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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary guidance | Other | Dietary guidance with focus on texture and energy intake, preformed by certified dietitians. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| In how many questions in the DHI, does the intervention group change the score in relation to the control group, and with how much. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesper Fabricius, Ph.d. | Hammel Neurorehabilitation Centre and University Research Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammel Neurorehabilitation Centre and University Research Clinic | Hammel | Central Jutland | 8450 | Denmark |
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| ID | Term |
|---|---|
| D001835 | Body Weight |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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Participants will be randomized to control or intervention group, stratified on their FEDSS-score.
The study will include 34 participants - 17 in each group.
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Measured in points, changes from baseline. |
| Eight weeks |
| Body Weight. | Measured in kilograms, by bioimpedance spectroscopy, changes from baseline. | Eight weeks |
| Lean Body Mass. | Measured in kilograms, by bioimpedance spectroscopy, changes from baseline. | Eight weeks |
| Fat Mass. | Measured in kilograms, by bioimpedance spectroscopy, changes from baseline. | Eight weeks |
| Fluid Balance. | Measured in kilograms, by bioimpedance spectroscopy, changes from baseline. | Eight weeks |
| Changes in protein intake. | Measured in gram, by a standardized interview with examples of pictures to determine serving size, from baseline. | 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. | Eight weeks |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |