Secular Trends in the Prevalence of Cardiometabolic Risk Factors Among Teenage School Children in Urban South India

NCT04015726 | Unknown DMC

• 1 other identifier: IDRFARH012
• Study Type: observational
• Target: 2,815
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of cardiometabolic risk is high among South Asians which manifests itself at an early age. Studies have reported that unhealthy food choices, inadequate physical activity and lack of awareness on healthy lifestyle practices pose a huge threat to the increasing prevalence of metabolic abnormalities even at adolescence. In an earlier study conducted in 2006, reported that 68% of the children during their early adolescence had one or more of the cardiometabolic abnormalities such as obesity, central adiposity, increased blood pressure and presence of dysglycaemia and dyslipidaemia. The risk escalated with increasing weight. Therefore, it is imperative to sensitize the children on improving their lifestyle by conducting screening tests and health education programmes in schools by involving teachers. The Investigator have also shown in a study that teachers can be instrumental in imparting knowledge on the prevention of non-communicable diseases such as diabetes by promoting healthy behavioral changes. The proposed study will focus on a) changes in the prevalence of cardiometabolic risk factors over a 10 year period b) health education programme to school children c) recommendations to school teachers (tool-kit) to inculcate improved lifestyle practices to their students.

Conditions

Obesity; Dysglycemia; Dyslipidemias; Hypertension; Insulin Resistance

Outcome Measures

Primary Outcomes (5)

• Prevalence of central adiposity

  Among adolescent children in 2019 in comparison with 2006 data

  baseline

• Prevalence of dysglycemia

  Among adolescent children in 2019 in comparison with 2006 data

  Baseline

• Prevalence of dyslipidemia

  Among adolescent children in 2019 in comparison with 2006 data

  Baseline

• Prevalence of hypertension

  Among adolescent children in 2019 in comparison with 2006 data

  Baseline

• Prevalence of insulin resistance

  Among adolescent children in 2019 in comparison with 2006 data

  Baseline

Secondary Outcomes (4)

• Prevalence of overweight

  Baseline

• Prevalence of obesity

  Baseline

• Changes in diet habit

  Baseline

• Changes in duration of physical activity

  Baseline

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children both boys and girls between 12 - 18yrs age group

You may qualify if:

• Children both boys and girls between 12 - 18yrs age group
• Parents and child willing to give informed consent
• Children must be available for and willing to attend all evaluation visits
• Willingness to follow the protocol requirements as evidenced by written informed consent

You may not qualify if:

• Children below the age of 12 years and above the age of 18 years
• Parents or Child who is not willing to participate in the study

Sponsors & Collaborators

• India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals: lead

Study Sites (1)

India Diabetes Research Foundation

Chennai, Tamil Nadu, 600008, India

RECRUITING

MeSH Terms

Conditions

Obesity; Dyslipidemias; Hypertension; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases; Hyperinsulinism; Glucose Metabolism Disorders

Study Officials

• Ambady Ramachandran, MD, PhD, DSc

  Senior Research Officer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ambady Ramachandran, MD, PhD, DSc

CONTACT

04422353730; research@ardiabetes.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2019
• First Posted: July 11, 2019
• Study Start: August 1, 2019
• Primary Completion: August 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 24, 2020

Record last verified: 2020-11

Locations

IN (1)