Investigating Program of Food Preparation on Diet Improvement for Patients With Stroke

April 13, 2020 updated by: Taiwan Adventist Hospital
This is a randomized controlled behavioral intervention trial to assess the efficacy of investigating program of food preparation on diet improve patients with stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized controlled behavioral intervention trial to assess the efficacy of investigating program of food preparation on diet improve patients with stroke. Subjects will be randomized to intervention group and control group.The primary outcome included seven measures, Functional oral intake scale, Mini Nutritional Assessment, Council on Nutrition Appetite Questionnaire, Dietary Well-Being Scale, Swallowing Quality of Life questionnaire, WHO Quality of Life-BREF and Eating Assessment Tool-10.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Beitou Dist
      • Taipei City, Beitou Dist, Taiwan, 12303
        • National Taipei University of Nursing and Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis is stroke
  • EAT-10 ≥ 3
  • Aged > 20 years
  • Capability of following instructions
  • Willing to participants to the study

Exclusion Criteria:

  • Non-stroke neurological diseases ( ex: traumatic brain injury, brain tumor, neurodegenerative disease and Parkinson's disease )
  • Dysphagia by neck injury or surgery
  • During the study, he/she was hospitalized again due to disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
No Intervention
Experimental: Experimental group
Group swallowing disorder diet preparation program
Other: Group swallowing disorder diet preparation program
This program included food properties, select food, type of cooking, using thickener and tasting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of the Eating Assessment Tool-10
Time Frame: 6 weeks
Eating Assessment Tool-10 assesses ability of swallowing by myself. The total scare ranges from 0-40. A higher level indicates better ability of swallowing. Changes of the Eating Assessment Tool-10 will be assessed before and after intervention.
6 weeks
Changes of the Functional Oral Intake Scale
Time Frame: 6 weeks
Functional Oral Intake Scale assesses ability of swallowing. The total level ranges from 1-7. A higher level indicates better ability of swallowing. Changes of the Functional Oral Intake Scale will be assessed before and after intervention.
6 weeks
Changes of the Mini Nutritional Assessment
Time Frame: 6 weeks
Mini Nutritional Assessment assesses comprehensive nutritional. The total score ranges from 0-30. A higher score indicates better nutrition status. Changes of the Mini Nutritional Assessment will be assessed before and after intervention.
6 weeks
Changes of the Council on Nutrition Appetite Questionnaire
Time Frame: 6 weeks
Council on Nutrition Appetite Questionnaire assesses appetite.The total score ranges from 8-40. A higher score indicates better appetite. Changes of the Council on Nutrition Appetite Questionnaire will be assessed before and after intervention.
6 weeks
Changes of the Dietary Well-Being Scale
Time Frame: 6 weeks
Dietary Well-Being Scale assesses dietary well-being. The total scare ranges from 21-126. A higher score indicates better dietary well-being. Changes of the Dietary Well-Being Scale well be assessed before and after intervention.
6 weeks
Changes of the Swallowing Quality of Life questionnaire
Time Frame: 6 weeks
Swallowing Quality of Life questionnaire assesses quality of life about swallowing.The total score ranges from 44-220. A higher score indicates better quality of life about swallowing. Changes of the Swallowing Quality of Life questionnaire well be assessed before and after intervention.
6 weeks
Changes of the WHO Quality of Life-BREF
Time Frame: 6 weeks
WHO Quality of Life-BREF assesses quality of life. The total score ranges from 28-140. A higher score indicates better quality of life. Changes of the WHO Quality of Life-BREF well be assessed before and after intervention.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taiwan Adventist Hospital

Investigators

  • Study Director: En-Chi Chiu, PhD, National Taipei University of Nursing and Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2018

Primary Completion (Actual)

September 28, 2018

Study Completion (Actual)

September 28, 2018

Study Registration Dates

First Submitted

April 13, 2020

First Submitted That Met QC Criteria

April 13, 2020

First Posted (Actual)

April 15, 2020

Study Record Updates

Last Update Posted (Actual)

April 15, 2020

Last Update Submitted That Met QC Criteria

April 13, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 106-E-29

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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