Childhood ObesityNCT05648045
Weight Status, Resilience, and Quality of Life in Indian Children
An observational study of Childhood Obesity and Overweight (BMI > 25), run by Maastricht University Medical Center at 16 sites in India.
Trial summary
A school-based cross-sectional study that aims to generate context-specific evidence on how weight status is related to resilience, health behaviour, and quality of life among Indian adolescents. Read more about this study
- Who is it for?
- Ages 14 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Overweight (BMI > 25), Underweight
- How many people
- 720 participants
- Where
- 16 sitesIndia
- Study dates
- 20 Feb 2023to 30 Apr 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 14 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: School-going Indian adolescents aged 14 to 16 years, studying in grades 8 to 10 in secondary schools in Kolkata, India. Participants were recruited from public and private schools. One parent or guardian of each participating adolescent was also invited to participate. Weight status categories (underweight, normal weight, and overweight/obese) were defined analytically using BMI-for-age z-scores based on IOTF cut-offs.
Who may be able to join
- Adolescents aged 14 to 16 years
- Studying in grades 8, 9, or 10
- Enrolled in participating secondary schools in Kolkata, India
- Able to provide assent, with written consent from a parent or legal guardian
- One parent or guardian willing to participate in the parent survey
Who cannot join
- Age below 14 years or above 16 years
- Not enrolled in grades 8, 9, or 10
- No parental/legal guardian consent or no adolescent assent
- Incomplete eligibility for participation in the survey procedures
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
India16 sites
Mitra Institution (Main)
Kolkata, West Bengal, 700009
Victoria Institution High School
Kolkata, West Bengal, 700009
Ballygunge Government High School
Kolkata, West Bengal, 700020
Andhra Association High School (AAHS)
Kolkata, West Bengal, 700026
Lycee School
Kolkata, West Bengal, 700029
National High School For Boys
Kolkata, West Bengal, 700029
National High School For Girls
Kolkata, West Bengal, 700029
Tollygunge Adarsh Hindi High School (Girls and Boys)
Kolkata, West Bengal, 700033
New Alipore Multipurpose School
Kolkata, West Bengal, 700053
New Vista Academy
Kolkata, West Bengal, 700063
Sakhawat Memorial Govt. Girls' High School
Kolkata, West Bengal, 700071
Calcutta Public School, Bidhan Park
Kolkata, West Bengal, 700090
Indus Valley World School
Kolkata, West Bengal, 700094
Calcutta Public School, Kalikapur
Kolkata, West Bengal, 700099
Holy Mission school
Kolkata, West Bengal
St. Joseph and Mary's school
Kolkata, West Bengal
About this study
Official title: Associations Between Factors Contributing to Obesity (Dietary Behaviour and Physical Activity), Resilience (Dietary and Physical Activity Self-Efficacy, Self- Esteem, General Resilience and Optimism), and HRQoL in Indian Adolescents
A school-based cross-sectional study that aims to generate context-specific evidence on how weight status is related to resilience, health behaviour, and quality of life among Indian adolescents.
Primary Objective
Read more
To assess differences in overall resilience (total score of Adolescent Resilience score from ARQ49) between normal-weight and overweight/obese Indian adolescents aged 14-16 years.
Secondary Objectives
- To compare differences in Adolescent Resilience Questionnaire (ARQ49) subscale scores between normal-weight and overweight/obese adolescents. The internal resilience factors assessed by the ARQ49 include confidence, emotional insight, negative cognition, social skills, empathy, and tolerance, while the external resilience factors include family connectedness, family availability, peer connectedness, peer availability, supportive school environment, school connectedness, and community connectedness.
- To assess differences in internal resilience factors (diet self-efficacy, physical activity self-efficacy, self-esteem, and optimism) between normal-weight and overweight/obese adolescents and to examine parental nutrition knowledge as an external resilience resource and moderator in association analyses.
- To compare dietary behaviors, physical activity patterns, and Pediatric Quality of Life Inventory (PedsQL) scores between normal-weight and overweight/obese adolescents.
- To examine the associations among resilience, dietary and physical activity behaviors, and PedsQL within the overall sample and within different weight groups, and to evaluate parental nutrition knowledge as a moderator of the relationship between weight status and resilience or health outcomes. Exploratory Objective
- To explore differences in resilience, health behaviors, and PedsQL between normal-weight and underweight Indian adolescents.
