Indigenous Nutritional Supplements for Pregnancy to Improve Resilience in Environmental Heat

NCT07489664 | Not Yet Recruiting DMC

• 2 other identifiers: 10697-33069074884
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Local Food-Based Diet to Improve Birth Outcomes and Heat Resilience in Pregnant Women; maternal depression; placental transcriptomics; microbiome

Outcome Measures

Primary Outcomes (2)

• Difference in proportion of neonates with low Weight-for-Gestational-Age Z-score (WGAZ< -2 SD) at birth between intervention and control arms.

  Neonatal birth weight (grams) will be measured using a digital infant weighing scale within 24 hours of birth. Birth weight will be converted into WGAZ using WHO 2013 sex- and gestational age-specific reference standards. The percentage of neonates with low WGAZ (\< -2 SD) will be calculated for both supplemented and non-supplemented groups, and comparisons between groups will be made using appropriate statistical methods, adjusting for maternal heat stress exposure. Unit of Measure: % of neonates with WGAZ \< -2 SD

  Within 24 hours of delivery

• Difference in proportion of neonates with low height-for-Gestational-Age Z-score (LGAZ< -2 SD) at birth between intervention and control arms.

  Neonatal birth height (cm) will be measured using a standardized neonate's height scale within 24 hours of birth. Birth height will be converted into LGAZ using WHO 2013 sex- and gestational age-specific reference standards. The percentage of neonates with low LGAZ (\< -2 SD) will be calculated for both supplemented and non-supplemented groups, and comparisons between groups will be made using appropriate statistical methods, adjusting for maternal heat stress exposure. Unit of Measure: % of neonates with LGAZ \< -2 SD

  Within 24 hours of delivery

Secondary Outcomes (13)

• Gestational age at delivery

  At delivery date

• Mode of delivery

  At delivery

• Maternal serum ferritin concentration

  Evaluated at the end of each trimester (within one week before or after the scheduled time point), from enrollment until delivery.

• Maternal serum folate concentration

  Evaluated at the end of each trimester (within one week before or after the scheduled time point), from enrollment until delivery.

• Maternal serum 25-hydroxyvitamin D concentration

  Evaluated at the end of each trimester (within one week before or after the scheduled time point), from enrollment until delivery.

Study Arms (2)

Indigenous Balanced Diet Arm

OTHER

Participants in this arm will receive minimally modified culturally-tailored indigenous heat-mitigating balanced diet as once a day meal starting from at least one month before conception and throughout the pregnancy till delivery.

Dietary Supplement: Indigenous Balanced Diet Arm

Usual Diet Arm

NO INTERVENTION

Pregnant women in this arm will continue with their usual diet, and receives standard antenatal care.

Interventions

Indigenous Balanced Diet Arm DIETARY_SUPPLEMENT

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.

Indigenous Balanced Diet Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: women of reproductive age
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Aga Khan University: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Aga Khan University

Karachi, 74800, Pakistan

Location

Related Publications (27)

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Related Links

• Trends in maternal mortality 2000 to 2020: estimates by WHO, UNICEF, UNFPA, World Bank Group and UNDESA/Population Division
• Climate change impacts on health
• Climate Change Profile of Pakistan
• Key findings report of National Nutrition Survey of Pakistan 2018
• Malnutrition in women
• Haemoglobin concentrations for the diagnosis of anaemia and assessment of severity
• What are the chances of getting pregnant the first time trying?
• Deaths mount as Pakistan swelters in heatwave

MeSH Terms

Conditions

Heat Stress Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Junaid Iqbal, PhD

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junaid Iqbal, PhD

CONTACT

+923353189185; junaid.iqbal@aku.edu

Kehkashan Begum Hussain, MS

CONTACT

+923368906517; kehkashan.begum@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: single-blind approach (Investigator and Outcomes Assessor Blinding): The investigators and outcome assessors will remain unaware of the group assignments. They will not be involved in the preparation or distribution of the intervention meals to ensure that their observations and assessments remain unbiased. However, participants will not be blinded, as they will be aware of whether they are receiving the indigenous balanced diet or continuing their usual meals.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (Research), Department of Paediatrics & Child Health.

Model Details: The study uses a two-arm parallel design to compare heat stress associated pregnancy and birth outcomes between the pregnant women receiving the culturally-tailored meal (intervention group) and the control group following their usual diet.

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: March 24, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)