Impact on Energy Intake by Implementing Recommended Food Texture Through Dietary Guidance
NCT ID: NCT04655547
Last Updated: 2021-12-17
Study Results
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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COMPLETED
NA
13 participants
INTERVENTIONAL
2021-03-08
2021-12-09
Brief Summary
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Energy- and protein intake, Weightloss, Bodymass composition, Fluid balance and Activities of Daily Living (ADL), will be measured by Bioimpedance spectroscopy, interviews and a questionnaire.
Detailed Description
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ADL will in this project have its focus on the eating situation.
The projects research questions are:
* Will dietary guidance with texture implementation increase energy intake in patients being examined on an outpatient basis for dysphagia, based on the Fiberoptic Endoscopic Evaluation of Swallowing (FEES) recommendation?
* Can a dietetic guidance with texture implementation increase quality of life and ADL in patients with dysphagia?
Recruitment and data collection will take place at Hammel Neurocenter, DK.
Each patient will be included for eight weeks, after their first FEES examination. The participants will be randomized to control or intervention, and strata into three groups based on Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) 1, 2-3 and 4.
Within the eight weeks, participants have to show up three times to measurements, interviews and questionnaire, in addition to this, the intervention groups will have three follow-up phone meetings.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
The study will include 34 participants - 17 in each group.
SUPPORTIVE_CARE
NONE
Study Groups
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Control
The participants will follow the usual offered course on the outpatient clinic of Hammel Neurocenter. They wil anticipate in data collection three times in line with the intervention group.
No interventions assigned to this group
Intervention
The participants will receive dietary guidance from an dietician, with focus on energy intake and food texture. This guidance will include two sessions on site and three phone meetings. The last on site meeting, will be concluding.
Dietary guidance
Dietary guidance with focus on texture and energy intake, preformed by certified dietitians.
Interventions
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Dietary guidance
Dietary guidance with focus on texture and energy intake, preformed by certified dietitians.
Eligibility Criteria
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Inclusion Criteria
* Newly refered patients to FEES examination
* Score 1-4 on FEDSS-scale
* Consumes 50% energy or more orally
* Consumes less energy than calculated energy need (Harris-Benedict)
* Individuals of full legal capacity
* Individuals above 18 of years
* That the patient is capable of executing examinations
Exclusion Criteria
* Ineligible individuals
* Individual in need of translator
* Individuals participating in another trial
18 Years
99 Years
ALL
No
Sponsors
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University of Copenhagen
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Jesper Fabricius, Ph.d.
Role: PRINCIPAL_INVESTIGATOR
Hammel Neurorehabilitation Centre and University Research Clinic
Locations
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Hammel Neurorehabilitation Centre and University Research Clinic
Hammel, Central Jutland, Denmark
Countries
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Other Identifiers
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MS19953
Identifier Type: -
Identifier Source: org_study_id