NCT06836336

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

February 9, 2025

Last Update Submit

February 17, 2025

Conditions

Keywords

DietAnxietyNutritional knowledgeEducational interventionSaudi ArabiaAdolescentsDigitalHybrid intervention

Outcome Measures

Primary Outcomes (1)

  • 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).

    From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (3)

  • Generalized Anxiety Disorder Scores (GAD)

    From enrollment to the end of treatment at 4 weeks

  • Dietary habits

    From enrollment to the end of treatment at 4 weeks

  • Anthropometric measurements (Body mass index)

    From enrollment to the end of treatment at 4 weeks

Study Arms (2)

Hybrid intervention

EXPERIMENTAL

Hybrid intervention that combined face-to-face educational sessions with the integration of technological advancements.

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.

Behavioral: Fully digital

Interventions

Hybrid therapyBEHAVIORAL

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.

Hybrid intervention
Fully digitalBEHAVIORAL

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.

Fully digital intervention

Eligibility Criteria

Age15 Years - 19 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy
  • Adolescents (15-19 years old)
  • Reliable internet access
  • Willing to participate

You may not qualify if:

  • Has chronic disease/s
  • \<15 years and \>19 years
  • No internet access
  • Not willing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Fatat Private School

Mecca, Saudi Arabia

Location

Related Publications (8)

  • 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.

    PMID: 30979065BACKGROUND
  • 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.

    PMID: 32823548BACKGROUND
  • 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.

    PMID: 37337137BACKGROUND
  • 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.

    PMID: 34087087BACKGROUND
  • 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.

    PMID: 39808604BACKGROUND
  • 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.

    PMID: 28436102BACKGROUND
  • 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.

    PMID: 34856192BACKGROUND
  • 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.

    PMID: 38201834BACKGROUND

MeSH Terms

Conditions

Generalized Anxiety DisorderFeeding BehaviorAnxiety Disorders

Interventions

Hybrid Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Mental DisordersBehavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Mai A Ghabashi, PhD

    Umm Al-Qura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 9, 2025

First Posted

February 20, 2025

Study Start

November 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

February 20, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations