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NCT Number: NCT06530979

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

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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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

Device

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

Primary outcomes

  1. 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).

  2. 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. Body composition measurement

    Time frame: 3 months

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

  4. Dietary assessment

    Time frame: 3 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

0552206637

Jenan Aljubair, Ph.D.

CONTACT

[email protected]

0504253871

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 31, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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