Indigenous Nutritional Supplements for Pregnancy to Improve Resilience in Environmental Heat (NCT07489664) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Indigenous Nutritional Supplements for Pregnancy to Improve Resilience in Environmental Heat
Pakistan292 participantsStarted 2026-03
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion criteria
✓. Women aged 18-45 years belonging to a low to middle socioeconomic status, residing in Mithi, Districts in Sindh.
✓. Planning to conceive within the study time frame and expect to become pregnant within four months of starting nutritional intervention.
✓. Women who confirm their pregnancy during the first trimester i.e., before 8 weeks of gestational age.
Exclusion criteria
✕. Women using long-lasting contraceptives such as IUDs, implants, and injectable methods like Depo-Provera.
✕. Women with a history of multiple miscarriage or stillbirths.
✕. Women with known chronic diseases, such as cardiovascular disorders, hepatic disorders, renal disorders, and infectious diseases.
✕. Women suffering from severe malnutrition (WHO: Underweight i.e., having BMI \< 16 Kg/m2 or obese having BMI ≥ 30 Kg/m2).
✕. Women having severe anemia (WHO: Severe anemia i.e., Hb \< 7g/dL).
✕
What they're measuring
1
Difference in proportion of neonates with low Weight-for-Gestational-Age Z-score (WGAZ< -2 SD) at birth between intervention and control arms.
Timeframe: Within 24 hours of delivery
2
Difference in proportion of neonates with low height-for-Gestational-Age Z-score (LGAZ< -2 SD) at birth between intervention and control arms.
. Women currently enrolled in BISP supplementation programs or taking any supplements other than iron and folic acid (IFA) will be excluded from the study.
✕. Those who do not become pregnant within three months of supplementation during pre-conception.