Clinical Trial

Indigenous Nutritional Supplements for Pregnancy to Improve Resilience in Environmental Heat

Study acronym: INSPIRE
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07489664
Lead Sponsor Aga Khan University
Collaborators: Bill and Melinda Gates Foundation
Conditions Heat Stress, Pregnancy, Women of Reproductive Age, Nutrition Status
Enrollment 292 participants
Start Date 2026-03
Primary Completion 2028-03 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-24