NCT06530979

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2025

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

1.5 years

First QC Date

July 8, 2024

Last Update Submit

July 29, 2024

Conditions

Profound Hearing ImpairmentNutrition, Healthy

Keywords

Profound hearing impairmentNutrition knowledgeNutrition statusIntervention nutrition education

Outcome Measures

Primary Outcomes (4)

  • Nutrition knowledge

    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

    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

    Body composition measurement via Tanita to measure (FM, FFM, Muscle mass in Kg and TBW %).

    3 months

  • Dietary assessment

    A 3-day food record diary (two days weekday and one day weekend).

    3 months

Study Arms (2)

Nutritional education program intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Control (C group n=31) Profound hearing-impaired people who will non- receive tailored nutritional education program intervention utilizing Saudi-Sign Language

Interventions

Tailored nutritional education program utilizing Saudi-sign language supplied by Saudi-sign language interpreterDEVICE

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

Nutritional education program intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Applied Medical Sciences

Riyadh, 11433, Saudi Arabia

RECRUITING

Study Officials

  • Jenan Aljubair, Ph.D

    King Saud University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenan Aljubair, Ph.D.

CONTACT

0504253871442204508@student.ksu.edu.sa

Dara Aldisi, M.D., Ph.D.

CONTACT

0552206637daldisi@ksu.edu.sa

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 8, 2024

First Posted

July 31, 2024

Study Start

June 1, 2023

Primary Completion

November 30, 2024

Study Completion

March 2, 2025

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)