Nutrition KnowledgeNCT06836336
Digital Versus Hybrid Interventions in Promoting Nutrition Knowledge Among Saudi Adolescent Girls
A study testing Hybrid therapy and Fully digital in people with Nutrition Knowledge and Generalized Anxiety Disorder (GAD), run by Umm Al-Qura University at 1 site in Saudi Arabia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nutrition Knowledge, Generalized Anxiety Disorder (GAD), Food Habits
- What is being tested?
- Hybrid therapy and Fully digital
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Nov 2023to 31 Dec 2024
- 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 15 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy
- Adolescents (15-19 years old)
- Reliable internet access
- Willing to participate
Who cannot join
- Has chronic disease/s
- <15 years and >19 years
- No internet access
- Not willing to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Hybrid therapy, Fully digital
- Keywords
- Diet, Anxiety, Nutritional knowledge, Educational intervention, Saudi Arabia, Adolescents, Digital, Hybrid intervention
- Medical subject headings
- Generalized Anxiety Disorder, Feeding Behavior, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid therapyBehavioural
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.
Fully digitalBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid intervention | Experimental | Hybrid intervention that combined face-to-face educational sessions with the integration of technological advancements. Receives: Behavioral: Hybrid therapy |
| Fully digital intervention | Experimental | Received the same educational materials as the hybrid intervention group through WhatsApp twice a week over the course of one month. Receives: Behavioral: Fully digital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutrition knowledge
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).
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (3)
Generalized Anxiety Disorder Scores (GAD)
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).
Measured: From enrollment to the end of treatment at 4 weeks
Dietary habits
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.
Measured: From enrollment to the end of treatment at 4 weeks
Anthropometric measurements (Body mass index)
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.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Nov 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Nutrition KnowledgeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants were randomly assigned to one of two groups. First group received a 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. This content was developed by a professional team, including registered dietitians and physicians. Second group received a fully digital intervention, 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. The digital intervention incorporated the same behavior change strategies that were utilized in the hybrid group. Participants were introduced to MyFittnessPal
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Essra Noorwali, Umm Al-Qura University
- Investigators
- Mai A Ghabashi, PhD, Principal investigator, Umm Al-Qura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836336
- Sponsor's protocol ID
- HAPO-02-K-012-2023-10-1787
- Status last verified
- Feb 2025
- First submitted
- 9 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30979065Charles 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.
PubMed 32823548Bany-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.
PubMed 37337137Saha 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.
PubMed 34087087Lwin 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.
PubMed 39808604Das 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.
PubMed 28436102Hargreaves 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.
PubMed 34856192Hamulka 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.
PubMed 38201834
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Digital Versus Hybrid Interventions in Promoting Nutrition Knowledge Among Adolescent Girls: A Randomized Trial
- ClinicalTrials.gov ID
- NCT06836336
- Acronym / sponsor ID
- HAPO-02-K-012-2023-10-1787
- Keywords
- Diet, Anxiety, Nutritional knowledge, Educational intervention, Saudi Arabia, Adolescents, Digital, Hybrid intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 20 Feb 2025 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants were randomly assigned to one of two groups. First group received a 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. This content was developed by a professional team, including registered dietitians and physicians. Second group received a fully digital intervention, 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. The digital intervention incorporated the same behavior change strategies that were utilized in the hybrid group. Participants were introduced to MyFittnessPal
| Arm | Type | Receives |
|---|---|---|
| Hybrid intervention | Experimental | Behavioral: Hybrid therapyHybrid intervention that combined face-to-face educational sessions with the integration of technological advancements. |
| Fully digital intervention | Experimental | Behavioral: Fully digitalReceived the same educational materials as the hybrid intervention group through WhatsApp twice a week over the course of one month. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Healthy
- Adolescents (15-19 years old)
- Reliable internet access
- Willing to participate
Key exclusion criteria (4 listed)
- Has chronic disease/s
- <15 years and >19 years
- No internet access
- Not willing to participate
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 |
|---|---|---|
| Hybrid therapyHybrid 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. | Behavioural | Hybrid intervention |
| Fully digitalFully 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. | Behavioural | Fully digital intervention |
Primary outcome
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).
3 secondary outcomes
Generalized Anxiety Disorder Scores (GAD)
Time frame: From enrollment to the end of treatment at 4 weeks
Dietary habits
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Background: PubMed 30979065Ashton 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.
- Background: PubMed 32823548Charles 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.
- Background: PubMed 37337137Bany-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.
- Background: PubMed 34087087Saha 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.
- Background: PubMed 39808604Lwin 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.
- Background: PubMed 28436102Das 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.
- Background: PubMed 34856192Hargreaves 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.
- Background: PubMed 38201834Hamulka 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.
- Individual participant dataSharing planned: No
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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.
Mai A Ghabashi, PhD principal investigator
Umm Al-Qura 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 Hybrid therapy and Fully digital in people with Nutrition Knowledge and Generalized Anxiety Disorder (GAD), run by Umm Al-Qura 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 20 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutrition knowledge (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06836336, which also lists 8 linked publications.
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 20 Feb 2025.