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Promoting on Fruit and Vegetable ConsumptionNCT07124637

Educational Intervention on Promoting Fruit and Vegetable Consumption Among Students

A study testing Multicomponent Social Cognitive Theory-Based Educational Program to Increase Fruit and Vegetable consumption in Students in people with Promoting on Fruit and Vegetable Consumption, run by Ahvaz Jundishapur University of Medical Sciences at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to learn if a multilevel blended educational intervention based on Social Cognitive Theory (SCT) can increase fruit and vegetable (F\&V) consumption among female students. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
What is being tested?
Multicomponent Social Cognitive Theory-Based Educational Program to Increase Fruit and Vegetable consumption in Students
Could I receive a placebo?
No, everyone receives an active treatment
How many people
205 participants
Where
1 siteIran
Study dates
25 Apr 2023to 12 May 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 Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Free of nutrition-related diseases,
  • Not following any special diets or weight loss programs,
  • Provided informed consent to participate,
  • Possess a smartphone compatible with the educational application,
  • Residents of Seydun city,
  • Not currently participating in similar educational programs.

Who cannot join

  • Incomplete or invalid questionnaire responses (e.g., response time less than 7 minutes),
  • Absence from more than one educational session,
  • Voluntary withdrawal from the study.

Trial locations and contacts

1 site in 1 country.

Iran1 site
  • Seydun Public Schools

    Ahvāz, Khouzestan, 6133513347

Other trials in Iran

About this study

Official title: Investigating the Effect of an Educational Intervention Based on Social Cognitive Theory on Promoting Fruit and Vegetable Consumption Among Students

The goal of this clinical trial is to learn if a multilevel blended educational intervention based on Social Cognitive Theory (SCT) can increase fruit and vegetable (F\&V) consumption among female students.

The main questions it aims to answer are:

Read more
  • Does an SCT-based educational program increase the daily amount of fruit and vegetable intake among adolescent girls?
  • Does the intervention improve key cognitive-social constructs such as self-efficacy, self-regulation, knowledge, behavioral skills, and social support related to healthy eating? Researchers will compare students in the intervention group who receive seven 60-minute blended sessions (including face-to-face and WhatsApp-based education) tailored according to SCT constructs to a control group receiving no intervention.

Participants will:

  • Attend scheduled educational sessions covering nutrition knowledge, skill-building (e.g., meal preparation with F\&V), and behavior change strategies.
  • Participate in activities designed to enhance self-efficacy, observational learning, and social support for healthy eating.
  • Complete validated questionnaires assessing F\&V intake and SCT-related cognitive-social constructs before and two months after the intervention.

This study evaluates whether integrating theory-driven, multilevel interventions in schools is effective in promoting healthier dietary habits among adolescent girls, especially in a resource-constrained setting.

Read the detailed description

This cluster-randomized controlled trial was conducted from April 2023 to October 2024 in four public middle schools in Seydun, Khuzestan Province, Iran. The primary aim was to evaluate the effectiveness of a multilevel blended educational intervention based on Social Cognitive Theory (SCT) in increasing fruit and vegetable (F\&V) consumption among female students in grades 7 to 9.

Study Design and Setting:

A two-group parallel design was employed. Four public middle schools in Seydun were randomly assigned by cluster randomization: two schools to the intervention arm and two schools to the control arm. This design minimized contamination and strengthened internal validity. The intervention spanned eight weeks, delivered through a blended format combining in-person sessions and virtual meetings via WhatsApp.

Participants and Sampling:

The target population included all female students in grades 7, 8, and 9 attending the selected schools. Multistage sampling was performed. Initially, schools were randomly chosen, and then from each grade, students were selected by convenience sampling to reach the calculated sample size. Eligibility criteria included absence of nutrition-related diseases (such as diabetes or morbid obesity), no participation in concurrent similar educational programs, smartphone access for virtual components, residency in Seydun city, and provision of informed consent by both students and their parents.

A total of 252 students were initially enrolled (126 in each arm). Following attrition due to withdrawal, incomplete questionnaires, and other reasons, 205 participants completed the study (104 in intervention, 101 in control).

