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

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ClinicalTrials.gov Identifier: NCT04655547
Recruitment Status : Completed
First Posted : December 7, 2020
Last Update Posted : December 17, 2021
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
University of Aarhus

Study Description
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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.


Condition or disease Intervention/treatment Phase
Energy Intake Activities of Daily Living Quality of Life Protein Intake Fluid Balance Lean Body Mass Fat Mass Weight Other: Dietary guidance Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : March 8, 2021
Actual Primary Completion Date : October 17, 2021
Actual Study Completion Date : December 9, 2021
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04655547


Locations
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Denmark
Hammel Neurorehabilitation Centre and University Research Clinic
Hammel, Midtjylland, Denmark, 8450
Sponsors and Collaborators
University of Aarhus
University of Copenhagen
Investigators
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Principal Investigator: Jesper Fabricius, Ph.d. Hammel Neurorehabilitation Centre and University Research Clinic
More Information
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04655547    
Other Study ID Numbers: MS19953
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: December 17, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
Dysphagia
Dietary Guidance
Energy- and Protein intake
Food Texture
Activities of Daily Living and Quality of Life