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

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

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.

Study Overview

• Status: Completed
• Conditions: Gingival Diseases; Tooth Diseases; Plaque, Dental; Oral Mucositis; Caries,Dental; Dentures; Nutrition Disorders in Old Age
• Intervention / Treatment: Other: Nutrition and oral health intervention

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 Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Kuopio, Finland, FI-70210
    • University of Eastern Finland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• in terminal care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Nutrition and oral health intervention; The interventions included individualised nutrition and oral health care.
No Intervention: Control group of nutrition; The control group has the same examinations as the intervention group, they do not get dietary counseling.
Experimental: 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.	Other: Nutrition and oral health intervention; The interventions included individualised nutrition and oral health care.
No Intervention: Control group of oral health; The control group has the same examinations as the intervention group, they do not get oral health counseling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activities of Daily Living	Change in Activities of Daily Living (ADL) scores	Baseline and 6 months and (12 months follow-up visit)
Instrumental Activities of Daily Living	Change in Instrumental Activities of Daily Living (IADL) scores	Baseline and 6 months and (12 months follow-up visit)
Quality of Life (WHOQOL) -bref scores	Change in quality of Life (WHOQOL) -bref scores	Baseline and 6 months and (12 months follow-up visit)
Depression	Change in Geriatric Depression Scale (GDS)-15 scores	Baseline and 6 months and (12 months follow-up visit)
Cognition	Change in Mini Mental State Examination (MMSE) scores	Baseline and 6 months and (12 months follow-up visit)
Sense of coherence	Change in sense of coherence (SOC) scores	Baseline and 6 months and (12 months follow-up visit)
Morbidity	Functional Comorbidity Index (FCI) scores	Baseline

Collaborators and Investigators

• Sponsor: University of Eastern Finland
• Collaborators: Kuopio University Hospital
• Investigators: Study Director: Ursula o Schwab, PhD, Study Principal Inverstigator, professor; Principal Investigator: 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

Publications and helpful links

General Publications

• Koponen S, Nykänen I, Savela RM, Välimäki 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.
• Nykänen I, Välimäki 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: June 28, 2019
• First Posted (Actual): July 1, 2019

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 10, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Quality of life; Nutrition; Oral health; Care givers; Home care clients
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Demineralization; Dental Deposits; Dental Caries; Mucositis; Nutrition Disorders; Dental Plaque; Stomatitis; Tooth Diseases; Gingival Diseases
• Other Study ID Numbers: LENTO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No