- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06836336
Digital Versus Hybrid Interventions in Promoting Nutrition Knowledge Among Saudi Adolescent Girls
February 17, 2025 updated by: Essra Noorwali, Umm Al-Qura University
Effectiveness of Digital Versus Hybrid Interventions in Promoting Nutrition Knowledge Among Adolescent Girls: A Randomized Trial
This study primarily aims to compare the efficacy of different approaches to nutrition education intervention delivery in improving nutrition knowledge (NK) among Saudi adolescent girls.
A secondary aim is to compare the effectiveness of these interventions in enhancing dietary habits and reducing Generalized Anxiety Disorder (GAD) scores.A randomized sample of 104 Saudi adolescent girls aged 16-18 years from a single high school in Makkah city enrolled in a 4-week lifestyle educational intervention for health promotion.
Participants were randomly assigned to either a hybrid or a fully digital nutritional education program.
Outcome measures included knowledge (NK), dietary and lifestyle habits assessed by the Healthy Plate Variety Score (HPVS), and mental health evaluated using the Generalized Anxiety Disorder (GAD) scores.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
104
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 Locations
-
-
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Mecca, Saudi Arabia
- Al-Fatat Private School
-
-
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
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy
- Adolescents (15-19 years old)
- Reliable internet access
- Willing to participate
Exclusion Criteria:
- Has chronic disease/s
- <15 years and >19 years
- No internet access
- Not willing to participate
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hybrid intervention
Hybrid intervention that combined face-to-face educational sessions with the integration of technological advancements.
|
Hybrid intervention that combined face-to-face educational sessions with the integration of technological advancements.
They attended weekly 40-minute interactive educational sessions over the course of a month.
The educational materials encompass information regarding the components of a healthy balanced diet and an active lifestyle.Throughout the intervention, participants were provided with a range of behavior change techniques to support participants in applying the educational content to improve their dietary and lifestyle habits.
The employed behavior change techniques were SMART (specific, measurable, achievable, relevant, time-bound) goal setting, reviewing behavioral goals, problem-solving and environmental restructuring.
The technological support for this intervention included the use of a smartphone diet tracker app called MyFitneesPal as well as communication with the interventionists via WhatsApp.
|
|
Experimental: Fully digital intervention
Received the same educational materials as the hybrid intervention group through WhatsApp twice a week over the course of one month.
|
Fully digital intervention, where they received the same educational materials through WhatsApp twice a week over the course of one month.
The educational materials were presented through easily understandable posters, brief videos, and followed by short quizzes to reinforce the acquired knowledge.
Additionally, the digital intervention incorporated the same behavior change strategies that were utilized in the hybrid group.
Participants were also introduced to MyFittnessPal application in order to help them track their dietary habits and monitor their progress since it is considered a tool for self-monitoring and promoting healthy dietary behaviors throughout the intervention period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nutrition knowledge
Time Frame: From enrollment to the end of treatment at 4 weeks
|
Nutritional Knowledge was assessed using a validated dietary questionnaire, distributed in Arabic (24).
The questionnaire comprised 10 items, with a maximum score of 10 points.
Each correct response was awarded 1 point, while incorrect answers or uncertain responses received a score of zero.
The final score was derived by summing the total points.
To classify NK levels, modified Bloom's cut-off points were employed: a score of 80-100% (8-10 points) indicated good NK, 50-79% (5-7.9 points) represented moderate knowledge, and scores below 50% (<5 points) denoted low knowledge.
For analytical purposes, these categories were dichotomized into satisfactory NK (>80% correct) and unsatisfactory NK (<80% correct) (7,25).
|
From enrollment to the end of treatment at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Generalized Anxiety Disorder Scores (GAD)
Time Frame: From enrollment to the end of treatment at 4 weeks
|
Anxiety levels were measured using the GAD-7.
This is a 7-item validated questionnaire (28), which is widely used to screen for and quantify the severity of GAD.
The Arabic version of this tool has been adopted by the Saudi Arabian Ministry of Health for initial anxiety screening.
Each item is rated on a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 21.
Higher scores reflect greater anxiety levels.
Anxiety was defined using a cutoff score of 10 or above, which differentiated between minimal to mild anxiety and moderate to severe anxiety (28).
|
From enrollment to the end of treatment at 4 weeks
|
|
Dietary habits
Time Frame: From enrollment to the end of treatment at 4 weeks
|
Dietary habits were evaluated using a questionnaire adapted from research on food consumption frequencies in Qatar, which share similar characteristics with Saudi Arabia.
The questionnaire assessed the frequency of consumption of various food groups, including vegetables, fruits, carbohydrates (e.g., bread, rice, pasta), proteins (e.g., chicken, beef, fish), and dairy products (e.g.
yoghurt and cheese).