Study hypotheses
The investigators hypothesized that adolescents with overweight/obesity, compared with their normal-weight peers, would demonstrate lower scores on total resilience (primary outcome), as well as on internal and external resilience indices; report lower diet self-efficacy, physical activity self-efficacy, self-esteem, and optimism; report less frequent health-promoting behaviors (including lower fruit and vegetable intake and fewer days achieving ≥ 60 min/day of moderate-to-vigorous physical activity); and report lower PedsQL scores.
Parental nutrition knowledge will not be treated as a between-group outcome; instead, it will be tested as a moderator in association analyses, examining whether parental nutrition knowledge influences the relationship between weight status and resilience or health outcomes.
Furthermore, the investigators hypothesized that higher resilience scores would be positively associated with healthier dietary behaviors, greater physical activity participation, and higher PedsQL scores across the overall sample, with these associations expected to hold true within both normal-weight and overweight/obese groups. In addition, analyses involving underweight adolescents will be exploratory and descriptive in nature. We will explore whether underweight adolescents show different levels of resilience, health behaviors, and HRQoL compared with adolescents with normal weight.
Read the detailed description
Childhood and adolescent obesity is associated with adverse physical, psychological, and social outcomes, including reduced health-related quality of life (HRQoL). In India, the coexistence of underweight and overweight highlights the need to examine behavioural and psychosocial factors alongside anthropometric measures.
Resilience, defined as the capacity to adapt to stress and challenges, is a multidimensional construct encompassing individual, family, peer, school, and community domains. Internal resilience-related traits such as diet and physical activity self-efficacy, self-esteem, and optimism may influence adolescents' health behaviours and well-being. However, evidence examining these factors together, particularly in relation to weight status among Indian adolescents, remains limited.
This study is a school-based cross-sectional investigation conducted among adolescents aged 14-16 years in Kolkata, India. The primary objective is to assess differences in overall resilience (ARQ49 total score) between normal-weight and overweight/obese adolescents. Secondary objectives include comparing internal resilience-related traits, dietary behaviours, physical activity patterns, and HRQoL (PedsQL), and examining associations among these variables within the overall sample. An exploratory objective assesses similar outcomes among underweight adolescents.
Participants are recruited from public and private secondary schools using non-probability and snowball sampling through existing professional networks. One parent or guardian per adolescent participates to provide data on parental nutrition knowledge and related contextual factors.
Data collection includes validated self-administered questionnaires and anthropometric measurements (height and weight) to calculate BMI-for-age z-scores using international standards. Statistical analyses include group comparisons across weight categories and multivariable models examining associations among resilience, health behaviours, parental factors, and HRQoL, accounting for clustering at the school level.
This study aims to generate context-specific evidence on how psychosocial resilience and behavioural factors relate to weight status and well-being among Indian adolescents.
- Conditions
- Childhood Obesity, Overweight (BMI > 25), Underweight
- Keywords
- psychosocial resilience, self-efficacy, self-esteem, optimism, physical activity, dietary behavior, health related quality of life
- Medical subject headings
- Pediatric Obesity, Overweight, Thinness, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Groups classified based on BMI | Adolescent participants (14-16 years): Participants will be categorized into weight status groups (underweight, normal-weight, overweight/obese) based on BMI-for-age z-scores for analysis. Group 1: Overweight BMI Cut-Off Points (kg/m²) by International Obesity Task Force; IOTF Overweight (including obesity) ≥25.00 Group 2: Obese BMI Cut-Off Points (kg/m²) by International Obesity Task Force; IOTF Obese ≥30.00 Group 3: Normal-weight BMI Cut-Off Points (kg/m²) by International Obesity Task Force; IOTF Normal Weight - 18.5-24.99 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall resilience (ARQ49 total score)
Overall resilience will be assessed using the Adolescent Resilience Questionnaire (ARQ49). The total score will be calculated by summing responses across all items, with higher scores indicating higher levels of psychosocial resilience.
Measured: At baseline (single time-point assessment)
Secondary outcomes (5)
Health-related quality of life (HRQoL)
HRQoL will be assessed using the Pediatric Quality of Life Inventory (PedsQL). Scores will be transformed to a 0-100 scale, with higher scores indicating better quality of life.
Measured: At baseline (single time-point assessment)
Diet and Physical activity self-efficacy
Self-efficacy will be assessed using a validated Diet and Physical Activity Self-Efficacy Scale. The scale includes multiple domains related to confidence in engaging in physical activity and making healthy dietary choices. Subscale scores will be calculated for each domain, with higher scores indicating greater self-efficacy.
