Overweight AdolescentsNCT07332676
Building Healthy Food Environment in Schools: Evaluating Co-created Interventions in Low Resource Settings. #BetterNutrition4Adolescent
A study testing Multicomponent school nutrition intervention and Usual nutrition program in people with Overweight Adolescents and Underweight, run by Norwegian University of Science and Technology at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 11 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight Adolescents, Underweight, Obese Adolescents
- What is being tested?
- Multicomponent school nutrition intervention and Usual nutrition program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,600 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescents studying in grade 7 to 9 (aged 11-15 years) Exclusion criteria:
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
About this study
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.
- Conditions
- Overweight Adolescents, Underweight, Obese Adolescents
- Being tested
- Multicomponent school nutrition intervention, Usual nutrition program
- Keywords
- nutrition, multicomponent nutrition intervention, co-creation, adolescent, low resource settings, Poor nutrition
- Medical subject headings
- Thinness, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent school nutrition interventionOther
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.
Usual nutrition programOther
Usual nutrition program that is being implemented, no any additional active intervention
| Study group | Role | What they receive |
|---|---|---|
| Receive co-created multicomponent school nutrition intervention and usual nutrition program | Experimental | Not described Receives: Other: Multicomponent school nutrition intervention |
| Usual nutrition program | Active comparator | Not described Receives: Other: Usual nutrition program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At enrollment and at 12 months follow up
Secondary outcomes (3)
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)
Measured: At enrollment and at 12 months follow up
Total metabolic equivalent per day (MET per day)
Use International Physical activity questionnaire for adolescent to measure specific types, frequency and duration across different domains.
Measured: At enrollment and at 12 months follow up
Mental wellbeing
Measured using Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
Measured: At enrollment and at 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight AdolescentsStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 2,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Implementation Science and Health, Public Health Foundation of India, University of Birmingham
- Responsible party
- Sponsor
- Investigators
- Archana Shrestha, PhD, Principal investigator, Institute for Implementation Science and HealthMonica Arora, PhD, Principal investigator, Public Health Foundation India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332676
- Sponsor's protocol ID
- 352614
- Other IDs
- 352614
- Status last verified
- Dec 2025
- First submitted
- 30 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Healthy Food Environment in Schools: Evaluating Co-created Interventions in Low Resource Settings. #BetterNutrition4Adolescent
- ClinicalTrials.gov ID
- NCT07332676
- Acronym / sponsor ID
- 352614
- Conditions
- Overweight Adolescents, Underweight, Obese Adolescents
- Keywords
- nutrition, multicomponent nutrition intervention, co-creation, adolescent, low resource settings, Poor nutrition
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,600 participants (estimated)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Institute for Implementation Science and Health, Public Health Foundation of India, University of Birmingham
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Receive co-created multicomponent school nutrition intervention and usual nutrition program | Experimental | Other: Multicomponent school nutrition intervention |
| Usual nutrition program | Active comparator | Other: Usual nutrition program |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Adolescents studying in grade 7 to 9 (aged 11-15 years) Exclusion criteria:
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent school nutrition interventionThe 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. | Other | Receive co-created multicomponent school nutrition intervention and usual nutrition program |
| Usual nutrition programUsual nutrition program that is being implemented, no any additional active intervention | Other | Usual nutrition program |
Primary outcome
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
3 secondary outcomes
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
Total metabolic equivalent per day (MET per day)
Time frame: At enrollment and at 12 months follow up
Mental wellbeing
Time frame: At enrollment and at 12 months follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Archana Shrestha, PhD principal investigator
Institute for Implementation Science and Health
Monica Arora, PhD principal investigator
Public Health Foundation India
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent school nutrition intervention and Usual nutrition program in people with Overweight Adolescents and Underweight, run by Norwegian University of Science and Technology at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India, Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abhijit Sen, PhD (+4773412950, abhijit.sen@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of healthy weight adolescents and body mass index for age (time frame: At enrollment and at 12 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.