Intervention:

The intervention was designed and implemented based on the Social Cognitive Theory framework, targeting multiple levels of influence on dietary behaviors including individual cognition, social support, and environmental conditions.

Seven 60-minute sessions were delivered over approximately two months. These sessions employed various teaching methods: lectures, group discussions, Q\&A, drawing activities, audiovisual clips, small texts, slides, posters, and pamphlets. Content was tailored using baseline pre-test data and SCT constructs such as self-efficacy, self-regulation, outcome expectations and values, behavioral skills, observational learning, environmental influences, and social support.

In addition to direct education, the program worked collaboratively with parents and school staff. Parent workshops emphasized creating a supportive home environment by encouraging regular provision of fresh fruits and vegetables and reducing availability of unhealthy snacks. School cafeteria staff were engaged to improve accessibility to healthy food options. Student groups promoting healthy eating were also formed to foster peer support and positive norms.

The control group received no educational intervention but completed baseline and follow-up questionnaires at similar time intervals.

Data Collection Instruments:

Data were collected using a comprehensive, researcher-developed questionnaire validated for this population. It comprised:

Demographic and background characteristics (age, BMI, parental education and occupation, household income, etc.) Dietary intake frequency of various fruits and vegetables measured on a 6-point scale (0 = none to 5 = 5 or more servings per day)

  • SCT constructs assessed by multiple scales:
  • Self-efficacy (6 items)
  • Self-regulation (4 items)
  • Observational learning (4 items)
  • Outcome expectations (9 items)
  • Outcome values (7 items)
  • Knowledge (14 items with multiple-choice and true/false questions)
  • Behavioral skills (3 items)
  • Environmental conditions (8 items)
  • Social support (4 items) Responses used Likert scales ranging from 1 (strongly disagree/never) to 5 (strongly agree/always). The questionnaire demonstrated high validity and reliability (Cronbach's alpha = 0.92).

Procedures:

After obtaining ethics committee approval, informed consent was secured. Baseline data collection was conducted before the intervention in both groups. The intervention group participated in the blended educational program while the control group did not receive education.

Follow-up data collection occurred two months post-intervention using the same questionnaire tools. Data quality control included filtering incomplete questionnaires, answer time thresholds to ensure validity, and attrition monitoring.

Statistical Analysis:

Data normality was tested using Kolmogorov-Smirnov tests. Descriptive statistics summarized participant characteristics. Chi-square and Fisher's exact tests compared categorical variables between groups. Independent t-tests assessed intergroup differences in quantitative measures. Paired t-tests evaluated within-group changes. Analysis of covariance (ANCOVA) was performed to adjust for baseline differences when assessing intervention effects on F\&V consumption.

Being tested
Multicomponent Social Cognitive Theory-Based Educational Program to Increase Fruit and Vegetable consumption in Students
Keywords
Fruit, Vegetables, healthy nutrition, educational intervention, Social Cognitive Theory

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multicomponent Social Cognitive Theory-Based Educational Program to Increase Fruit and Vegetable consumption in StudentsBehavioural

    This multilevel blended educational intervention applies Social Cognitive Theory (SCT) to increase fruit/vegetable (F/V) intake among female middle school students. The 8-week program includes:

    1. Student Components:
    • Seven 60-minute sessions (4 in-person, 3 WhatsApp-delivered)
    • Interactive activities: cooking demonstrations, goal-setting workshops, and educational games
    • SCT-focused content: self-efficacy building, outcome expectation modification
    1. Parental Engagement:
    • Weekly SMS nutrition tips
    • Two virtual workshops on creating F/V-supportive home environments
    • School Environment Modifications:
    • Cafeteria redesign to promote F/V accessibility
    • Peer-led 'Healthy Eating Ambassador' program

    Unique aspects distinguishing this intervention:

