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

NCT04655547 | Completed

• 1 other identifier: MS19953
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Dysphagia; Dietary Guidance; Energy- and Protein intake; Food Texture; Activities of Daily Living and Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Changes in Dysphagia Handicap Index (DHI) total and section (E and F) score.

  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.

  Eight weeks

• Body Weight.

  Eight weeks

• Lean Body Mass.

  Eight weeks

• Fat Mass.

  Eight weeks

Study Arms (2)

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.

Other: Dietary guidance

Interventions

Dietary guidance OTHER

Dietary guidance with focus on texture and energy intake, preformed by certified dietitians.

Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Individuals with known eating disorders
• Ineligible individuals
• Individual in need of translator
• Individuals participating in another trial

Sponsors & Collaborators

• University of Aarhus: lead
• University of Copenhagen: collaborator

Study Sites (1)

Hammel Neurorehabilitation Centre and University Research Clinic

Hammel, Central Jutland, 8450, Denmark

Location

MeSH Terms

Conditions

Body Weight; Deglutition Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Jesper Fabricius, Ph.d.

  Hammel Neurorehabilitation Centre and University Research Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to control or intervention group, stratified on their FEDSS-score. The study will include 34 participants - 17 in each group.

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 7, 2020
• Study Start: March 8, 2021
• Primary Completion: October 17, 2021
• Study Completion: December 9, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-08

Locations

DK (1)