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LifE Style, Nutrition and Oral Health in Care Givers (LENTO)

NCT ID: NCT04003493

Last Updated: 2021-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-15

Study Completion Date

2020-12-31

Brief Summary

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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. 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
3. develop an operating model to maintain good nutrition and oral health.

Detailed Description

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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

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Nutrition Disorders in Old Age Caries,Dental Dentures Oral Mucositis Tooth Diseases Plaque, Dental Gingival Diseases

Keywords

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Nutrition Oral health Care givers Home care clients Quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intervention group of nutrition

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.

Group Type EXPERIMENTAL

Nutrition and oral health intervention

Intervention Type OTHER

The interventions included individualised nutrition and oral health care.

Control group of nutrition

The control group has the same examinations as the intervention group, they do not get dietary counseling.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group of oral health

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.

Group Type EXPERIMENTAL

Nutrition and oral health intervention

Intervention Type OTHER

The interventions included individualised nutrition and oral health care.

Control group of oral health

The control group has the same examinations as the intervention group, they do not get oral health counseling.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nutrition and oral health intervention

The interventions included individualised nutrition and oral health care.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* caregivers who have a caregiver´s contract valid on 1 January 2019
* care recipients living at home

Exclusion Criteria

* in terminal care
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role collaborator

University of Eastern Finland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ursula o Schwab, PhD

Role: STUDY_DIRECTOR

Study Principal Inverstigator, professor

Liisa o Suominen, PhD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Inverstigator, professor

Tarja o Välimäki, PhD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Inverstigator, adjuct professor

Irma o Nykänen, PhD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator, adjuct professor

Locations

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University of Eastern Finland

Kuopio, , Finland

Site Status

Countries

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Finland

References

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Annina S, Irma N, Tarja V, Sohvi K, Roosa-Maria S, Ursula S, Liisa SA. The Effect of an Individually Tailored Oral Health Intervention on Dental Plaque and Caries Among Family Caregivers and Their Care Recipients. Gerodontology. 2025 Mar 25. doi: 10.1111/ger.12814. Online ahead of print.

Reference Type DERIVED
PMID: 40129259 (View on PubMed)

Koponen 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.

Reference Type DERIVED
PMID: 39211745 (View on PubMed)

Koponen 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.

Reference Type DERIVED
PMID: 38901942 (View on PubMed)

Razzaq 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.

Reference Type DERIVED
PMID: 38775632 (View on PubMed)

Koponen 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.

Reference Type DERIVED
PMID: 37739684 (View on PubMed)

Koponen 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.

Reference Type DERIVED
PMID: 35622137 (View on PubMed)

Nykanen 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.

Reference Type DERIVED
PMID: 34526071 (View on PubMed)

Other Identifiers

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LENTO

Identifier Type: -

Identifier Source: org_study_id