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

Not Applicable

Completed

• Conditions: Energy Intake; Activities of Daily Living; Quality of Life; Weight; Protein Intake; Lean Body Mass; Fat Mass; Fluid Balance
• Interventions: Other: Dietary guidance

• Registration Number: NCT04655547
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-12-04
• Study First Posted: 2020-12-07
• Study Start: 2021-03-08
• Status Verified: 2021-08
• Primary Completion: 2021-10-17
• Study Completion: 2021-12-09
• Last Update Submitted: 2021-12-16
• Last Update Posted: 2021-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Dietary guidance	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Fat Mass.	Eight weeks	Measured in kilograms, by bioimpedance spectroscopy, changes from baseline.
Lean Body Mass.	Eight weeks	Measured in kilograms, by bioimpedance spectroscopy, changes from baseline.
Compliance of recommended changes.	Eight weeks	Measured by score through interview. Minimum score 1 and maximum score 5. The greater the score, the better compliance.
Changes in Dysphagia Handicap Index (DHI) total and section (E and F) score.	Eight weeks	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.
Changes in protein intake.	Eight weeks	Measured in gram, by a standardized interview with examples of pictures to determine serving size, from baseline.
In how many questions in the DHI, does the intervention group change the score in relation to the control group, and with how much.	Eight weeks	Measured in points, changes from baseline.
Fluid Balance.	Eight weeks	Measured in kilograms, by bioimpedance spectroscopy, changes from baseline.
Body Weight.	Eight weeks	Measured in kilograms, by bioimpedance spectroscopy, changes from baseline.

Trial Locations

Locations (1)

Hammel Neurorehabilitation Centre and University Research Clinic; 🇩🇰 Hammel, Midtjylland, Denmark