal pockets
Change in gingival bleeding and measurement of periodontal pockets
Measured: Baseline and 6 months and (12 months follow-up visit)
Dental and denture hygiene
Change dental and denture hygiene
Measured: Baseline and 6 months and (12 months follow-up visit)
Subjective feeling of dry mouth and pain in mouth
Change in subjective feeling of dry mouth and pain in mouth
Measured: Baseline and 6 months and (12 months follow-up visit)
Secondary outcomes (7)
Activities of Daily Living
Change in Activities of Daily Living (ADL) scores
Measured: Baseline and 6 months and (12 months follow-up visit)
Instrumental Activities of Daily Living
Change in Instrumental Activities of Daily Living (IADL) scores
Measured: Baseline and 6 months and (12 months follow-up visit)
Quality of Life (WHOQOL) -bref scores
Change in quality of Life (WHOQOL) -bref scores
Measured: Baseline and 6 months and (12 months follow-up visit)
Depression
Change in Geriatric Depression Scale (GDS)-15 scores
Measured: Baseline and 6 months and (12 months follow-up visit)
Cognition
Change in Mini Mental State Examination (MMSE) scores
Measured: Baseline and 6 months and (12 months follow-up visit)
Sense of coherence
Change in sense of coherence (SOC) scores
Measured: Baseline and 6 months and (12 months follow-up visit)
Morbidity
Functional Comorbidity Index (FCI) scores
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start15 May 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Nutrition Disorders in Old AgeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Collaborators
- Kuopio University Hospital
- Responsible party
- Sponsor
- Investigators
- Ursula o Schwab, PhD, Study director, Study Principal Inverstigator, professorLiisa o Suominen, PhD, Principal investigator, Study Principal Inverstigator, professorTarja o Välimäki, PhD, Principal investigator, Study Principal Inverstigator, adjuct professorIrma o Nykänen, PhD, Principal investigator, Study Principal Investigator, adjuct professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003493
- Sponsor's protocol ID
- LENTO
- Status last verified
- Nov 2021
- First submitted
- 25 Jun 2019
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Razzaq S, Valimaki T, Nykanen I, Koponen S, Savela RM, Schwab U, Suominen AL. The Effect of an Individualized Oral Health Intervention on Oral Health-Related Behaviours Among Family Caregivers and Care Recipients. Gerodontology. 2026 Jul 9. doi: 10.1111/ger.70104. Online ahead of print.
PubMed 42423625Annina S, Irma N, Tarja V, Sohvi K, Roosa-Maria S, Ursula S, Suominen AL. The Effect of an Individually Tailored Oral Health Intervention on Dental Plaque and Caries Among Family Caregivers and Their Care Recipients. Gerodontology. 2025 Dec;42(4):495-506. doi: 10.1111/ger.12814. Epub 2025 Mar 25.
PubMed 40129259Koponen S, Nykanen I, Savela RM, Valimaki T, Suominen AL, Schwab U. Underweight, overweight, and weight change in older family caregivers and their care recipients: longitudinal evidence from a randomized controlled trial. Front Aging. 2024 Aug 15;5:1376825. doi: 10.3389/fragi.2024.1376825. eCollection 2024.
PubMed 39211745Koponen S, Nykanen I, Savela RM, Valimaki T, Suominen AL, Schwab U. Family caregivers' better nutritional status is associated with care recipients' better nutritional status. Clin Nutr ESPEN. 2024 Aug;62:199-205. doi: 10.1016/j.clnesp.2024.05.016. Epub 2024 May 28.
PubMed 38901942Razzaq S, Nykanen I, Valimaki T, Koponen S, Savela RM, Schwab U, Suominen AL. Use of oral health care services by family caregivers and care recipients: the LENTO intervention. Acta Odontol Scand. 2024 May 22;83:317-326. doi: 10.2340/aos.v83.40687.
PubMed 38775632Koponen S, Nykanen I, Savela RM, Valimaki T, Suominen AL, Schwab U. Depressive symptoms, low-grade inflammation, and poor oral health prevents the success of nutritional guidance in older caregivers. Clin Nutr ESPEN. 2023 Oct;57:39-47. doi: 10.1016/j.clnesp.2023.06.018. Epub 2023 Jun 22.
PubMed 37739684Koponen S, Nykanen I, Savela RM, Valimaki T, Suominen AL, Schwab U. Individually tailored nutritional guidance improved dietary intake of older family caregivers: a randomized controlled trial. Eur J Nutr. 2022 Oct;61(7):3585-3596. doi: 10.1007/s00394-022-02908-w. Epub 2022 May 27.
PubMed 35622137Nykanen I, Valimaki T, Suominen L, Schwab U. Optimizing nutrition and oral health for caregivers-intervention protocol. Trials. 2021 Sep 15;22(1):625. doi: 10.1186/s13063-021-05589-8.
