Building Healthy Food Environment in Schools: Evaluating Co-created Interventions in Low Resource Settings. #BetterNutrition4Adolescent
The goal of this clinical trial is to learn if a multicomponent nutrition program developed together with the students, parents, teachers and canteen operators will improve nutrition status of adolescents. It will also learn about the acceptability and feasibility of implementing the program in the school settings. The main questions it aims to answer are:
What is the effect of co-created multicomponent intervention promoting healthy food behavior and environment in schools on the proportion of normal weight adolescents? What proportion of the target adolescents and teachers does the intervention reach? What proportion of the schools are willing to implement the intervention? What was the level of fidelity of implementation of all components of the intervention and the barriers and facilitators to implementation? What is the cost for maintenance, and facilitators and barriers of sustainment? School going adolescents studying in grades 7 to 9 from 26 schools in India and 26 schools in Nepal will be enrolled in the trial and their height, weight, dietary behavior, mental well-being and physical activity will be measured at baseline and at 12 months follow up. After the baseline assessment the school community (students, school environment, parents, teachers, canteen operators) will receive the intervention.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Abhijit Sen, PhD
- Phone Number: +4773412950
- Email: abhijit.sen@ntnu.no
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adolescents studying in grade 7 to 9 (aged 11-15 years) Exclusion criteria:
Exclusion Criteria:
- 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 follow up period) will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Receive co-created multicomponent school nutrition intervention and usual nutrition program
|
The intervention will include innovative components that aims to change school food environment, nutrition education to promote healthy eating and community and parental involvement.
This section will be completed after the intervention package is finalized during the co-creation phase.
|
|
Active Comparator: Usual nutrition program
|
Usual nutrition program that is being implemented, no any additional active intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of healthy weight adolescents and body mass index for age
Time Frame: At enrollment and at 12 months follow up
|
Height and weight of the adolescents will be measured to calculate body mass index using age and sex specific charts and categorize them as Underweight: Less than the 5th percentile, Healthy weight: 5th percentile up to the 85th percentile , Overweight: 85th percentile to less than the 95th percentile, Obesity: 95th percentile or higher
|
At enrollment and at 12 months follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total intake of fruits and vegetables, dairy products, meat and beans (protein), whole grains, sugar-sweetened beverages, fast food, and salty snacks
Time Frame: At enrollment and at 12 months follow up
|
A 24 hour dietary recall will be taken (two times during week days and weekends)
|
At enrollment and at 12 months follow up
|
|
Total metabolic equivalent per day (MET per day)
Time Frame: At enrollment and at 12 months follow up
|
Use International Physical activity questionnaire for adolescent to measure specific types, frequency and duration across different domains.
|
At enrollment and at 12 months follow up
|
|
Mental wellbeing
Time Frame: At enrollment and at 12 months follow up
|
Measured using Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
|
At enrollment and at 12 months follow up
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Archana Shrestha, PhD, Institute for Implementation Science and Health
- Principal Investigator: Monica Arora, PhD, Public Health Foundation India
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 352614 (Other Grant/Funding Number: Research Council Norway)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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