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| ID | Type | Description | Link |
|---|---|---|---|
| 352614 | Other Grant/Funding Number | Research Council Norway |
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| Name | Class |
|---|---|
| Institute for Implementation Science and Health | OTHER |
| Public Health Foundation of India | OTHER |
| University of Birmingham | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Receive co-created multicomponent school nutrition intervention and usual nutrition program | Experimental |
| |
| Usual nutrition program | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multicomponent school nutrition intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of healthy weight adolescents and body mass index for age | 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 |
| 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 | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abhijit Sen, PhD | Contact | +4773412950 | abhijit.sen@ntnu.no |
| Name | Affiliation | Role |
|---|---|---|
| Archana Shrestha, PhD | Institute for Implementation Science and Health | Principal Investigator |
| Monica Arora, PhD | Public Health Foundation India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Delhi | Delhi | India | ||||
| Budhanilakantha Municipality |
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We will utilise a hybrid type II approach to assess effectiveness and implementation using a parallel arm cluster RCT design with 12 months follow up
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| Usual nutrition program | Other | Usual nutrition program that is being implemented, no any additional active intervention |
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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 | Measured using Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) | At enrollment and at 12 months follow up |
| Budhanilakantha |
| Bagmati |
| Nepal |
| ID | Term |
|---|---|
| D013851 | Thinness |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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