PubMed 34526071
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LifE Style, Nutrition and Oral Health in Care Givers)
- ClinicalTrials.gov ID
- NCT04003493
- Acronym / sponsor ID
- LENTO
- Conditions
- Nutrition Disorders in Old Age, Caries,Dental, Dentures, Oral Mucositis, Tooth Diseases, Plaque, Dental
- Keywords
- Nutrition, Oral health, Care givers, Home care clients, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Collaborators
- Kuopio University Hospital
- Study start
- 15 May 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 1 Jul 2019 (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 LENTO study sample includes the caregivers and their clients living in eastern Finland. The aims of this study are
- to study the nutritional status, oral health, coping, functional capacity and quality of life
- to find out how individual nutrition and oral health counseling received for caregivers affect on the nutritional status and oral health of caregivers and their clients
- develop an operating model to maintain good nutrition and oral health.
Detailed description
In Finland, the aim is to reduce the institutional care of older people and caring them in their own homes. The goal of shifting the focus of services to open services is difficult to implement if the health of the caregivers is inadequate. In order to achieve this goal, it is important to influence the health and performance of caregivers. Information is needed to support this, among others, about how the nutrition and oral health of caregivers can be promoted and to what extent this affects the performance and quality of life of their clients. A randomly of 220 caregivers over 65 years old and their clients is selected for this study. The caregivers are randomized to either treatment or control groups. At the beginning of the study is estimated the nutritional status and oral health of the caregivers. Based on the results, the nutritionist and dental hygienist give individual advice to optimize the nutrition and oral health of the caregivers in the intervention group. After six months, the same measurements are made as at the beginning of the study. Monitoring measurements will be made one year after the start of the intervention. The results of this project provide information on the health, well-being, and ability to the function of the caregivers. Based on the results, is developed an operating model that is intended to be wide as use as possible. Improving the nutrition and oral health of caregivers has a significant impact on their own and their clients health and well-being as well as the long-term care costs presumably.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention group of nutrition | Experimental | Other: Nutrition and oral health interventionOn the basis of a blood test, Mini Nutritional Assessment, food diary and nutritional anamnesis, the nutritionist developed a plan for individualised nutritional care and discussed with the caregivers. If the caregivers seemed unable to increase the energy and/or protein of their diet, daily complementary dietary drinks were recommended to them. The participants were re-examined six months after the baseline interviews to evaluate the effectiveness of the interventions. |
| Control group of nutrition | No intervention | –The control group has the same examinations as the intervention group, they do not get dietary counseling. |
| Intervention group of oral health | Experimental | Other: Nutrition and oral health interventionAfter the dental hygienist interview and oral health examination, the caregivers in need were targeted for oral health intervention. The intervention included individualised instructions on either dental hygiene, denture hygiene, cleaning of the oral mucosa or for dry mouth. The participants were re-examined six months after the baseline interviews to evaluate the effectiveness of the interventions. |
| Control group of oral health | No intervention | –The control group has the same examinations as the intervention group, they do not get oral health counseling. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- caregivers who have a caregiver´s contract valid on 1 January 2019
- care recipients living at home
Key exclusion criteria (1 listed)
- in terminal care
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 |
|---|---|---|
| Nutrition and oral health interventionThe interventions included individualised nutrition and oral health care. | Other | Intervention group of nutrition, Intervention group of oral health |
Primary outcome
Nutritional status
Time frame: Baseline and 6 months and (12 months follow-up visit)
Change in MNA scores
Albumin
Time frame: Baseline and 6 months and (12 months follow-up visit)
Change in plasma albumin concentration
Prealbumin
Time frame: Baseline and 6 months and (12 months follow-up visit)
Change in plasma prealbumin concentration
Body mass index (kg/m2)
Time frame: Baseline and 6 months and (12 months follow-up visit)
Change in BMI
Hand grip strength
Time frame: Baseline and 6 months and (12 months follow-up visit)
Change in had grip strength of boot hands
Number and location of teeth
Time frame: Baseline and 6 months and (12 months follow-up visit)
Change in number and location of teeth
Type and location of removable dental prosthesis
Time frame: Baseline and 6 months and (12 months follow-up visit)
Change in type and location of removable dental prosthesis
Oral mucosa
Time frame: Baseline and 6 months and (12 months follow-up visit)
Change in oral mucosa
Condition of teeth
Time frame: Baseline and 6 months and (12 months follow-up visit)
Change in condition of teeth
Presence of plaque
Time frame: Baseline and 6 months and (12 months follow-up visit)
Change in presence of plaque
Gingival bleeding and measurement of periodontal pockets
Time frame: Baseline and 6 months and (12 months follow-up visit)
Change in gingival bleeding and measurement of periodontal pockets
Dental and denture hygiene
Time frame: Baseline and 6 months and (12 months follow-up visit)
Change dental and denture hygiene
Subjective feeling of dry mouth and pain in mouth
Time frame: Baseline and 6 months and (12 months follow-up visit)
Change in subjective feeling of dry mouth and pain in mouth
7 secondary outcomes
Activities of Daily Living
Time frame: Baseline and 6 months and (12 months follow-up visit)
Instrumental Activities of Daily Living
Time frame: Baseline and 6 months and (12 months follow-up visit)
Quality of Life (WHOQOL) -bref scores
Time frame: Baseline and 6 months and (12 months follow-up visit)
Depression
Time frame: Baseline and 6 months and (12 months follow-up visit)
Cognition
Time frame: Baseline and 6 months and (12 months follow-up visit)
Sense of coherence
Time frame: Baseline and 6 months and (12 months follow-up visit)
Morbidity
Time frame: Baseline
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 11 Nov 2021.
