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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04655547
• Other study ID #: MS19953
• Status: Completed
• Phase: N/A
• Start date: March 8, 2021
• Est. completion date: December 9, 2021

Study information

• Verified date: August 2021
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 9, 2021
• Est. primary completion date: October 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Activities of Daily Living
• Energy Intake
• Fat Mass
• Fluid Balance
• Lean Body Mass
• Protein Intake
• Quality of Life
• Weight

Intervention

Other:
• Dietary guidance
Dietary guidance with focus on texture and energy intake, preformed by certified dietitians.

Locations

Country	Name	City	State
Denmark	Hammel Neurorehabilitation Centre and University Research Clinic	Hammel	Midtjylland

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Body Weight.	Measured in kilograms, by bioimpedance spectroscopy, changes from baseline.	Eight weeks
Secondary	Lean Body Mass.	Measured in kilograms, by bioimpedance spectroscopy, changes from baseline.	Eight weeks
Secondary	Fat Mass.	Measured in kilograms, by bioimpedance spectroscopy, changes from baseline.	Eight weeks
Secondary	Fluid Balance.	Measured in kilograms, by bioimpedance spectroscopy, changes from baseline.	Eight weeks
Secondary	Changes in protein intake.	Measured in gram, by a standardized interview with examples of pictures to determine serving size, from baseline.	Eight weeks
Secondary	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