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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:
Participants will:
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.
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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multicomponent Social Cognitive Theory-Based Educational Program to Increase Fruit and Vegetable consumption in Students | Behavioral | 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:
B) Parental Engagement:
Unique aspects distinguishing this intervention:
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arash Salahshouri, Ph.D. | Ahvaz Jundishapur University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seydun Public Schools | Ahvāz | Khouzestan | 6133513347 | Iran |
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.
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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.
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| Before and two months after the intervention. |