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

November 10, 2021 updated by: University of Eastern Finland

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Nutritional status
Time Frame: Baseline and 6 months and (12 months follow-up visit)
Change in MNA scores
Baseline and 6 months and (12 months follow-up visit)
Albumin
Time Frame: Baseline and 6 months and (12 months follow-up visit)
Change in plasma albumin concentration
Baseline and 6 months and (12 months follow-up visit)
Prealbumin
Time Frame: Baseline and 6 months and (12 months follow-up visit)
Change in plasma prealbumin concentration
Baseline and 6 months and (12 months follow-up visit)
Body mass index (kg/m2)
Time Frame: Baseline and 6 months and (12 months follow-up visit)
Change in BMI
Baseline and 6 months and (12 months follow-up visit)
Hand grip strength
Time Frame: Baseline and 6 months and (12 months follow-up visit)
Change in had grip strength of boot hands
Baseline and 6 months and (12 months follow-up visit)
Number and location of teeth
Time Frame: Baseline and 6 months and (12 months follow-up visit)
Change in number and location of teeth
Baseline and 6 months and (12 months follow-up visit)
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
Baseline and 6 months and (12 months follow-up visit)
Oral mucosa
Time Frame: Baseline and 6 months and (12 months follow-up visit)
Change in oral mucosa
Baseline and 6 months and (12 months follow-up visit)
Condition of teeth
Time Frame: Baseline and 6 months and (12 months follow-up visit)
Change in condition of teeth
Baseline and 6 months and (12 months follow-up visit)
Presence of plaque
Time Frame: Baseline and 6 months and (12 months follow-up visit)
Change in presence of plaque
Baseline and 6 months and (12 months follow-up visit)
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
Baseline and 6 months and (12 months follow-up visit)
Dental and denture hygiene
Time Frame: Baseline and 6 months and (12 months follow-up visit)
Change dental and denture hygiene
Baseline and 6 months and (12 months follow-up visit)
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
Baseline and 6 months and (12 months follow-up visit)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Activities of Daily Living
Time Frame: Baseline and 6 months and (12 months follow-up visit)
Change in Activities of Daily Living (ADL) scores
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)
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
Time Frame: Baseline and 6 months and (12 months follow-up visit)
Change in quality of Life (WHOQOL) -bref scores
Baseline and 6 months and (12 months follow-up visit)
Depression
Time Frame: Baseline and 6 months and (12 months follow-up visit)
Change in Geriatric Depression Scale (GDS)-15 scores
Baseline and 6 months and (12 months follow-up visit)
Cognition
Time Frame: Baseline and 6 months and (12 months follow-up visit)
Change in Mini Mental State Examination (MMSE) scores
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)
Change in sense of coherence (SOC) scores
Baseline and 6 months and (12 months follow-up visit)
Morbidity
Time Frame: Baseline
Functional Comorbidity Index (FCI) scores
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Eastern Finland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kuopio University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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