NCT04003493

Brief Summary

The LENTO study sample includes the caregivers and their clients living in eastern Finland. The aims of this study are

  1. 1.to study the nutritional status, oral health, coping, functional capacity and quality of life
  2. 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. 3.develop an operating model to maintain good nutrition and oral health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 15, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 25, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

November 11, 2021

Status Verified

November 1, 2021

Enrollment Period

1.6 years

First QC Date

June 25, 2019

Last Update Submit

November 10, 2021

Conditions

Nutrition Disorders in Old AgeCaries,DentalDenturesOral MucositisTooth DiseasesPlaque, DentalGingival Diseases

Keywords

NutritionOral healthCare giversHome care clientsQuality of life

Outcome Measures

Primary Outcomes (13)

  • Nutritional status

    Change in MNA scores

    Baseline and 6 months and (12 months follow-up visit)

  • Albumin

    Change in plasma albumin concentration

    Baseline and 6 months and (12 months follow-up visit)

  • Prealbumin

    Change in plasma prealbumin concentration

    Baseline and 6 months and (12 months follow-up visit)

  • Body mass index (kg/m2)

    Change in BMI

    Baseline and 6 months and (12 months follow-up visit)

  • Hand grip strength

    Change in had grip strength of boot hands

    Baseline and 6 months and (12 months follow-up visit)

  • Number and location of teeth

    Change in number and location of teeth

    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

    Baseline and 6 months and (12 months follow-up visit)

  • Oral mucosa

    Change in oral mucosa

    Baseline and 6 months and (12 months follow-up visit)

  • Condition of teeth

    Change in condition of teeth

    Baseline and 6 months and (12 months follow-up visit)

  • Presence of plaque

    Change in presence of plaque

    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

    Baseline and 6 months and (12 months follow-up visit)

  • Dental and denture hygiene

    Change dental and denture hygiene

    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

    Baseline and 6 months and (12 months follow-up visit)

Secondary Outcomes (7)

  • Activities of Daily Living

    Baseline and 6 months and (12 months follow-up visit)

  • Instrumental Activities of Daily Living

    Baseline and 6 months and (12 months follow-up visit)

  • Quality of Life (WHOQOL) -bref scores

    Baseline and 6 months and (12 months follow-up visit)

  • Depression

    Baseline and 6 months and (12 months follow-up visit)

  • Cognition

    Baseline and 6 months and (12 months follow-up visit)

  • +2 more secondary outcomes

Study Arms (4)

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.

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.

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.

Interventions

Nutrition and oral health interventionOTHER

The interventions included individualised nutrition and oral health care.

Intervention group of nutritionIntervention group of oral health

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • in terminal care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Eastern Finland

Kuopio, FI-70210, Finland

Location

Related Publications (7)

  • Annina 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.

    PMID: 40129259DERIVED

  • 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.

    PMID: 39211745DERIVED

  • 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.

    PMID: 38901942DERIVED

  • 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.

    PMID: 38775632DERIVED

  • 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.

    PMID: 37739684DERIVED

  • 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.

    PMID: 35622137DERIVED

  • 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.

    PMID: 34526071DERIVED

MeSH Terms

Conditions

Dental CariesStomatitisTooth DiseasesDental PlaqueGingival Diseases

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Tooth DemineralizationStomatognathic DiseasesMouth DiseasesDental DepositsPeriodontal Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Ursula o Schwab, PhD

    Study Principal Inverstigator, professor

    STUDY DIRECTOR

  • Liisa o Suominen, PhD

    Study Principal Inverstigator, professor

    PRINCIPAL INVESTIGATOR

  • Tarja o Välimäki, PhD

    Study Principal Inverstigator, adjuct professor

    PRINCIPAL INVESTIGATOR

  • Irma o Nykänen, PhD

    Study Principal Investigator, adjuct professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2019

First Posted

July 1, 2019

Study Start

May 15, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

November 11, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)