Quality of Life Clinical Trial
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
NCT number | NCT04655547 |
Other study ID # | MS19953 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 8, 2021 |
Est. completion date | December 9, 2021 |
Verified date | August 2021 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 13 |
Est. completion date | December 9, 2021 |
Est. primary completion date | October 17, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Hammel Neurorehabilitation Centre and University Research Clinic | Hammel | Midtjylland |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | University of Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 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. | Eight weeks | |
Secondary | Body Weight. | Measured in kilograms, by bioimpedance spectroscopy, changes from baseline. | Eight weeks | |
Secondary | Lean Body Mass. | Measured in kilograms, by bioimpedance spectroscopy, changes from baseline. | Eight weeks | |
Secondary | Fat Mass. | Measured in kilograms, by bioimpedance spectroscopy, changes from baseline. | Eight weeks | |
Secondary | Fluid Balance. | Measured in kilograms, by bioimpedance spectroscopy, changes from baseline. | Eight weeks | |
Secondary | Changes in protein intake. | Measured in gram, by a standardized interview with examples of pictures to determine serving size, from baseline. | Eight weeks | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
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