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NOT YET RECRUITING
NCT07489664
NA

Indigenous Nutritional Supplements for Pregnancy to Improve Resilience in Environmental Heat

Sponsor: Aga Khan University

View on ClinicalTrials.gov

Summary

The purpose of this study is to learn whether a simple, traditional, and balanced meal made from local foods, eaten once a day during pregnancy, can help women in rural Pakistan stay healthier in hot weather and give birth to healthier babies. Climate change has made heat a serious challenge for pregnant women, especially in areas with limited resources. This study will explore whether an indigenous meal that is culturally acceptable and easy to prepare can improve resilience to heat stress and support better outcomes for both mothers and newborns. The study will focus on two main questions: * Can this daily balanced meal reduce the harmful effects of heat stress during pregnancy? * Does it improve newborn health, especially birth weight? Researchers will compare women who eat the balanced local meal every day with women who continue their usual meals. They will check changes in women's health, levels of key vitamins and nutrients, and their babies' birth outcomes. During the study, participants will: * Either eat the balanced local meal daily or continue their usual meals. * Share information on their health, diet, and heat exposure. * Provide small samples, such as blood and stool, to study nutrient levels and gut health. * Have their newborns' health and growth measured at birth.

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

292

Start Date

2026-03

Completion Date

2028-12

Last Updated

2026-03-24

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Indigenous Balanced Diet Arm

The uniqueness of this intervention lies in its culturally-preservative approach, its novel target of heat stress, its timing (preconception), and its integrated process (nutritionist collaboration + overall dietary counseling). It specifically targets heat resilience in pregnancy through a holistic approach of adapting dietary intervention as mitigating strategy for providing resilience to heat stress and evaluating key hypothesized pathways responsible for combating adverse pregnancy outcomes by this intervention.

Locations (1)

Aga Khan University

Karachi, Pakistan