Energy IntakeNCT04655547
Impact on Energy Intake by Implementing Recommended Food Texture Through Dietary Guidance
A study testing Dietary guidance in people with Energy Intake and Activities of Daily Living, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Energy Intake, Activities of Daily Living, Quality of Life
- What is being tested?
- Dietary guidance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Mar 2021to 9 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Individuals with known eating disorders
- Ineligible individuals
- Individual in need of translator
- Individuals participating in another trial
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Hammel Neurorehabilitation Centre and University Research Clinic
Hammel, Central Jutland, 8450
About this study
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
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.
Read the 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.
- Conditions
- Energy Intake, Activities of Daily Living, Quality of Life, Protein Intake, Fluid Balance, Lean Body Mass
- Being tested
- Dietary guidance
- Keywords
- Dysphagia, Dietary Guidance, Energy- and Protein intake, Food Texture, Activities of Daily Living and Quality of Life
- Medical subject headings
- Body Weight, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary guidanceOther
Dietary guidance with focus on texture and energy intake, preformed by certified dietitians.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| Intervention | Experimental | 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. Receives: Other: Dietary guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Eight weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: Eight weeks
Body Weight.
Measured in kilograms, by bioimpedance spectroscopy, changes from baseline.
Measured: Eight weeks
Lean Body Mass.
Measured in kilograms, by bioimpedance spectroscopy, changes from baseline.
Measured: Eight weeks
Fat Mass.
Measured in kilograms, by bioimpedance spectroscopy, changes from baseline.
Measured: Eight weeks
Fluid Balance.
Measured in kilograms, by bioimpedance spectroscopy, changes from baseline.
Measured: Eight weeks
Changes in protein intake.
Measured in gram, by a standardized interview with examples of pictures to determine serving size, from baseline.
Measured: 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.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start8 Mar 2021
- Primary completion17 Oct 2021
- Study completion9 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy IntakeStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor
- Investigators
- Jesper Fabricius, Ph.d., Principal investigator, Hammel Neurorehabilitation Centre and University Research Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655547
- Sponsor's protocol ID
- MS19953
- Status last verified
- Aug 2021
- First submitted
- 24 Nov 2020
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04655547
- Acronym / sponsor ID
- MS19953
- Conditions
- Energy Intake, Activities of Daily Living, Quality of Life, Protein Intake, Fluid Balance, Lean Body Mass
- Keywords
- Dysphagia, Dietary Guidance, Energy- and Protein intake, Food Texture, Activities of Daily Living and Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 17 Oct 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| Intervention | Experimental | Other: Dietary guidanceThe 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (4 listed)
- Individuals with known eating disorders
- Ineligible individuals
- Individual in need of translator
- Individuals participating in another trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary guidanceDietary guidance with focus on texture and energy intake, preformed by certified dietitians. | Other | Intervention |
Primary outcome
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.
8 secondary outcomes
Changes in Dysphagia Handicap Index (DHI) total and section (E and F) score.
Time frame: 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.
Time frame: Eight weeks
Body Weight.
Time frame: Eight weeks
Lean Body Mass.
Time frame: Eight weeks
Fat Mass.
Time frame: Eight weeks
Fluid Balance.
Time frame: Eight weeks
Changes in protein intake.
Time frame: Eight weeks
Compliance of recommended changes.
Time frame: Eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesper Fabricius, Ph.d. principal investigator
Hammel Neurorehabilitation Centre and University Research Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary guidance in people with Energy Intake and Activities of Daily Living, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in energy intake, from baseline. (time frame: Eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.