The Effectiveness of a Tailored Nutritional Education Program on Profound Hearing Impairment Adults

July 29, 2024 updated by: Jenan Aljubair, King Saud University

The Effectiveness of a Tailored Nutritional Education Program Utilizing Saudi-Sign Language on Adults With Profound Hearing Impairment

Literature suggests that profound hearing-impaired people have poor access to health care directly related to communication difficulties. A lack of knowledge regarding health and healthy dietary patterns has been documented. Several associations between chronic diseases such as obesity, CVD, hyperlipidemia etc., and hearing impairments have been established. There is a gap in the literature for studies that use Saudi-sign language-tailored programs in patient health and nutrition education.

This project aims to create a Saudi-sign language general nutritional education program and then test its effectiveness in enhancing the nutritional status and knowledge of Saudis with profound hearing impairments.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Literature suggests that profound hearing-impaired people have poor access to health care directly related to communication difficulties. A lack of knowledge regarding health and healthy dietary patterns has been documented. Several associations between chronic diseases such as obesity, CVD, hyperlipidemia etc., and hearing impairments have been established. There is a gap in the literature for studies that use Saudi-sign language-tailored programs in patient health and nutrition education.

This project aims to create a Saudi-sign language general nutritional education program and then test its effectiveness in enhancing the nutritional status and knowledge of Saudis with profound hearing impairments.

Methods: The study will be divided into two phases. The first phase will cultural adaptation and translation of the General Nutrition Knowledge Questionnaire (GNKQ) which will be used in the intervention study. In this phase, the forward-backwards technique will be followed, for internal consistency will be used Cronbach's alpha. A Saudi-sign language general nutritional education program will be created from accredible source for content appropriateness. For the second phase, the interventional study, the participants will be randomly selected and allocated to either the control or the experimental group. The efficacy of the Saudi-sign language general nutrition education program to enhance the knowledge and nutrition health of Saudi adults with profound hearing impairment will be compared to a control group. A small group counselling will be delivered to the experimental group using pictures, animated films, models, and Saudi-sign language translations supplied by a sign language interpreter in the videos and person during sessions. The same video will be used to create PowerPoint with nutritional education information for the control group in Arabic. Anthropometric data, body composition, a 3-day food diary, and the GNKQ will all be gathered at baseline and twelve weeks later.

Study Type

Interventional

Enrollment (Estimated)

61

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 Contact

Study Contact Backup

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Saudi adults
  2. Aged between 18-65 years
  3. Both males and females
  4. Known case of profound hearing impairment /disability
  5. knowledgeable in Saudi Sign Language.

Exclusion Criteria:

  1. Aged <18 years
  2. Not knowing the Saudi Sign Language
  3. Other disabilities such as mental or physical disability
  4. Have nutritional knowledge such as attended course/s related nutrition or studied in nutrition field
  5. Illiterate
  6. Pregnant or planning a pregnancy, or on breastfeeding

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutritional education program intervention
Nutritional education program intervention (NEP group n=30) profound hearing-impaired people who will receive tailored nutritional education program intervention utilizing Saudi-Sign Language supplied by a sign language interpreter in the videos and person during sessions.
Device: Tailored nutritional education program utilizing Saudi-sign language supplied by Saudi-sign language interpreter
The program will be implemented in an experimental group composed of profoundly impaired hearing adults (91 Decibels and above). The experimental group will receive nutrition group counselling via photos, and models, and Saudi-sign language interpreter, including awareness of food groups and their nutrients, choose healthy and balanced items from supermarkets, restaurants or coffee shop menus-traffic lights on nutrition labelling and health problems or diseases related to diet and weight management
No Intervention: Control
Control (C group n=31) Profound hearing-impaired people who will non- receive tailored nutritional education program intervention utilizing Saudi-Sign Language

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutrition knowledge
Time Frame: 3 months
General Nutrition Knowlege Questionnaire GNKQ as videos used Saudi Sign language (Multiple-choice questions with a single select multiple choice question).
3 months
Anthropometric measurements
Time Frame: 3 months
Anthropometric measurements (e.g., weight and height will be combined to report BMI in kg/m^2), (Wist and hip circumference will be combined to report Wist/Hip ratio).
3 months
Body composition measurement
Time Frame: 3 months
Body composition measurement via Tanita to measure (FM, FFM, Muscle mass in Kg and TBW %).
3 months
Dietary assessment
Time Frame: 3 months
A 3-day food record diary (two days weekday and one day weekend).
3 months

Collaborators and Investigators

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

Sponsor

King Saud University

Investigators

  • Principal Investigator: Jenan Aljubair, Ph.D, King Saud University

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)

June 1, 2023

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

March 2, 2025

Study Registration Dates

First Submitted

July 8, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

July 31, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • kingSaudU1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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