Measured: At baseline (single time-point assessment)
Optimism
Optimism will be assessed using the Youth Life Orientation Test (Y-LOT). A total score will be calculated, with higher scores indicating a more optimistic outlook.
Measured: At baseline (single time-point assessment)
Dietary and PA behaviour
Dietary and physical activity behaviour will be assessed using selected items from the Global School-based Student Health Survey (GSHS), including frequency of consumption of key food groups and hours/days of physical activity (weekly/monthy). Responses will be analysed as categorical or frequency-based variables.
Measured: At baseline (single time-point assessment)
Self-esteem
Self-esteem will be measured using the Rosenberg Self-Esteem Scale (RSES). Total scores will be calculated, with higher scores indicating higher self-esteem.
Measured: At baseline (single time-point assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start20 Feb 2023
- Primary completion28 Feb 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 720 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Responsible party
- Sponsor
- Investigators
- Poulami Dasgupta, Principal investigator, Maastricht University/MaastrichtUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648045
- Sponsor's protocol ID
- Resilient Kids
- Status last verified
- Apr 2026
- First submitted
- 22 Nov 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly because the study involves adolescent participants and linked parent data, and open sharing would raise ethical and privacy concerns. De-identified data may be considered upon reasonable request, subject to review by the research team, applicable ethical approvals, and a data-sharing agreement, in accordance with Maastricht University data governance requirements.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Factors Contributing to Obesity (Dietary Behaviour and Physical Activity), Resilience (Dietary and Physical Activity Self-Efficacy, Self- Esteem, General Resilience and Optimism), and HRQoL in Indian Adolescents
- ClinicalTrials.gov ID
- NCT05648045
- Acronym / sponsor ID
- Resilient Kids
- Conditions
- Childhood Obesity, Overweight (BMI > 25), Underweight
- Keywords
- psychosocial resilience, self-efficacy, self-esteem, optimism, physical activity, dietary behavior, health related quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 13 Dec 2022 (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.
A school-based cross-sectional study that aims to generate context-specific evidence on how weight status is related to resilience, health behaviour, and quality of life among Indian adolescents.
Primary Objective
To assess differences in overall resilience (total score of Adolescent Resilience score from ARQ49) between normal-weight and overweight/obese Indian adolescents aged 14-16 years.
Secondary Objectives
- To compare differences in Adolescent Resilience Questionnaire (ARQ49) subscale scores between normal-weight and overweight/obese adolescents. The internal resilience factors assessed by the ARQ49 include confidence, emotional insight, negative cognition, social skills, empathy, and tolerance, while the external resilience factors include family connectedness, family availability, peer connectedness, peer availability, supportive school environment, school connectedness, and community connectedness.
- To assess differences in internal resilience factors (diet self-efficacy, physical activity self-efficacy, self-esteem, and optimism) between normal-weight and overweight/obese adolescents and to examine parental nutrition knowledge as an external resilience resource and moderator in association analyses.
- To compare dietary behaviors, physical activity patterns, and Pediatric Quality of Life Inventory (PedsQL) scores between normal-weight and overweight/obese adolescents.
- To examine the associations among resilience, dietary and physical activity behaviors, and PedsQL within the overall sample and within different weight groups, and to evaluate parental nutrition knowledge as a moderator of the relationship between weight status and resilience or health outcomes. Exploratory Objective
- To explore differences in resilience, health behaviors, and PedsQL between normal-weight and underweight Indian adolescents.
Study hypotheses
The investigators hypothesized that adolescents with overweight/obesity, compared with their normal-weight peers, would demonstrate lower scores on total resilience (primary outcome), as well as on internal and external resilience indices; report lower diet self-efficacy, physical activity self-efficacy, self-esteem, and optimism; report less frequent health-promoting behaviors (including lower fruit and vegetable intake and fewer days achieving ≥ 60 min/day of moderate-to-vigorous physical activity); and report lower PedsQL scores.
Parental nutrition knowledge will not be treated as a between-group outcome; instead, it will be tested as a moderator in association analyses, examining whether parental nutrition knowledge influences the relationship between weight status and resilience or health outcomes.
Furthermore, the investigators hypothesized that higher resilience scores would be positively associated with healthier dietary behaviors, greater physical activity participation, and higher PedsQL scores across the overall sample, with these associations expected to hold true within both normal-weight and overweight/obese groups. In addition, analyses involving underweight adolescents will be exploratory and descriptive in nature. We will explore whether underweight adolescents show different levels of resilience, health behaviors, and HRQoL compared with adolescents with normal weight.
