Profound Hearing ImpairmentNCT06530979
The Effectiveness of a Tailored Nutritional Education Program on Profound Hearing Impairment Adults
A study testing Tailored nutritional education program utilizing Saudi-sign language supplied by Saudi-sign language interpreter in people with Profound Hearing Impairment and Nutrition, Healthy, run by King Saud University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Profound Hearing Impairment, Nutrition, Healthy
- What is being tested?
- Tailored nutritional education program utilizing Saudi-sign language supplied by Saudi-sign language interpreter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jun 2023to 2 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Saudi adults
- Aged between 18-65 years
- Both males and females
- Known case of profound hearing impairment /disability
- knowledgeable in Saudi Sign Language.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
College of Applied Medical Sciences
Riyadh, 11433
Jenan Aljubair, Ph.D., 0504253871, 442204508@student.ksu.edu.sa
Dara Aldisi, M.D., Ph.D., 0552206637, daldisi@ksu.edu.sa
About this study
Official title: 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.
Read the 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.
- Conditions
- Profound Hearing Impairment, Nutrition, Healthy
- Being tested
- Tailored nutritional education program utilizing Saudi-sign language supplied by Saudi-sign language interpreter
- Keywords
- Profound hearing impairment, Nutrition knowledge, Nutrition status, Intervention nutrition education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutrition knowledge
General Nutrition Knowlege Questionnaire GNKQ as videos used Saudi Sign language (Multiple-choice questions with a single select multiple choice question).
Measured: 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).
Measured: 3 months
Body composition measurement
Body composition measurement via Tanita to measure (FM, FFM, Muscle mass in Kg and TBW %).
Measured: 3 months
Dietary assessment
A 3-day food record diary (two days weekday and one day weekend).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Jun 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion2 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Profound Hearing ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenan Aljubair, King Saud University
- Investigators
- Jenan Aljubair, Ph.D, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530979
- Sponsor's protocol ID
- kingSaudU1
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Tailored Nutritional Education Program Utilizing Saudi-Sign Language on Adults With Profound Hearing Impairment
- ClinicalTrials.gov ID
- NCT06530979
- Acronym / sponsor ID
- kingSaudU1
- Conditions
- Profound Hearing Impairment, Nutrition, Healthy
- Keywords
- Profound hearing impairment, Nutrition knowledge, Nutrition status, Intervention nutrition education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 2 Mar 2025 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional education program intervention | Experimental | Device: Tailored nutritional education program utilizing Saudi-sign language supplied by Saudi-sign language interpreterNutritional 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. |
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Saudi adults
- Aged between 18-65 years
- Both males and females
- Known case of profound hearing impairment /disability
- knowledgeable in Saudi Sign Language.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored nutritional education program utilizing Saudi-sign language supplied by Saudi-sign language interpreterThe 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 | Device | Nutritional education program intervention |
Primary outcome
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).
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).
Body composition measurement
Time frame: 3 months
Body composition measurement via Tanita to measure (FM, FFM, Muscle mass in Kg and TBW %).
Dietary assessment
Time frame: 3 months
A 3-day food record diary (two days weekday and one day weekend).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Profound Hearing Impairment
Recruiting
Optimization of Hearing Performance in the Subject Implanted
Hearing Loss
Not yet recruitingPhase 2
Efficacy and Safety of Intracochlear Injection of Glucocorticoid Through the Round Window Membrane in Patients With Profound or Complete Sudden Sensorineural Hearing Loss
Sudden Hearing Loss
Not yet recruitingObservational study
Retrospective Analysis of Performance and Safety of MED-EL Cochlear Implants.
Severe to Profound Hearing Loss
Recruiting
Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in fNIRS
Deafness
Active, not recruitingPhase 1/2
A Phase I/II Clinical Trial With SENS-501 in Children Suffering From Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations
OTOF Gene Mutation, DFNB9
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenan Aljubair, Ph.D principal investigator
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored nutritional education program utilizing Saudi-sign language supplied by Saudi-sign language interpreter in people with Profound Hearing Impairment and Nutrition, Healthy, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jenan Aljubair, Ph.D. (0504253871, 442204508@student.ksu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutrition knowledge (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.