Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04655547
Status:
COMPLETED
Last Update Posted:
2021-12-17
First Post:
2020-11-24
Brief Title:
Impact on Energy Intake by Implementing Recommended Food Texture Through Dietary Guidance
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 difficultiesknown 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None