- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05648045
Weight Status, Resilience, and Quality of Life in Indian Children
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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West Bengal
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Kolkata, West Bengal, India, 700009
- Mitra Institution (Main)
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Kolkata, West Bengal, India, 700009
- Victoria Institution High School
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Kolkata, West Bengal, India, 700020
- Ballygunge Government High School
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Kolkata, West Bengal, India, 700026
- Andhra Association High School (AAHS)
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Kolkata, West Bengal, India, 700029
- Lycee School
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Kolkata, West Bengal, India, 700029
- National High School For Boys
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Kolkata, West Bengal, India, 700029
- National High School For Girls
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Kolkata, West Bengal, India, 700033
- Tollygunge Adarsh Hindi High School (Girls and Boys)
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Kolkata, West Bengal, India, 700053
- New Alipore Multipurpose School
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Kolkata, West Bengal, India, 700063
- New Vista Academy
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Kolkata, West Bengal, India, 700071
- Sakhawat Memorial Govt. Girls' High School
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Kolkata, West Bengal, India, 700090
- Calcutta Public School, Bidhan Park
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Kolkata, West Bengal, India, 700094
- Indus Valley World School
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Kolkata, West Bengal, India, 700099
- Calcutta Public School, Kalikapur
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Kolkata, West Bengal, India
- Holy Mission school
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Kolkata, West Bengal, India
- St. Joseph and Mary's school
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
|---|
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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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall resilience (ARQ49 total score)
Time Frame: At baseline (single time-point assessment)
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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.
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At baseline (single time-point assessment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health-related quality of life (HRQoL)
Time Frame: At baseline (single time-point assessment)
|
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.
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At baseline (single time-point assessment)
|
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Diet and Physical activity self-efficacy
Time Frame: At baseline (single time-point assessment)
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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.
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At baseline (single time-point assessment)
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Optimism
Time Frame: At baseline (single time-point assessment)
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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.
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At baseline (single time-point assessment)
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Dietary and PA behaviour
Time Frame: At baseline (single time-point assessment)
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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.
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At baseline (single time-point assessment)
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Self-esteem
Time Frame: At baseline (single time-point assessment)
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Self-esteem will be measured using the Rosenberg Self-Esteem Scale (RSES).
Total scores will be calculated, with higher scores indicating higher self-esteem.
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At baseline (single time-point assessment)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Poulami Dasgupta, Maastricht University/MaastrichtUMC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
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
- Resilient Kids
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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