Impact on Energy Intake by Implementing Recommended Food Texture Through Dietary Guidance

Impact on Energy Intake by Implementing Recommended Food Texture Through Dietary Guidance at the Department of Swallowing and Eating Disorders; a Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Weight; Activities of Daily Living; Energy Intake; Protein Intake; Fluid Balance; Lean Body Mass; Fat Mass
• Intervention / Treatment: Other: Dietary guidance

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Midtjylland
    • Hammel, Midtjylland, Denmark, 8450
      • Hammel neurorehabilitation centre and university research clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Other: Dietary guidance; Dietary guidance with focus on texture and energy intake, preformed by certified dietitians.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in energy intake, from baseline.	Change in energy intake, measured from baseline. Measured in kilojoule by a standardized interview with examples of pictures to determine serving size.	Eight weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Dysphagia Handicap Index (DHI) total and section (E and F) score.	DHI is a questionnaire with 25 questions, divided into three sections. possible scores are minimum 25 and maximum 125. The higher the score, the worse dysphagia status. Measured in points, changes from baseline.	Eight weeks
In how many questions in the DHI, does the intervention group change the score in relation to the control group, and with how much.	Measured in points, changes from baseline.	Eight weeks
Body Weight.	Measured in kilograms, by bioimpedance spectroscopy, changes from baseline.	Eight weeks
Lean Body Mass.	Measured in kilograms, by bioimpedance spectroscopy, changes from baseline.	Eight weeks
Fat Mass.	Measured in kilograms, by bioimpedance spectroscopy, changes from baseline.	Eight weeks
Fluid Balance.	Measured in kilograms, by bioimpedance spectroscopy, changes from baseline.	Eight weeks
Changes in protein intake.	Measured in gram, by a standardized interview with examples of pictures to determine serving size, from baseline.	Eight weeks
Compliance of recommended changes.	Measured by score through interview. Minimum score 1 and maximum score 5. The greater the score, the better compliance.	Eight weeks

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: University of Copenhagen
• Investigators: Principal Investigator: Jesper Fabricius, Ph.d., Hammel neurorehabilitation centre and university research clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2021
• Primary Completion (Actual): October 17, 2021
• Study Completion (Actual): December 9, 2021

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (Actual): December 7, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Dysphagia; Dietary Guidance; Energy- and Protein intake; Food Texture; Activities of Daily Living and Quality of Life
• Other Study ID Numbers: MS19953

Drug and device information, study documents

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