Energy Intake, Activities of Daily Living, Quality of Life, Protein Intake, Fluid Balance, Lean Body Mass, Fat Mass, Weight
Conditions
Keywords
Dysphagia, Dietary Guidance, Energy- and Protein intake, Food Texture, Activities of Daily Living and Quality of Life
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.
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.
Interventions
OTHERDietary guidance
Dietary guidance with focus on texture and energy intake, preformed by certified dietitians.
Sponsors
University of Copenhagen
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in energy intake, from baseline. | 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
| Measure | Time frame | Description |
|---|---|---|
| In how many questions in the DHI, does the intervention group change the score in relation to the control group, and with how much. | Eight weeks | Measured in points, changes from baseline. |
| Body Weight. | Eight weeks | Measured in kilograms, by bioimpedance spectroscopy, changes from baseline. |
| Lean Body Mass. | Eight weeks | Measured in kilograms, by bioimpedance spectroscopy, changes from baseline. |
| Changes in Dysphagia Handicap Index (DHI) total and section (E and F) score. | 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. |
| Fluid Balance. | Eight weeks | Measured in kilograms, by bioimpedance spectroscopy, changes from baseline. |
| Changes in protein intake. | Eight weeks | Measured in gram, by a standardized interview with examples of pictures to determine serving size, from baseline. |
| Compliance of recommended changes. | Eight weeks | Measured by score through interview. Minimum score 1 and maximum score 5. The greater the score, the better compliance. |
| Fat Mass. | Eight weeks | Measured in kilograms, by bioimpedance spectroscopy, changes from baseline. |
Countries
Denmark
Outcome results
None listed