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临床试验/CTRI/2025/09/095400
CTRI/2025/09/095400尚未招募不适用

Building Healthy Food Environment in Schools: Evaluating Co-created Interventions in Low Resource Settings.

Public Health Foundation of India (PHFI)1 个研究点 分布在 1 个国家目标入组 2,600 人开始时间: 2026年10月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
2,600
试验地点
1
主要终点
The primary outcome is the difference in the proportion of normal weight adolescents in the intervention and control at 12 months follow up. We hypothesize promoting healthy food behaviour and environment in school would increase the proportion of normal weight by decreasing the proportion of overweight, obese, and underweight adolescents.

研究概览

简要总结

Project Summary:

The study aims to co-create, implement, and robustly evaluate an innovative multicomponent intervention (MI) that addresses adolescents’ current and future health**.**

The specific objectives are:

Objective 1: Community-engaged co-creation of a contextual MI to promote healthy food behaviour and environment in schools.

Objective 2: Implement and evaluate the MI in schools in India and assess effectiveness on the proportion of normal-weight adolescents as primary outcome and secondary outcomes such as global dietary recommendation score (GDRS), physical activity, and mental well-being score.

Objective 3: Evaluate the implementation of MI using the RE-AIM framework, assessing reach, adoption, implementation, and maintenance.

Objective 4: Conduct a cost-effectiveness analysis to change BMI (from overweight/obese/underweight to normal weight) and improve GDRS.

Research questions and hypotheses, theoretical approach, and methodology

The overarching research question guiding this project is: How can adolescents be supported and encouraged to adopt healthy food behaviour through co-created MI in school? Based on the state of the art, professional experience, and previous pilot project findings, our hypotheses are:

**1.**Adequate understanding of the context (stakeholders, resources, facilitators, and barriers) is needed to effectively engage communities in co-creation. (Work package (WP) 1)

**2.**MI package co-created with stakeholders will be acceptable to the end-users and foster ownership and adaptation. (WP2 and 4)

3.       Healthy food behaviour and environment in schools can reduce overweight and underweight and promote physical and mental health. (WP3)

**4.**Providing school-wide intervention will reinforce behaviours through peer support. (WP3)

**5.**Improvements in adolescent BMI occurs through multiple pathways (knowledge and supportive school environment). (WP3)

6.       Understanding of the mechanisms behind the interventions’ effects will guide future scale up. (WP4)

7.       It will be cost-effective to implement a co-created MI package in schools. (WP5)

This study will collect qualitative and quantitative data through various methods, categorized under different Work Packages (WPs):

Work Package 1 (WP1): In-depth Interviews (IDIs): Conducted with principals, teachers, school administrators, canteen staff, food vendors, and parents of 7-10 grade students. Focus Group Discussions (FGDs): Conducted with students

Work Package 3 (WP3): Anthropometric Measurements: Height and weight will be measured at baseline and follow-up to calculate BMI. The primary outcome is the difference in the proportion of normal-weight adolescents between the intervention and control groups at 12 months.

Dietary Intake & Quality: Measured using a diet quality questionnaire adapted for India (29 questions). Physical Activity Levels: Assessed using the Global Physical Activity Questionnaire (GPAQ). Mental Well-being.

Demographic & Socioeconomic Data: Includes age, gender, education, and environmental factors, collected at baseline and follow-up.

Work Package 4 (WP4):  Survey on Willingness for Healthy Dietary Choices: Adolescents will rate their likelihood of choosing specific healthy food options for lunch or snacks on a Likert scale (1–5). Focus Group Discussions (FGDs): Six FGDs will be conducted with teachers (n=3) and adolescents (n=3). Key Informant Interviews (KIIs): A total of n=16 will be conducted with key stakeholders, including public health and education officers, school principals, canteen staff, and food vendors, to assess facilitators and barriers to implementation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
11.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • Adolescents studying in grades 7 to 9 (aged 11-14 years) will be recruited from private and public schools.

排除标准

  • Adolescents with siblings enrolled in schools assigned to a different trial arm to avoid clustering, with underlying medical conditions, and those who plan to change school within one year of enrollment (during the follow-up period) will be excluded.

结局指标

主要结局

The primary outcome is the difference in the proportion of normal weight adolescents in the intervention and control at 12 months follow up. We hypothesize promoting healthy food behaviour and environment in school would increase the proportion of normal weight by decreasing the proportion of overweight, obese, and underweight adolescents.

时间窗: 12 months follow-up followed by baseline

次要结局

  • Secondary outcomes will be measured by the diet quality questionnaire adopted for India which consists of 29 questions, physical activity measured by the global physical activity questionnaire, and mental wellbeing.(12-month follow-up)

研究者

发起方
Public Health Foundation of India (PHFI)
申办方类型
Other [ngo]
责任方
Principal Investigator
主要研究者

Prof Monika Arora

Public Health Foundation of India (PHFI)

研究点 (1)

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