Detailed description
Childhood and adolescent obesity is associated with adverse physical, psychological, and social outcomes, including reduced health-related quality of life (HRQoL). In India, the coexistence of underweight and overweight highlights the need to examine behavioural and psychosocial factors alongside anthropometric measures.
Resilience, defined as the capacity to adapt to stress and challenges, is a multidimensional construct encompassing individual, family, peer, school, and community domains. Internal resilience-related traits such as diet and physical activity self-efficacy, self-esteem, and optimism may influence adolescents' health behaviours and well-being. However, evidence examining these factors together, particularly in relation to weight status among Indian adolescents, remains limited.
This study is a school-based cross-sectional investigation conducted among adolescents aged 14-16 years in Kolkata, India. The primary objective is to assess differences in overall resilience (ARQ49 total score) between normal-weight and overweight/obese adolescents. Secondary objectives include comparing internal resilience-related traits, dietary behaviours, physical activity patterns, and HRQoL (PedsQL), and examining associations among these variables within the overall sample. An exploratory objective assesses similar outcomes among underweight adolescents.
Participants are recruited from public and private secondary schools using non-probability and snowball sampling through existing professional networks. One parent or guardian per adolescent participates to provide data on parental nutrition knowledge and related contextual factors.
Data collection includes validated self-administered questionnaires and anthropometric measurements (height and weight) to calculate BMI-for-age z-scores using international standards. Statistical analyses include group comparisons across weight categories and multivariable models examining associations among resilience, health behaviours, parental factors, and HRQoL, accounting for clustering at the school level.
This study aims to generate context-specific evidence on how psychosocial resilience and behavioural factors relate to weight status and well-being among Indian adolescents.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Groups classified based on BMI | – | –Adolescent participants (14-16 years): Participants will be categorized into weight status groups (underweight, normal-weight, overweight/obese) based on BMI-for-age z-scores for analysis. Group 1: Overweight BMI Cut-Off Points (kg/m²) by International Obesity Task Force; IOTF Overweight (including obesity) ≥25.00 Group 2: Obese BMI Cut-Off Points (kg/m²) by International Obesity Task Force; IOTF Obese ≥30.00 Group 3: Normal-weight BMI Cut-Off Points (kg/m²) by International Obesity Task Force; IOTF Normal Weight - 18.5-24.99 |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- School-going Indian adolescents aged 14 to 16 years, studying in grades 8 to 10 in secondary schools in Kolkata, India. Participants were recruited from public and private schools. One parent or guardian of each participating adolescent was also invited to participate. Weight status categories (underweight, normal weight, and overweight/obese) were defined analytically using BMI-for-age z-scores based on IOTF cut-offs.
Key inclusion criteria (5 listed)
- Adolescents aged 14 to 16 years
- Studying in grades 8, 9, or 10
- Enrolled in participating secondary schools in Kolkata, India
- Able to provide assent, with written consent from a parent or legal guardian
- One parent or guardian willing to participate in the parent survey
Key exclusion criteria (4 listed)
- Age below 14 years or above 16 years
- Not enrolled in grades 8, 9, or 10
- No parental/legal guardian consent or no adolescent assent
- Incomplete eligibility for participation in the survey procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall resilience (ARQ49 total score)
Time frame: At baseline (single time-point assessment)
Overall resilience will be assessed using the Adolescent Resilience Questionnaire (ARQ49). The total score will be calculated by summing responses across all items, with higher scores indicating higher levels of psychosocial resilience.
5 secondary outcomes
Health-related quality of life (HRQoL)
Time frame: At baseline (single time-point assessment)
Diet and Physical activity self-efficacy
Time frame: At baseline (single time-point assessment)
Optimism
Time frame: At baseline (single time-point assessment)
Dietary and PA behaviour
Time frame: At baseline (single time-point assessment)
Self-esteem
Time frame: At baseline (single time-point assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly because the study involves adolescent participants and linked parent data, and open sharing would raise ethical and privacy concerns. De-identified data may be considered upon reasonable request, subject to review by the research team, applicable ethical approvals, and a data-sharing agreement, in accordance with Maastricht University data governance requirements.
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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. This study is not recruiting at the moment.
Poulami Dasgupta principal investigator
Maastricht University/MaastrichtUMC
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Obesity and Overweight (BMI > 25), run by Maastricht University Medical Center at 16 sites in India.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall resilience (ARQ49 total score) (time frame: At baseline (single time-point assessment)). 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 29 Apr 2026.