NCT06996847

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.

Trial Health

65
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Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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 Progress29%
Mar 2026Oct 2026

First Submitted

Initial submission to the registry

May 14, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 30, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2026

Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

May 14, 2025

Last Update Submit

May 26, 2025

Conditions

Keywords

Child BehaviorIntervention / TreatmentMental Health/educationPsychosocial FunctioningFeeding Behavior

Outcome Measures

Primary Outcomes (2)

  • Change from the child's initial symbolic consumption at 6 weeks

    The Symbolic Consumption Response Register (CRR) consists of 15 questions that are used to assess children's attitudes related to symbolic consumption. The frequency of children's symbolic consumption responses during the past week is rated on a 17-point scale (lowest frequency of symbolism = 1-4; intermediate frequency of symbolism = 5-13; highest frequency of symbolism = 14-17). Responses will be examined as an overall result and separately on understanding the persuasive intent of yoghurt advertising, on awareness of peer pressure and on critical attitude to consumption. Information for recording responses will be obtained from two interviews with the child and one interview with the parents, and from the six psychoeducational strategies developed with the children and one session with the parents. The answers of the children and their parents will be reported orally. The responses will be analysed separately.

    Baseline, 6 weeks

  • Change from the child's initial symbolic consumption at 19 weeks

    The Symbolic Consumption Response Register (CRR) consists of 15 questions that are used to assess children's attitudes related to symbolic consumption. The frequency of children's symbolic consumption responses during the past week is rated on a 17-point scale (lowest frequency of symbolism = 1-4; intermediate frequency of symbolism = 5-13; highest frequency of symbolism = 14-17). Responses will be examined as an overall result and separately on understanding the persuasive intent of yoghurt advertising, on awareness of peer pressure and on critical attitude to consumption. Information for recording responses will be obtained from two interviews with the child and one interview with the parents, and from the six psychoeducational strategies developed with the children and one session with the parents. The answers of the children and their parents will be reported orally. The responses will be analysed separately.

    Baseline, 19 weeks

Secondary Outcomes (6)

  • Stability of child's deductive ability at 6 weeks

    Baseline, 6 weeks

  • Stability of child's deductive ability at 19 weeks

    Baseline, 19 weeks

  • Children's assessment of the psychoeducational programme

    6 weeks

  • Child's Sex

    Baseline

  • Assessment of facilitators' performance

    Baseline

  • +1 more secondary outcomes

Other Outcomes (1)

  • Adherence Assessments: Facilitator's registration

    Weekly during the intervention phase (6 weeks) in the intervention group

Study Arms (3)

Intervention group

EXPERIMENTAL

The promotion of critical consumption in children is to be developed in primary school classrooms. Students will spend a total of 7 hours: (2 sessions of 1 hour per week) for 3 consecutive weeks, plus a feedback session (1 hour per week); and there will be another session with parents (1 hour per week). The psychologist tutor will receive a set of six activities related to discriminating between symbolic and critical yoghurt consumption in children, understanding the persuasive intent of yoghurt advertising, awareness of social pressure and critical attitude. Psychological tutors will be trained and provided with support materials and equipment.

Behavioral: psychoeducational programme to promote a critical attitude towards the symbolic consumption of yoghurt in primary school children

Protocol to encourage critical consumption

OTHER

As detailed in the description for the intervention group, the psychologist tutors guide the students in the classroom for two hours per week for three weeks in a row, plus a feedback session. There will also be a session with parents.

Behavioral: psychoeducational programme to promote a critical attitude towards the symbolic consumption of yoghurt in primary school children

No Intervention: Control

NO INTERVENTION

Five months after the start of the randomised clinical trial, primary school teachers in the control group will receive an unguided version of the psychoeducational intervention programme, supplemented by an online peer support group. They will be provided with the six activities related to critical consumption and awareness of the persuasive intent of advertising and social pressure for students to practice independently, in addition to online support from the research group. As in the intervention group, psychological support will be provided to children with emotional difficulties.

Interventions

The promotion of critical consumption in children is to be developed in primary school classrooms. Students will spend a total of 7 hours: (2 sessions of 1 hour per week) for 3 consecutive weeks, plus a feedback session (1 hour per week); and there will be another session with parents (1 hour per week). The psychologist tutor will receive a set of six activities related to discriminating between symbolic and critical yoghurt consumption in children, understanding the persuasive intent of yoghurt advertising, awareness of social pressure and critical attitude. Psychological tutors will be trained and provided with support materials and equipment

Intervention groupProtocol to encourage critical consumption

Eligibility Criteria

Age9 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Money R, Wilde S, Dawson D. Review: The effectiveness of Theraplay for children under 12 - a systematic literature review. Child Adolesc Ment Health. 2021 Sep;26(3):238-251. doi: 10.1111/camh.12416. Epub 2020 Aug 6.

    PMID: 32767491BACKGROUND
  • Lebiger-Vogel J, Rickmeyer C, Leuzinger-Bohleber M, Meurs P. Fostering Emotional Availability in Mother-Child-Dyads With an Immigrant Background: A Randomized-Controlled-Trial on the Effects of the Early Prevention Program First Steps. Front Psychol. 2022 Apr 7;13:790244. doi: 10.3389/fpsyg.2022.790244. eCollection 2022.

    PMID: 35465509BACKGROUND
  • Vanderbilt KE, Andreason C. The influence of popular media characters on children's object choices. Br J Dev Psychol. 2023 Mar;41(1):1-12. doi: 10.1111/bjdp.12434. Epub 2022 Oct 12.

    PMID: 36224492BACKGROUND
  • Triece P, Massazza A, Fuhr DC. Effectiveness and implementation outcomes for peer-delivered mental health interventions in low- and middle-income countries: a mixed-methods systematic review. Soc Psychiatry Psychiatr Epidemiol. 2022 Sep;57(9):1731-1747. doi: 10.1007/s00127-022-02294-y. Epub 2022 Apr 29.

    PMID: 35484436BACKGROUND

Related Links

MeSH Terms

Conditions

Child BehaviorPsychological Well-BeingFeeding Behavior

Condition Hierarchy (Ancestors)

BehaviorPersonal SatisfactionBehavior, Animal

Study Officials

  • Luis Fidel Abregú Tueros, PhD

    Research Institute, FCCTP, San Martin de Porres University, Peru

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Fidel Abregú Tueros, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2025

First Posted

May 30, 2025

Study Start

March 1, 2026

Primary Completion (Estimated)

June 14, 2026

Study Completion (Estimated)

October 25, 2026

Last Updated

May 30, 2025

Record last verified: 2025-05