NCT05648045

Brief 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. 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

  1. 1.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.
  2. 2.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.
  3. 3.To compare dietary behaviors, physical activity patterns, and Pediatric Quality of Life Inventory (PedsQL) scores between normal-weight and overweight/obese adolescents.
  4. 4.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.
  5. 5.To explore differences in resilience, health behaviors, and PedsQL between normal-weight and underweight Indian adolescents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 20, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

November 22, 2022

Last Update Submit

April 23, 2026

Conditions

Keywords

psychosocial resilienceself-efficacyself-esteemoptimismphysical activitydietary behaviorhealth related quality of life

Outcome Measures

Primary Outcomes (1)

  • 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.

    At baseline (single time-point assessment)

Secondary Outcomes (5)

  • Health-related quality of life (HRQoL)

    At baseline (single time-point assessment)

  • Diet and Physical activity self-efficacy

    At baseline (single time-point assessment)

  • Optimism

    At baseline (single time-point assessment)

  • Dietary and PA behaviour

    At baseline (single time-point assessment)

  • Self-esteem

    At baseline (single time-point assessment)

Study Arms (1)

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

Eligibility Criteria

Age14 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Mitra Institution (Main)

Kolkata, West Bengal, 700009, India

Location

Victoria Institution High School

Kolkata, West Bengal, 700009, India

Location

Ballygunge Government High School

Kolkata, West Bengal, 700020, India

Location

Andhra Association High School (AAHS)

Kolkata, West Bengal, 700026, India

Location

Lycee School

Kolkata, West Bengal, 700029, India

Location

National High School For Boys

Kolkata, West Bengal, 700029, India

Location

National High School For Girls

Kolkata, West Bengal, 700029, India

Location

Tollygunge Adarsh Hindi High School (Girls and Boys)

Kolkata, West Bengal, 700033, India

Location

New Alipore Multipurpose School

Kolkata, West Bengal, 700053, India

Location

New Vista Academy

Kolkata, West Bengal, 700063, India

Location

Sakhawat Memorial Govt. Girls' High School

Kolkata, West Bengal, 700071, India

Location

Calcutta Public School, Bidhan Park

Kolkata, West Bengal, 700090, India

Location

Indus Valley World School

Kolkata, West Bengal, 700094, India

Location

Calcutta Public School, Kalikapur

Kolkata, West Bengal, 700099, India

Location

Holy Mission school

Kolkata, West Bengal, India

Location

St. Joseph and Mary's school

Kolkata, West Bengal, India

Location

MeSH Terms

Conditions

Pediatric ObesityOverweightThinnessMotor Activity

Condition Hierarchy (Ancestors)

ObesityOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Poulami Dasgupta

    Maastricht University/MaastrichtUMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2022

First Posted

December 13, 2022

Study Start

February 20, 2023

Primary Completion

February 28, 2024

Study Completion

April 30, 2024

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations