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Indigenous Nutritional Supplements for Pregnancy to Improve Resilience in Environmental Heat

NCT07489664 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2026-03-24

No results posted yet for this study

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.

Conditions

  • Heat Stress
  • Pregnancy
  • Women of Reproductive Age
  • Nutrition Status

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.

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Aga Khan University

    lead OTHER

Principal Investigators

  • Junaid Iqbal, PhD · Aga Khan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2028-03-31
Completion
2028-12-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07489664 on ClinicalTrials.gov