    • First SCT-based program specifically adapted for Iranian adolescent females
    • Dual delivery (in-person + digital) optimized for school settings
    • Simultaneously targets individual, social, and environmental determinants.
Study groups in NCT07124637
Study groupRoleWhat they receive
Arm 1: Intervention GroupExperimentalFemale students in grades 7-9 received a multilevel educational intervention based on Social Cognitive Theory to increase fruit and vegetable consumption. The program included seven 60-minute sessions that were delivered both face-to-face at schools and virtually via WhatsApp, focusing on enhancing constructs of Social Cognitive Theory. Parents received online training and supportive text messages. School staff cooperated to improve access to fruits and vegetables and displayed educational materials to reinforce behavior change.
Receives: Behavioral: Multicomponent Social Cognitive Theory-Based Educational Program to Increase Fruit and Vegetable consumption in Students
Arm 2: Control GroupNo interventionParticipants in this arm are female students in grades 7 to 9 who do not receive any educational intervention during the study period. They complete the same baseline and follow-up assessments as the intervention group but continue their usual activities without additional programs related to diet or nutrition. Intervention Details: No intervention provided Participate in data collection before and two months after the intervention period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Daily Fruit and Vegetable (F&V) Consumption

    Daily fruit and vegetable consumption among female students in grades 7 to 9 was assessed using a validated dietary questionnaire. This researcher-developed instrument included 27 items across two sections-12 items for fruit and 15 items for vegetable intake-measured on a 6-point scale ranging from 0 ("Did not consume") to 5 ("5 servings per day"). Consumption was expressed as the average number of daily servings, with scores ranging from 0 to 5. Higher scores indicate greater F\&V intake, reflecting healthier dietary behavior.

    Measured: Baseline (pre-intervention) and 2 months post-intervention.

Secondary outcomes (1)
  1. Changes in Cognitive-Social Determinants Related to Fruit and Vegetable Consumption

    This outcome assesses changes in Social Cognitive Theory (SCT)-based determinants of fruit and vegetable intake, including self-efficacy (6 items; Self-Efficacy Scale for fruit and vegetable consumption, score range: 6-30), self-regulation (4 items; score range: 4-20), observational learning (4 items; score range: 4-20), outcome expectations (9 items; score range: 9-45), outcome values (7 items; score range: 7-35), knowledge (14 items; score range: 0-14), and behavioral skills (3 items; score range: 3-15). On all scales, higher scores indicate more favorable outcomes, such as greater self-efficacy or higher knowledge levels. These constructs were measured using validated questionnaires at baseline and two months after the intervention.

    Measured: Before and two months after the intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2025
  2. Study start25 Apr 2023
  3. Primary completion23 Oct 2023
  4. Study completion12 May 2024

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study uses a parallel-group design, where participants are assigned to one of two groups: an intervention group or a control group. Each group was followed concurrently throughout the study period. The intervention group receives a multilevel blended educational program based on Social Cognitive Theory, while the control group does not receive this program. Outcomes related to fruit and vegetable consumption and cognitive-social constructs were measured and compared between groups at baseline and two months after the intervention. This design allows for direct comparison of the intervention's effectiveness against usual conditions without intervention.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07124637
Sponsor's protocol ID
IR.AJUMS.REC.1402.106
Status last verified
Aug 2025
First submitted
8 Aug 2025
Last updated
15 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Public release of these data is not part of the research plan. However, upon reasonable request from researchers, and with ethics committee approval and strict confidentiality maintained, participant data can be shared with researchers in a controlled and limited manner.

Questions about this trial

What is this clinical trial studying?

A study testing Multicomponent Social Cognitive Theory-Based Educational Program to Increase Fruit and Vegetable consumption in Students in people with Promoting on Fruit and Vegetable Consumption, run by Ahvaz Jundishapur University of Medical Sciences at 1 site in Iran.

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 6 inclusion and 3 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 15 Aug 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 Iran. 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?

Change in Daily Fruit and Vegetable (F&V) Consumption (time frame: Baseline (pre-intervention) and 2 months post-intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 15 Aug 2025; AzTrials last refreshed its copy on 27 Oct 2026.

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