Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05648045 |
| Other study ID # |
Resilient Kids |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 20, 2023 |
| Est. completion date |
March 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Maastricht University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
This is a cross-sectional observational study where investigators are trying to see the
associations between factors contributing to obesity (dietary behavior and physical
activity), resilience (self-efficacy, self-esteem, and optimism), and HRQoL in Indian
adolescents.
The key research question and sub-questions are as follows:
Main research question: Is there a relationship between resilience (measured as
self-efficacy) and obesity in children?
1. What is the level of other resilience factors (measured as self-esteem and optimism)
among overweight, obese, and normal-weight adolescents? Are there differences between
the groups? Are there differences between ages? Are there differences between genders?
2. Is there a relationship between resilience factors (measured as self-esteem and
optimism) and HRQoL among overweight, obese, and normal-weight adolescents? Are there
differences between the groups? Are there differences between ages? Are there
differences between genders?
3. Is low resilience (measured as self-esteem, self-efficacy, and optimism) associated with
overweight or obesity among adolescents and a lower HRQoL? Are there differences between
ages? Are there differences between genders?
4. What is the level of association between resilience (identified as self-esteem,
self-efficacy, and optimism) and factors contributing to obesity (dietary habits -
measured in terms of more frequent unhealthy eating, such as eating fast food, sugary
beverages, more calories, and less frequent healthy habits, such as more junk foods for
meals, less physical activity, higher BMI, or higher weight-for-age Z scores, more body
fat percentage and psychosocial factors related to obesity: socio-economic status
Description:
Childhood obesity is associated with increased health risks in adulthood, affecting capacity
for physical activity and occupational performance, as well as psychological and social
deficits. These are significant contributors to direct and indirect costs. The prevalence of
obesity and related factors in young children emphasizes the importance of understanding
periods of vulnerability in early development and the interaction between physical activity,
resilience, and HRQoL. Factors for preventing obesity are social support and a person's
willingness to lifestyle changes (Gilchrist & Zametkin, 2006). With many adverse effects of
adolescent obesity, one's resilience (self-esteem, self-efficacy, and optimism) may
contribute to being protective, ultimately influencing the individual's overall
health-related quality of life. However, to the investigator's knowledge, resilience
(self-esteem, self-efficacy, and optimism) has not been explored from the perspective of
factors that contribute to obesity (dietary habits, physical activity, perceived stress, and
psychosocial factors) in Indian adolescents. The study aims to identify the relationship
between resilience to obesity factors in Indian adolescents. The main aim of this study is to
see the correlation of resilience, identified as self-esteem, self-efficacy, and optimism,
with factors influencing the development of obesity (dietary habits, physical activity,
perceived stress, and psychosocial factors) in Indian children/adolescents. In this
cross-sectional study, samples will be recruited from sites where other influencing factors
can be controlled, like either from a school (where investigators can control for
socioeconomic background, education, etc.) or from an obesity clinic in the city, after
ensuring the case is a newly refereed one, who has not been given any intervention that might
interfere with their resilience.
The current study findings may lead to a holistic understanding of obesity-contributing
factors, such as dietary habits, physical activity, perceived stress, and psychosocial
factors, and their relationship with resilience and HRQoL. Increased knowledge of these
factors may lead to more comprehensive studies involving resilience and obesity and also
study if the early resilience-building intervention can potentially lower the chances of
developing obesity in adolescents. Results from the study can also help build more effective
programs for health professionals and nutritionists striving to reduce or prevent obesity
among adolescents. Investigator/s also aim to use their data further to develop an
intervention to strengthen resilience among these children. Investigator/s further aim to
compare their findings to a small group of age-sex-matched Dutch children.
All participants will be given the information sheets and consent forms that require both
participant's permission and parental consent that will be collected before the beginning of
data collection. In addition, the primary researcher will clarify any questions/doubts by the
participant and/or the parents.
Participant recruitment process in India:
The primary researcher (Ph.D. student) is currently working towards obtaining permission from
two local bodies here in Kolkata, India. The first permission is to be obtained from the
District Inspector (DI) of Schools (for both government and private schools), Kolkata, West
Bengal (India), and the second one is from the local member of the Legislative Assembly (MLA)
(Member of Lok Sabha for Kolkata Dakshin/South) office. This permission is required based on
the control of the MLA on the local school clusters (mainly government schools). Kolkata
Municipal Corporation (abbreviated KMC; also Calcutta Municipal Corporation) is the local
government of the Indian city of Kolkata, the state capital of West Bengal. This civic
administrative body administers an area of 206.08 square kilometers (79.57 sq mi).
The city is divided into 144 administrative wards that are grouped into 16 boroughs. Each of
these wards elects a councilor to the Kolkata Municipal Corporation. Each borough has a
committee consisting of the councilors elected from the respective wards of the boroughs.
Through the borough committees, the corporation maintains government-aided schools,
hospitals, and municipal markets and partakes in urban planning and road maintenance. As the
apex body, the corporation discharges its function through the Mayor-in-Council, consisting
of a mayor, assisted by a deputy mayor, and ten other elected members of the KMC. The mayor
is responsible for the overall functioning of the KMC and has a tenure of five years. The All
India Trinamool Congress currently holds power in the KMC. Schools across cities in India are
divided into clusters. For example, Kolkata Municipality is a block in the Kolkata district
of West Bengal with about 94 clusters (approximately, an exact list can be obtained from the
DI office in due course). All the government and private schools of the Kolkata Municipality
block are divided into different clusters of schools.
Ward No. 88, Kolkata Municipal Corporation is an administrative division of Kolkata Municipal
Corporation in Borough No. 9, covering parts of the Kalighat (Sahanagar-Lalpara) neighborhood
in South Kolkata, in the Indian state of West Bengal. For the current study, the local MLA
(Ms. Mala Roy), who controls ward number 88, permission will be taken. Every city resident
belongs to an individual ward based on the location of their residence and voting
eligibility. In this case, based on the primary researcher's area of residence, it is Ward
No. 88, Kolkata Municipal Corporation.
Once the local permission is obtained, a complete list of schools covered under Ward No. 88,
Kolkata Municipal Corporation, will be provided by the local MLA/DI office. Schools from this
list will then be selected through randomization. The number of schools chosen will depend on
the total sample size for the study. Both private and government schools will be selected.
After completing the school selection, the researcher will visit each school and meet the
school principal to brief about the research study. If any school refuses to participate, the
investigator/s will move on to the next randomized school on the list.