Participants responded to questions such as, "How often do you consume fresh fruits/green leafy vegetables/fish?
To evaluate dietary variety, the study employed the Healthy Plate Variety Score, calculated using a modified methodology based on Jones et al. (2015).
This approach involved dichotomizing food intake from the five main groups into two categories (daily intake vs. non-daily).
Foods consumed daily received a score of 1, while those not consumed daily received a score of 0 with a potential maximum score of 5.0.
|
From enrollment to the end of treatment at 4 weeks
|
|
Anthropometric measurements (Body mass index)
Time Frame: From enrollment to the end of treatment at 4 weeks
|
Body measurements were obtained using standardized equipment following established operating procedures.
Trained senior dietitians objectively assessed the height and weight of adolescents using a mechanical combined scale and a stadiometer (Detecto).
Prior to measurement, a technician ensured that the equipment was properly calibrated.
Height was recorded to the nearest 0.1 cm while participants were barefoot and dressed in minimal clothing.
Weight was measured and documented to the nearest 0.1 kg.
The Body Mass Index (BMI) was calculated by dividing the weight in kilograms by the square of the height in meters.
Weight status was classified according to the criteria set by the World Health Organization (WHO): underweight was defined as a BMI of less than 18.5 kg/m², normal weight ranged from 18.5 to 24.9 kg/m², overweight was categorized as a BMI between 25.0 and 29.9 kg/m², and obesity was indicated by a BMI of 30.0 kg/m² or higher.
|
From enrollment to the end of treatment at 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mai A Ghabashi, PhD, Umm Al-Qura University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Das JK, Salam RA, Thornburg KL, Prentice AM, Campisi S, Lassi ZS, Koletzko B, Bhutta ZA. Nutrition in adolescents: physiology, metabolism, and nutritional needs. Ann N Y Acad Sci. 2017 Apr;1393(1):21-33. doi: 10.1111/nyas.13330.
- Ashton LM, Sharkey T, Whatnall MC, Williams RL, Bezzina A, Aguiar EJ, Collins CE, Hutchesson MJ. Effectiveness of Interventions and Behaviour Change Techniques for Improving Dietary Intake in Young Adults: A Systematic Review and Meta-Analysis of RCTs. Nutrients. 2019 Apr 11;11(4):825. doi: 10.3390/nu11040825.
- Hargreaves D, Mates E, Menon P, Alderman H, Devakumar D, Fawzi W, Greenfield G, Hammoudeh W, He S, Lahiri A, Liu Z, Nguyen PH, Sethi V, Wang H, Neufeld LM, Patton GC. Strategies and interventions for healthy adolescent growth, nutrition, and development. Lancet. 2022 Jan 8;399(10320):198-210. doi: 10.1016/S0140-6736(21)01593-2. Epub 2021 Nov 29.
- Charles Shapu R, Ismail S, Ahmad N, Lim PY, Abubakar Njodi I. Systematic Review: Effect of Health Education Intervention on Improving Knowledge, Attitudes and Practices of Adolescents on Malnutrition. Nutrients. 2020 Aug 13;12(8):2426. doi: 10.3390/nu12082426.
- Bany-Yasin H, Elmor AA, Ebrahim BK, Ahmed AAM, Alarachi MR, Abedalqader L, Amer R, Alyousef AMS, Alhajeh YF, Alyoussef A, Eid HAMA, Elsayed MM, Desouky EDE, Salem HK, Salem MR. Exploration of the nutrition knowledge among general population: multi-national study in Arab countries. BMC Public Health. 2023 Jun 19;23(1):1178. doi: 10.1186/s12889-023-15791-9.
- Saha S, Okafor H, Biediger-Friedman L, Behnke A. Association between diet and symptoms of anxiety and depression in college students: A systematic review. J Am Coll Health. 2023 May-Jun;71(4):1270-1280. doi: 10.1080/07448481.2021.1926267. Epub 2021 Jun 4.
- Lwin EZ, Watthanakulpanich D, Phetrak A, Soonthornworasiri N, Prangthip P. Factors influencing secondary school students' nutrition, mindfulness, and academic performance in Nan Province, Thailand. PLoS One. 2025 Jan 14;20(1):e0308882. doi: 10.1371/journal.pone.0308882. eCollection 2025.
- Hamulka J, Czarniecka-Skubina E, Gutkowska K, Drywien ME, Jeruszka-Bielak M. Nutrition-Related Knowledge, Diet Quality, Lifestyle, and Body Composition of 7-12-Years-Old Polish Students: Study Protocol of National Educational Project Junior-Edu-Zywienie (JEZ). Nutrients. 2023 Dec 19;16(1):4. doi: 10.3390/nu16010004.
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)
November 1, 2023
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
February 9, 2025
First Submitted That Met QC Criteria
February 17, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 17, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HAPO-02-K-012-2023-10-1787
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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