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School-Based Healthy Heart Program for Lipid Disorders among adolescents in Low-Resource Settings

School-Based Healthy-Heart Intervention for Early Lipid Disorders among Adolescents (SHIELD-A): Addressing barriers and contextualizing intervention for effective implementation in resource-limited settings - SHIELD-A

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099806
Enrollment
1680
Registered
2025-12-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Lifestyle & Behavioural Intervention: School-based lifestyle intervention targeting key modifiable behaviors such as moderate-to-vigorous physical activity (MVPA) and combined with mind

Sponsors

Dr M Kalaivani
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All student studying in grades 6-8 aged under 18 years, able to provide informed assent to participate and supported by parental consent. Physically fit for assessment of physical activity will be recruited in the study.

Exclusion criteria

Exclusion criteria: Children with known history (self-reported) of chronic systemic illness and on medication for the chronic illnesses. Having major physical deformity. Any condition precluding anthropometric measurements (e.g., knee injury, leg fracture, etc.) at the time of assessment. Adolescents unable to communicate clearly (e.g., due to a speech, learning or hearing disability) will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
Change in dyslipidemia prevalence.Timepoint: Baseline and at 6 months

Secondary

MeasureTime frame
Mean difference in BMI and waist circumference, mean change in systolic and diastolic blood pressure, mean change in fasting plasma glucose, mean change in hs-CRP, mean difference in adiponectin, leptin, ghrelin, mean change in apo-A and apo-B, and SHIED-A intervention adherence using physical activity and sedentariness (GPAQ), dietary patterns and nutritional intake (semi quantitative FFQ), tobacco and alcohol use, psychological well-being (depression, stress, anxiety (PHQ-9 and GAD-7)), Screen time (STQ), and sleep hygiene.Timepoint: For blood related parameters: Before and after intervention. For behavioral parameters: At every 6 months (6 measurements).

Countries

India

Contacts

Public ContactDr M Kalaivani

All India Institute of Medical Sciences (AIIMS), New Delhi

manikalaivani@gmail.com9717319082

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026