NCT07124637

Brief 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. The main questions it aims to answer are:

  • 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
205

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 15, 2025

Completed
Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

August 8, 2025

Last Update Submit

August 14, 2025

Conditions

Keywords

FruitVegetableshealthy nutritioneducational interventionSocial Cognitive Theory

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

  • Changes in Cognitive-Social Determinants Related to Fruit and Vegetable Consumption

    Before and two months after the intervention.

Study Arms (2)

Arm 1: Intervention Group

EXPERIMENTAL

Female 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.

Behavioral: Multicomponent Social Cognitive Theory-Based Educational Program to Increase Fruit and Vegetable consumption in Students

Arm 2: Control Group

NO INTERVENTION

Participants 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.

Interventions

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: A) 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 B) 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.

Arm 1: Intervention Group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seydun Public Schools

Ahvāz, Khouzestan, 6133513347, Iran

Location

Study Officials

  • Arash Salahshouri, Ph.D.

    Ahvaz Jundishapur University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty member

Study Record Dates

First Submitted

August 8, 2025

First Posted

August 15, 2025

Study Start

April 25, 2023

Primary Completion

October 23, 2023

Study Completion

May 12, 2024

Last Updated

August 15, 2025

Record last verified: 2025-08

Locations