Clinical trial NCT04655547: Impact on Energy Intake by Implementing Recommended Food Texture Through Dietary Guidance
Official title: Impact on Energy Intake by Implementing Recommended Food Texture Through Dietary Guidance at the Department of Swallowing and Eating Disorders; a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Energy Intake
Activities of Daily Living
Quality of Life
Protein Intake
Fluid Balance
Lean Body Mass
Fat Mass
Weight
Keywords: Dysphagia
Dietary Guidance
Energy- and Protein intake
Food Texture
Activities of Daily Living and Quality of Life
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2020-12-07
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to control or intervention group, stratified on their FEDSS-score.

The study will include 34 participants - 17 in each group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: An intervention study on the effect of dietary guidance with focus on implementing recommended food texture, at the department of Eating and Swallowing difficulties, Region Midtjylland, Denmark.

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: It is know that people with eating- and swallowing difficulties(known as dysphagia), is prone to weightloss due to insufficient energy- and protein intake, and a reduction in ADL.

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.

Eligibility criteria: Inclusion Criteria:

* Signed consent form
* 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:

* Individuals with known eating disorders
* Ineligible individuals
* Individual in need of translator
* Individuals participating in another trial

Primary outcomes:
measure: Changes in energy intake, from baseline.
timeFrame: Eight weeks
Secondary outcomes:
measure: Changes in Dysphagia Handicap Index (DHI) total and section (E and F) score.
timeFrame: Eight weeks
measure: In how many questions in the DHI, does the intervention group change the score in relation to the control group, and with how much.
timeFrame: Eight weeks
measure: Body Weight.
timeFrame: Eight weeks
measure: Lean Body Mass.
timeFrame: Eight weeks
measure: Fat Mass.
timeFrame: Eight weeks
measure: Fluid Balance.
timeFrame: Eight weeks
measure: Changes in protein intake.
timeFrame: Eight weeks
measure: Compliance of recommended changes.
timeFrame: Eight weeks
Other outcomes:
Locations:
city: Hammel
country: Denmark
facility: Hammel Neurorehabilitation Centre and University Research Clinic
state: Midtjylland
Study officials:
affiliation: Hammel Neurorehabilitation Centre and University Research Clinic
name: Jesper Fabricius, Ph.d.
role: PRINCIPAL_INVESTIGATOR
References: