Clinical trial NCT06996847: A Protocol to Promote Critical Consumption (PCC)
Official title: Effectiveness of a Psychoeducational Program to Promote a Critical Attitude Towards the Symbolic Consumption of Yoghurt in Primary School Children: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Promote a Critical Attitude Towards the Symbolic Consumption of Youghurt in Primary School Children
Keywords: Child Behavior
Intervention / Treatment
Mental Health/education
Psychosocial Functioning
Feeding Behavior
Lead sponsor: Universidad de San Martín de Porres
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 500
Sex: ALL
Minimum age (years): 9
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this randomised controlled trial is to evaluate the efficacy of an intervention called a psychoeducational programme to promote a critical attitude towards the symbolic consumption of yoghurt in primary school children. Specifically, a cluster randomised controlled trial will be conducted in primary schools in Lima, Peru. After informed consent of the tutor psychologists, children and parents, schools will be randomly assigned, in a 1:1 ratio, to the intervention or control group, with a total of 240 fourth grade students and 24 tutor psychologists. The primary and secondary research questions are as follows.

Detailed description: The aim of this randomised controlled trial is to evaluate the efficacy of an intervention called a psychoeducational programme to promote a critical attitude towards the symbolic consumption of yoghurt in primary school children.

Specifically, a cluster randomised controlled trial will be conducted in primary schools in Lima, Peru. After informed consent of the tutor psychologists, children and parents, schools will be randomly assigned, in a 1:1 ratio, to the intervention or control group, with a total of 240 fourth grade students and 24 tutor psychologists. The primary and secondary research questions are as follows.

The primary research question:

• Is the intervention effective in fostering critical attitudes towards symbolic yoghurt consumption in children from pre-test to post-test (Record of symbolic consumption responses: self, parent and facilitator reports)?

The secondary research questions:

* Is the intervention effective in stabilising the child's deductive skills?
* Is the main question moderated by the child's gender, physical disability, dysfunctional state and the facilitator's experience? The intervention will take place in the school classroom (2 sessions of 1 hour per week) for 3 consecutive weeks, plus a feedback session (1 hour per week); and a further session with parents (1 hour per week). A set of participatory techniques will be included to help distinguish between symbolic and nutritional aspects of yoghurt (e.g. role play), to help understand the persuasive intent of advertising (e.g. opinion wheel), and to help balance between peer pressure consumption and critical attitude. The control group will carry out the usual teaching and will receive the set of activities after the end of the trial. After two interviews with the child and another interview with the parents, the Symbolic Consumption Response Register will be completed, and the Raven's Progressive Matrices Test-2 will be applied before and immediately after the intervention, both in the control group and in the intervention group. The facilitators of both groups will complete a form immediately after the end of each psychoeducational activity for both children and parents Eligibility Criteria Description Additional inclusion criteria for schools are: (a) access to the classroom within the school, and (b) written informed consent for participation in this study by the 4th grade primary school psychologists. Inclusion criteria for children are: (a) enrolled in 4th grade, (b) give informed consent, (c) have written informed consent from their parents or legal guardians, present normal intelligence according to the Raven's Progressive Matrices Test-2.

Eligibility criteria: Inclusion Criteria:

For children:

* Enrolled in 4th grade
* Provide informed assent
* Have written informed consent from their parents or legal guardians
* Present normal intelligence according to the Raven's Progressive Matrices Test-2

For schools:

* Provide access to the classroom within the school
* Provide written informed consent for participation from 4th grade primary school psychologists

Exclusion Criteria:

* Not enrolled in 4th grade
* Suffering from a mental disorder
* Repeating 4th grade
* Below normal intelligence according to the Raven-2 Progressive Matrices Test

Primary outcomes:
measure: Change from the child's initial symbolic consumption at 6 weeks
timeFrame: Baseline, 6 weeks
measure: Change from the child's initial symbolic consumption at 19 weeks
timeFrame: Baseline, 19 weeks
Secondary outcomes:
measure: Stability of child's deductive ability at 6 weeks
timeFrame: Baseline, 6 weeks
measure: Stability of child's deductive ability at 19 weeks
timeFrame: Baseline, 19 weeks
measure: Children's assessment of the psychoeducational programme
timeFrame: 6 weeks
measure: Child's Sex
timeFrame: Baseline
measure: Assessment of facilitators' performance
timeFrame: Baseline
measure: Children's psychosocial or behavioral dysfunction
timeFrame: Baseline
Other outcomes:
measure: Adherence Assessments: Facilitator's registration
timeFrame: Weekly during the intervention phase (6 weeks) in the intervention group
Locations:
Study officials:
affiliation: Research Institute, FCCTP, San Martin de Porres University, Peru
name: Luis Fidel Abregú Tueros, PhD
role: PRINCIPAL_INVESTIGATOR
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