Impact on Energy Intake by Implementing Recommended Food Texture Through Dietary Guidance

University of Aarhus

Status: Completed

Conditions: Lean Body Mass; Energy Intake; Quality of Life; Protein Intake; Fat Mass; Activities of Daily Living; Weight; Fluid Balance

Treatments: Other: Dietary guidance

Study type: Interventional

Funder types: Other

Identifiers

NCT04655547

MS19953

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Control

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Dietary guidance