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

Primary Purpose

Nutrition Disorders in Old Age, Caries,Dental, Dentures

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Nutrition and oral health intervention
Sponsored by
University of Eastern Finland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nutrition Disorders in Old Age focused on measuring Nutrition, Oral health, Care givers, Home care clients, Quality of life

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • in terminal care

Sites / Locations

  • University of Eastern Finland

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Intervention group of nutrition

Control group of nutrition

Intervention group of oral health

Control group of oral health

Arm Description

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.

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

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.

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

Outcomes

Primary Outcome Measures

Nutritional status
Change in MNA scores
Albumin
Change in plasma albumin concentration
Prealbumin
Change in plasma prealbumin concentration
Body mass index (kg/m2)
Change in BMI
Hand grip strength
Change in had grip strength of boot hands
Number and location of teeth
Change in number and location of teeth
Type and location of removable dental prosthesis
Change in type and location of removable dental prosthesis
Oral mucosa
Change in oral mucosa
Condition of teeth
Change in condition of teeth
Presence of plaque
Change in presence of plaque
Gingival bleeding and measurement of periodontal pockets
Change in gingival bleeding and measurement of periodontal pockets
Dental and denture hygiene
Change dental and denture hygiene
Subjective feeling of dry mouth and pain in mouth
Change in subjective feeling of dry mouth and pain in mouth

Secondary Outcome Measures

Activities of Daily Living
Change in Activities of Daily Living (ADL) scores
Instrumental Activities of Daily Living
Change in Instrumental Activities of Daily Living (IADL) scores
Quality of Life (WHOQOL) -bref scores
Change in quality of Life (WHOQOL) -bref scores
Depression
Change in Geriatric Depression Scale (GDS)-15 scores
Cognition
Change in Mini Mental State Examination (MMSE) scores
Sense of coherence
Change in sense of coherence (SOC) scores
Morbidity
Functional Comorbidity Index (FCI) scores

Full Information

First Posted
June 25, 2019
Last Updated
November 10, 2021
Sponsor
University of Eastern Finland
Collaborators
Kuopio University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04003493
Brief Title
LifE Style, Nutrition and Oral Health in Care Givers (LENTO)
Official Title
LifE Style, Nutrition and Oral Health in Care Givers)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Eastern Finland
Collaborators
Kuopio University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition Disorders in Old Age, Caries,Dental, Dentures, Oral Mucositis, Tooth Diseases, Plaque, Dental, Gingival Diseases
Keywords
Nutrition, Oral health, Care givers, Home care clients, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group of nutrition
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group of nutrition
Arm Type
No Intervention
Arm Description
The control group has the same examinations as the intervention group, they do not get dietary counseling.
Arm Title
Intervention group of oral health
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group of oral health
Arm Type
No Intervention
Arm Description
The control group has the same examinations as the intervention group, they do not get oral health counseling.
Intervention Type
Other
Intervention Name(s)
Nutrition and oral health intervention
Intervention Description
The interventions included individualised nutrition and oral health care.
Primary Outcome Measure Information:
Title
Nutritional status
Description
Change in MNA scores
Time Frame
Baseline and 6 months and (12 months follow-up visit)
Title
Albumin
Description
Change in plasma albumin concentration
Time Frame
Baseline and 6 months and (12 months follow-up visit)
Title
Prealbumin
Description
Change in plasma prealbumin concentration
Time Frame
Baseline and 6 months and (12 months follow-up visit)
Title
Body mass index (kg/m2)
Description
Change in BMI
Time Frame
Baseline and 6 months and (12 months follow-up visit)
Title
Hand grip strength
Description
Change in had grip strength of boot hands
Time Frame
Baseline and 6 months and (12 months follow-up visit)
Title
Number and location of teeth
Description
Change in number and location of teeth
Time Frame
Baseline and 6 months and (12 months follow-up visit)
Title
Type and location of removable dental prosthesis
Description
Change in type and location of removable dental prosthesis
Time Frame
Baseline and 6 months and (12 months follow-up visit)
Title
Oral mucosa
Description
Change in oral mucosa
Time Frame
Baseline and 6 months and (12 months follow-up visit)
Title
Condition of teeth
Description
Change in condition of teeth
Time Frame
Baseline and 6 months and (12 months follow-up visit)
Title
Presence of plaque
Description
Change in presence of plaque
Time Frame
Baseline and 6 months and (12 months follow-up visit)
Title
Gingival bleeding and measurement of periodontal pockets
Description
Change in gingival bleeding and measurement of periodontal pockets
Time Frame
Baseline and 6 months and (12 months follow-up visit)
Title
Dental and denture hygiene
Description
Change dental and denture hygiene
Time Frame
Baseline and 6 months and (12 months follow-up visit)
Title
Subjective feeling of dry mouth and pain in mouth
Description
Change in subjective feeling of dry mouth and pain in mouth
Time Frame
Baseline and 6 months and (12 months follow-up visit)
Secondary Outcome Measure Information:
Title
Activities of Daily Living
Description
Change in Activities of Daily Living (ADL) scores
Time Frame
Baseline and 6 months and (12 months follow-up visit)
Title
Instrumental Activities of Daily Living
Description
Change in Instrumental Activities of Daily Living (IADL) scores
Time Frame
Baseline and 6 months and (12 months follow-up visit)
Title
Quality of Life (WHOQOL) -bref scores
Description
Change in quality of Life (WHOQOL) -bref scores
Time Frame
Baseline and 6 months and (12 months follow-up visit)
Title
Depression
Description
Change in Geriatric Depression Scale (GDS)-15 scores
Time Frame
Baseline and 6 months and (12 months follow-up visit)
Title
Cognition
Description
Change in Mini Mental State Examination (MMSE) scores
Time Frame
Baseline and 6 months and (12 months follow-up visit)
Title
Sense of coherence
Description
Change in sense of coherence (SOC) scores
Time Frame
Baseline and 6 months and (12 months follow-up visit)
Title
Morbidity
Description
Functional Comorbidity Index (FCI) scores
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: caregivers who have a caregiver´s contract valid on 1 January 2019 care recipients living at home Exclusion Criteria: in terminal care
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ursula o Schwab, PhD
Organizational Affiliation
Study Principal Inverstigator, professor
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Liisa o Suominen, PhD
Organizational Affiliation
Study Principal Inverstigator, professor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tarja o Välimäki, PhD
Organizational Affiliation
Study Principal Inverstigator, adjuct professor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Irma o Nykänen, PhD
Organizational Affiliation
Study Principal Investigator, adjuct professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Eastern Finland
City
Kuopio
ZIP/Postal Code
FI-70210
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35622137
Citation
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.
Results Reference
derived
PubMed Identifier
34526071
Citation
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.
Results Reference
derived

Learn more about this trial

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

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