- Derived from this study: PubMed 42423625Razzaq S, Valimaki T, Nykanen I, Koponen S, Savela RM, Schwab U, Suominen AL. The Effect of an Individualized Oral Health Intervention on Oral Health-Related Behaviours Among Family Caregivers and Care Recipients. Gerodontology. 2026 Jul 9. doi: 10.1111/ger.70104. Online ahead of print.
- Derived from this study: PubMed 40129259Annina S, Irma N, Tarja V, Sohvi K, Roosa-Maria S, Ursula S, Suominen AL. The Effect of an Individually Tailored Oral Health Intervention on Dental Plaque and Caries Among Family Caregivers and Their Care Recipients. Gerodontology. 2025 Dec;42(4):495-506. doi: 10.1111/ger.12814. Epub 2025 Mar 25.
- Derived from this study: PubMed 39211745Koponen S, Nykanen I, Savela RM, Valimaki T, Suominen AL, Schwab U. Underweight, overweight, and weight change in older family caregivers and their care recipients: longitudinal evidence from a randomized controlled trial. Front Aging. 2024 Aug 15;5:1376825. doi: 10.3389/fragi.2024.1376825. eCollection 2024.
- Derived from this study: PubMed 38901942Koponen S, Nykanen I, Savela RM, Valimaki T, Suominen AL, Schwab U. Family caregivers' better nutritional status is associated with care recipients' better nutritional status. Clin Nutr ESPEN. 2024 Aug;62:199-205. doi: 10.1016/j.clnesp.2024.05.016. Epub 2024 May 28.
- Derived from this study: PubMed 38775632Razzaq S, Nykanen I, Valimaki T, Koponen S, Savela RM, Schwab U, Suominen AL. Use of oral health care services by family caregivers and care recipients: the LENTO intervention. Acta Odontol Scand. 2024 May 22;83:317-326. doi: 10.2340/aos.v83.40687.
- Derived from this study: PubMed 37739684Koponen S, Nykanen I, Savela RM, Valimaki T, Suominen AL, Schwab U. Depressive symptoms, low-grade inflammation, and poor oral health prevents the success of nutritional guidance in older caregivers. Clin Nutr ESPEN. 2023 Oct;57:39-47. doi: 10.1016/j.clnesp.2023.06.018. Epub 2023 Jun 22.
- Derived from this study: PubMed 35622137Koponen S, Nykanen I, Savela RM, Valimaki T, Suominen AL, Schwab U. Individually tailored nutritional guidance improved dietary intake of older family caregivers: a randomized controlled trial. Eur J Nutr. 2022 Oct;61(7):3585-3596. doi: 10.1007/s00394-022-02908-w. Epub 2022 May 27.
- Derived from this study: PubMed 34526071Nykanen I, Valimaki T, Suominen L, Schwab U. Optimizing nutrition and oral health for caregivers-intervention protocol. Trials. 2021 Sep 15;22(1):625. doi: 10.1186/s13063-021-05589-8.
- Individual participant dataSharing planned: No
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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.
Ursula o Schwab, PhD study director
Study Principal Inverstigator, professor
Liisa o Suominen, PhD principal investigator
Study Principal Inverstigator, professor
Tarja o Välimäki, PhD principal investigator
Study Principal Inverstigator, adjuct professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition and oral health intervention in people with Nutrition Disorders in Old Age and Caries,Dental, run by University of Eastern Finland at 1 site in Finland.
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 2 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 11 Nov 2021. 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 Finland. 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?
Nutritional status (time frame: Baseline and 6 months and (12 months follow-up visit)). The study lists 13 primary outcomes in all. 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 NCT04003493, which also lists 8 linked publications.
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 11 Nov 2021.