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NCT Number: NCT04655547

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

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.

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Key information

Conditions

Energy Intake Activities of Daily Living Body Weight Deglutition Disorders Digestive System Diseases Esophageal Diseases Fat Mass Fluid Balance Gastrointestinal Diseases Lean Body Mass Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Protein Intake Quality of Life Signs and Symptoms Weight

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hammel Neurorehabilitation Centre and University Research Clinic

Hammel, Central Jutland, 8450, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary guidance

Other

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

Primary outcomes

  1. Changes in energy intake, from baseline.

    Time frame: 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 outcomes

  1. Changes in Dysphagia Handicap Index (DHI) total and section (E and F) score.

    Time frame: 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.

  2. In how many questions in the DHI, does the intervention group change the score in relation to the control group, and with how much.

    Time frame: Eight weeks

    Measured in points, changes from baseline.

  3. Body Weight.

    Time frame: Eight weeks

    Measured in kilograms, by bioimpedance spectroscopy, changes from baseline.

  4. Lean Body Mass.

    Time frame: Eight weeks

    Measured in kilograms, by bioimpedance spectroscopy, changes from baseline.

  5. Fat Mass.

    Time frame: Eight weeks

    Measured in kilograms, by bioimpedance spectroscopy, changes from baseline.

  6. Fluid Balance.

    Time frame: Eight weeks

    Measured in kilograms, by bioimpedance spectroscopy, changes from baseline.

  7. Changes in protein intake.

    Time frame: Eight weeks

    Measured in gram, by a standardized interview with examples of pictures to determine serving size, from baseline.

  8. Compliance of recommended changes.

    Time frame: Eight weeks

    Measured by score through interview. Minimum score 1 and maximum score 5. The greater the score, the better compliance.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • University of Copenhagen

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 7, 2020
Registry last updated
Dec 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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