Clinical trial NCT06530979: The Effectiveness of a Tailored Nutritional Education Program on Profound Hearing Impairment Adults
Official title: The Effectiveness of a Tailored Nutritional Education Program Utilizing Saudi-Sign Language on Adults With Profound Hearing Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Profound Hearing Impairment
Nutrition, Healthy
Keywords: Profound hearing impairment
Nutrition knowledge
Nutrition status
Intervention nutrition education
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Nutrition knowledge
timeFrame: 3 months
measure: Anthropometric measurements
timeFrame: 3 months
measure: Body composition measurement
timeFrame: 3 months
measure: Dietary assessment
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: College of Applied Medical Sciences
Study officials:
affiliation: King Saud University
name: Jenan Aljubair, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: