Heat StressINSPIRENCT07489664
Indigenous Nutritional Supplements for Pregnancy to Improve Resilience in Environmental Heat
A study testing Indigenous Balanced Diet Arm in people with Heat Stress and Pregnancy, run by Aga Khan University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Heat Stress, Pregnancy, Women of Reproductive Age
- What is being tested?
- Indigenous Balanced Diet Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 sitePakistan
- Study dates
- Mar 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Aga Khan University
Karachi, 74800
Junaid Iqbal, PhD, 00922134861648, junaid.iqbal@aku.edu
Kehkashan Begum, MS, 00922134864088, kehkashan.begum@aku.edu
About this study
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:
Read more
- 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.
Read the detailed description
This study will use a quasi-experimental design to study if the effects of an indigenous heat-mitigating balanced dietary intervention on maternal health and neonatal development when implemented from preconception to delivery in a region with high temperatures.
The study will recruit 292 women of reproductive age who plan to become pregnant and assign them to either the intervention group or the comparison group in a 1:1 ratio. The intervention group will receive one customized indigenous heat-mitigating balanced diet as daily lunch meal (~1,000 kilocalories). The comparison group will continue their usual dietary practices while receive routine antenatal care and dietary counseling services according to national guidelines.
The intervention diet plans have been designed through review of dietary recommendations and published evidence, combined with community consultations to ensure feasibility and cultural acceptability. The food choices were established according to three criteria which required foods to have high nutrient content and be affordable and accessible within the local area. The meal composition includes whole grains, lentils, legumes, green leafy vegetables, dairy products, fermented foods, fish, and other culturally acceptable animal-source foods. A 14-day rotating menu will be implemented. The intervention will begin at least one month prior to conception and continue until delivery.
Meals will be prepared in kitchen in field site's office set up specially for meals preparation. Local chefs will be hired and counselled to prepare meals ensuring proper hygiene and following study's diet plans. Study data collectors will distribute meals to the participants. The team will use attendance records, intervention adherence forms, telephone follow-up and home visits to monitor intervention delivery. The team will organize home delivery services when they become essential.
The research team will evaluate maternal health at the end of each trimester starting from the time of conception until the end of pregnancy. Data will be collected through three different methods which include anthropometer, vitals assessments and testing blood samples for hemoglobin levels using point of care testing device (HemoCue 301+) and specific micronutrients \& inflammatory markers (Vitamin A, D, B9, B12, Zinc, Ferritin and CRP). The research team will collect stool samples to investigate gut microbiome composition through molecular techniques. The study will use weather stations, thermal drone cameras and wearable devices (FitBit) to measure heat exposure while linking those measurements to local weather patterns.
At delivery, neonatal anthropometric measurements will be obtained using standardized procedures. Study staff will collect cord blood samples which will then undergo biomarker analysis. Moreover, placental tissues will be collected for both gross examination and transcriptomic analysis.
For safety purposes, all individuals will be monitored carefully for food allergies by conducting regular assessments and establishing health facility connections to treat any medical complications. The study allows participants to join voluntarily while they maintain their right to leave at any moment without losing access to standard medical treatment.
The study has received ethical approval from the Aga Khan University Ethical Review Committee (Reference: 2024-10697-3239) and the National Bioethics Committee of Pakistan (Reference: 4-87/NBCR-1220/24-25/836). Written informed consent will be obtained prior to enrollment. Data will be managed in accordance with institutional confidentiality and data protection policies.
- Conditions
- Heat Stress, Pregnancy, Women of Reproductive Age, Nutrition Status
- Being tested
- Indigenous Balanced Diet Arm
- Keywords
- Local Food-Based Diet to Improve Birth Outcomes and Heat Resilience in Pregnant Women, maternal depression, placental transcriptomics, microbiome
- Medical subject headings
- Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indigenous Balanced Diet ArmDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Within 24 hours of delivery
Secondary outcomes (13)
Gestational age at delivery
Gestational age will be determined based on first-trimester ultrasound and/or last menstrual period (LMP).
Unit of Measure: Weeks
Measured: At delivery date
Mode of delivery
Mode of delivery will be recorded as vaginal or cesarean section. Unit of Measure: Percentage (%) of cesarean deliveries
Measured: At delivery
Maternal serum ferritin concentration
Maternal serum ferritin will be measured using standardized immunoturbidimetric assay on an automated chemistry analyzer.
Unit of Measure: ng/mL
Measured: 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
Maternal serum folate will be measured using standardized laboratory assay on automated immunoassay analyzer.
Measured: 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
Maternal serum 25-hydroxyvitamin D concentration will be measured using standardized laboratory assay on automated immunoassay analyzer.
Unit of Measure: ng/mL
Measured: Evaluated at the end of each trimester (within one week before or after the scheduled time point), from enrollment until delivery.
Generalized anxiety symptoms
Maternal mental health will be assessed using a validated psychological questionnaires Generalized Anxiety Disorder-7 (GAD-7) for assessing generalized anxiety symptoms over the past two weeks.
Unit of Measure: The scale comprises 7 items, each rated on a 4-point Likert scale from 0 (not at all) to 3 (almost every day), with a total score ranging from 0 to 21.
Interpretation: A score of 15 or higher is indicative of severe anxiety.
Measured: Evaluated at the end of each trimester (within one week before or after the scheduled time point), from enrollment until delivery.
Maternal gut microbiome alpha diversity
Alpha diversity of maternal gut microbiome will be assessed using 16S rRNA gene sequencing of stool samples.
Unit of Measure: Shannon diversity index
Measured: Evaluated at the end of each trimester (within one week before or after the scheduled time point), from enrollment until delivery.
Placental gene expression levels
Placental gene expression will be quantified using RNA sequencing. Expression levels will be reported as normalized transcript counts.
Unit of Measure: Normalized transcript counts
Measured: At delivery
Estimated fetal weight during pregnancy
Estimated fetal weight will be calculated using ultrasound biometric measurements according to standard obstetric formulas.
Unit of Measure: Grams
Measured: Evaluated at the end of each trimester (within one week before or after the scheduled time point), from enrollment until delivery.
Perceived stress score
Perceived Stress Scale-10 (PSS-10) to assess perceived stress over the past month.
Unit of Measure: The scale consists of 10 items, each rated on a 5-point Likert scale from 0 (never) to 4 (very often), with a total score ranging from 0 to 40.
Interpretation: A score of 27 or higher indicates higher perceived stress.
Measured: Assessed at enrollment (baseline), monthly during pregnancy, and postpartum (after 2 weeks of delivery).
Postnatal depression symptoms
Edinburgh Postnatal Depression Scale (EPDS) to assess postnatal depression symptoms over the past week.
Unit of Measure: The scale comprises 10 items, each rated on a 4-point Likert scale from 0 (no) to 3 (yes), with a total score ranging from 0 to 30.
Interpretation: A score of 13 or greater is indicative of postnatal depression.
Measured: Assessed at enrollment (baseline), monthly during pregnancy, and postpartum (after 2 weeks of delivery).
Depression symptoms
Patient Health Questionnaire-9 (PHQ-9) to assess depression symptoms over the past two weeks.
Unit of Measure: The scale consists of 9 items, each rated on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day), with a total score ranging from 0 to 27.
Interpretation: A score of 10 or greater indicates moderate to severe depression.
Measured: Assessed at enrollment (baseline), monthly during pregnancy, and postpartum (after 2 weeks of delivery).
Combined Depression, Anxiety, and Stress score
Depression, Anxiety, and Stress Scale-21 (DASS-21) to Assesses depression, anxiety, and stress over the past week.
Unit of Measure: The scale consists of 21 items, divided into three subscales, each rated on a 4-point Likert scale from 0 (did not apply to me at all) to 3 (applied to me most of the time). Each subscale score is multiplied by 2 to match the original DASS-42 format.
Interpretation: A score of 14 or greater is indicative of moderate to severe depression, anxiety, and stress.
Measured: Assessed at enrollment (baseline), monthly during pregnancy, and postpartum (after 2 weeks of delivery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Heat StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Junaid Iqbal, Aga Khan University
- Investigators
- Junaid Iqbal, PhD, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489664
- Sponsor's protocol ID
- 10697-33069
- Other IDs
- 074884
- Acronym
- INSPIRE
- Status last verified
- Feb 2026
- First submitted
- 28 Nov 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be made available to anyone including other researchers. Participant confidentiality and privacy protection will be given utmost importance as even anonymized data could have potential indirect identifiers due to the particular locality of the study in a specific rural community, which may lead to the re-identification of participants and may damage the reputation of the community, or stigmatize the participants. Informed consent was also not obtained from the participants regarding sharing of personal data with the public. Thus, we will prioritize our ethical commitment by only making available results of the study in aggregated group format.
Publications
Gonzalez-Fernandez D, Muralidharan O, Neves PA, Bhutta ZA. Associations of Maternal Nutritional Status and Supplementation with Fetal, Newborn, and Infant Outcomes in Low-Income and Middle-Income Settings: An Overview of Reviews. Nutrients. 2024 Oct 31;16(21):3725. doi: 10.3390/nu16213725.
PubMed 39519557Unger HW, Ashorn P, Cates JE, Dewey KG, Rogerson SJ. Undernutrition and malaria in pregnancy - a dangerous dyad? BMC Med. 2016 Sep 19;14(1):142. doi: 10.1186/s12916-016-0695-2.
PubMed 27645498Lakhoo DP, Brink N, Radebe L, Craig MH, Pham MD, Haghighi MM, Wise A, Solarin I, Luchters S, Maimela G, Chersich MF; Heat-Health Study Group; HIGH Horizons Study Group. A systematic review and meta-analysis of heat exposure impacts on maternal, fetal and neonatal health. Nat Med. 2025 Feb;31(2):684-694. doi: 10.1038/s41591-024-03395-8. Epub 2024 Nov 5.
PubMed 39500369Taylor A. ABC of subfertility: extent of the problem. BMJ. 2003 Aug 23;327(7412):434-6. doi: 10.1136/bmj.327.7412.434. No abstract available.
PubMed 12933733Sheikh S, Qureshi RN, Raza F, Memon J, Ahmed I, Vidler M, Payne BA, Lee T, Sawchuck D, Magee L, von Dadelszen P, Bhutta Z; CLIP Working Group. Self-reported maternal morbidity: Results from the community level interventions for pre-eclampsia (CLIP) baseline survey in Sindh, Pakistan. Pregnancy Hypertens. 2019 Jul;17:113-120. doi: 10.1016/j.preghy.2019.05.016. Epub 2019 May 17.
PubMed 31487626Kuehn L, McCormick S. Heat Exposure and Maternal Health in the Face of Climate Change. Int J Environ Res Public Health. 2017 Jul 29;14(8):853. doi: 10.3390/ijerph14080853.
PubMed 28758917Shankar K, Ali SA, Ruebel ML, Jessani S, Borengasser SJ, Gilley SP, Jambal P, Yazza DN, Weaver N, Kemp JF, Westcott JL, Hendricks AE, Saleem S, Goldenberg RL, Hambidge KM, Krebs NF. Maternal nutritional status modifies heat-associated growth restriction in women with chronic malnutrition. PNAS Nexus. 2023 Jan 27;2(1):pgac309. doi: 10.1093/pnasnexus/pgac309. eCollection 2023 Jan.
PubMed 36744021Ramirez JD, Maldonado I, Mach KJ, Potter J, Balise RR, Santos H. Evaluating the Impact of Heat Stress on Placental Function: A Systematic Review. Int J Environ Res Public Health. 2024 Aug 22;21(8):1111. doi: 10.3390/ijerph21081111.
PubMed 39200720Grzeszczak K, Lanocha-Arendarczyk N, Malinowski W, Zietek P, Kosik-Bogacka D. Oxidative Stress in Pregnancy. Biomolecules. 2023 Dec 9;13(12):1768. doi: 10.3390/biom13121768.
PubMed 38136639Brett KE, Ferraro ZM, Yockell-Lelievre J, Gruslin A, Adamo KB. Maternal-fetal nutrient transport in pregnancy pathologies: the role of the placenta. Int J Mol Sci. 2014 Sep 12;15(9):16153-85. doi: 10.3390/ijms150916153.
PubMed 25222554Bremner JD, Moazzami K, Wittbrodt MT, Nye JA, Lima BB, Gillespie CF, Rapaport MH, Pearce BD, Shah AJ, Vaccarino V. Diet, Stress and Mental Health. Nutrients. 2020 Aug 13;12(8):2428. doi: 10.3390/nu12082428.
PubMed 32823562Torheim LE, Ferguson EL, Penrose K, Arimond M. Women in resource-poor settings are at risk of inadequate intakes of multiple micronutrients. J Nutr. 2010 Nov;140(11):2051S-8S. doi: 10.3945/jn.110.123463. Epub 2010 Sep 29.
PubMed 20881075Chauhan A, Potdar J. Maternal Mental Health During Pregnancy: A Critical Review. Cureus. 2022 Oct 25;14(10):e30656. doi: 10.7759/cureus.30656. eCollection 2022 Oct.
PubMed 36426343Wang J, Liu X, Dong M, Sun X, Xiao J, Zeng W, Hu J, Li X, Guo L, Rong Z, He G, Sun J, Ning D, Chen D, Zhang Y, Zhang B, Ma W, Liu T. Associations of maternal ambient temperature exposures during pregnancy with the placental weight, volume and PFR: A birth cohort study in Guangzhou, China. Environ Int. 2020 Jun;139:105682. doi: 10.1016/j.envint.2020.105682. Epub 2020 Apr 2.
PubMed 32248024Ranciere F, Wafo O, Perrot X, Momas I. Associations between heat wave during pregnancy and term birth weight outcomes: The PARIS birth cohort. Environ Int. 2024 Jun;188:108730. doi: 10.1016/j.envint.2024.108730. Epub 2024 May 9.
PubMed 38776654
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indigenous Nutritional Supplements for Pregnancy to Improve Resilience in Environmental Heat
- ClinicalTrials.gov ID
- NCT07489664
- Acronym / sponsor ID
- INSPIRE / 10697-33069
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will use a quasi-experimental design to study if the effects of an indigenous heat-mitigating balanced dietary intervention on maternal health and neonatal development when implemented from preconception to delivery in a region with high temperatures.
The study will recruit 292 women of reproductive age who plan to become pregnant and assign them to either the intervention group or the comparison group in a 1:1 ratio. The intervention group will receive one customized indigenous heat-mitigating balanced diet as daily lunch meal (~1,000 kilocalories). The comparison group will continue their usual dietary practices while receive routine antenatal care and dietary counseling services according to national guidelines.
The intervention diet plans have been designed through review of dietary recommendations and published evidence, combined with community consultations to ensure feasibility and cultural acceptability. The food choices were established according to three criteria which required foods to have high nutrient content and be affordable and accessible within the local area. The meal composition includes whole grains, lentils, legumes, green leafy vegetables, dairy products, fermented foods, fish, and other culturally acceptable animal-source foods. A 14-day rotating menu will be implemented. The intervention will begin at least one month prior to conception and continue until delivery.
Meals will be prepared in kitchen in field site's office set up specially for meals preparation. Local chefs will be hired and counselled to prepare meals ensuring proper hygiene and following study's diet plans. Study data collectors will distribute meals to the participants. The team will use attendance records, intervention adherence forms, telephone follow-up and home visits to monitor intervention delivery. The team will organize home delivery services when they become essential.
The research team will evaluate maternal health at the end of each trimester starting from the time of conception until the end of pregnancy. Data will be collected through three different methods which include anthropometer, vitals assessments and testing blood samples for hemoglobin levels using point of care testing device (HemoCue 301+) and specific micronutrients \& inflammatory markers (Vitamin A, D, B9, B12, Zinc, Ferritin and CRP). The research team will collect stool samples to investigate gut microbiome composition through molecular techniques. The study will use weather stations, thermal drone cameras and wearable devices (FitBit) to measure heat exposure while linking those measurements to local weather patterns.
At delivery, neonatal anthropometric measurements will be obtained using standardized procedures. Study staff will collect cord blood samples which will then undergo biomarker analysis. Moreover, placental tissues will be collected for both gross examination and transcriptomic analysis.
For safety purposes, all individuals will be monitored carefully for food allergies by conducting regular assessments and establishing health facility connections to treat any medical complications. The study allows participants to join voluntarily while they maintain their right to leave at any moment without losing access to standard medical treatment.
The study has received ethical approval from the Aga Khan University Ethical Review Committee (Reference: 2024-10697-3239) and the National Bioethics Committee of Pakistan (Reference: 4-87/NBCR-1220/24-25/836). Written informed consent will be obtained prior to enrollment. Data will be managed in accordance with institutional confidentiality and data protection policies.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Indigenous Balanced Diet Arm | Other | Dietary Supplement: Indigenous Balanced Diet ArmParticipants 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. |
| Usual Diet Arm | No intervention | –Pregnant women in this arm will continue with their usual diet, and receives standard antenatal care. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indigenous Balanced Diet ArmThe 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. | Dietary supplement | Indigenous Balanced Diet Arm |
Primary outcome
Difference in proportion of neonates with low Weight-for-Gestational-Age Z-score (WGAZ< -2 SD) at birth between intervention and control arms.
Time frame: Within 24 hours of delivery
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
Difference in proportion of neonates with low height-for-Gestational-Age Z-score (LGAZ< -2 SD) at birth between intervention and control arms.
Time frame: Within 24 hours of delivery
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
13 secondary outcomes
Gestational age at delivery
Time frame: At delivery date
Mode of delivery
Time frame: At delivery
Maternal serum ferritin concentration
Time frame: 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
Time frame: 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
Time frame: Evaluated at the end of each trimester (within one week before or after the scheduled time point), from enrollment until delivery.
Generalized anxiety symptoms
Time frame: Evaluated at the end of each trimester (within one week before or after the scheduled time point), from enrollment until delivery.
Maternal gut microbiome alpha diversity
Time frame: Evaluated at the end of each trimester (within one week before or after the scheduled time point), from enrollment until delivery.
Placental gene expression levels
Time frame: At delivery
Estimated fetal weight during pregnancy
Time frame: Evaluated at the end of each trimester (within one week before or after the scheduled time point), from enrollment until delivery.
Perceived stress score
Time frame: Assessed at enrollment (baseline), monthly during pregnancy, and postpartum (after 2 weeks of delivery).
Postnatal depression symptoms
Time frame: Assessed at enrollment (baseline), monthly during pregnancy, and postpartum (after 2 weeks of delivery).
Depression symptoms
Time frame: Assessed at enrollment (baseline), monthly during pregnancy, and postpartum (after 2 weeks of delivery).
Combined Depression, Anxiety, and Stress score
Time frame: Assessed at enrollment (baseline), monthly during pregnancy, and postpartum (after 2 weeks of delivery).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Background: PubMed 39519557Gonzalez-Fernandez D, Muralidharan O, Neves PA, Bhutta ZA. Associations of Maternal Nutritional Status and Supplementation with Fetal, Newborn, and Infant Outcomes in Low-Income and Middle-Income Settings: An Overview of Reviews. Nutrients. 2024 Oct 31;16(21):3725. doi: 10.3390/nu16213725.
- Background: PubMed 27645498Unger HW, Ashorn P, Cates JE, Dewey KG, Rogerson SJ. Undernutrition and malaria in pregnancy - a dangerous dyad? BMC Med. 2016 Sep 19;14(1):142. doi: 10.1186/s12916-016-0695-2.
- Background: PubMed 39500369Lakhoo DP, Brink N, Radebe L, Craig MH, Pham MD, Haghighi MM, Wise A, Solarin I, Luchters S, Maimela G, Chersich MF; Heat-Health Study Group; HIGH Horizons Study Group. A systematic review and meta-analysis of heat exposure impacts on maternal, fetal and neonatal health. Nat Med. 2025 Feb;31(2):684-694. doi: 10.1038/s41591-024-03395-8. Epub 2024 Nov 5.
- Background: PubMed 12933733Taylor A. ABC of subfertility: extent of the problem. BMJ. 2003 Aug 23;327(7412):434-6. doi: 10.1136/bmj.327.7412.434. No abstract available.
- Background: PubMed 31487626Sheikh S, Qureshi RN, Raza F, Memon J, Ahmed I, Vidler M, Payne BA, Lee T, Sawchuck D, Magee L, von Dadelszen P, Bhutta Z; CLIP Working Group. Self-reported maternal morbidity: Results from the community level interventions for pre-eclampsia (CLIP) baseline survey in Sindh, Pakistan. Pregnancy Hypertens. 2019 Jul;17:113-120. doi: 10.1016/j.preghy.2019.05.016. Epub 2019 May 17.
- Background: PubMed 28758917Kuehn L, McCormick S. Heat Exposure and Maternal Health in the Face of Climate Change. Int J Environ Res Public Health. 2017 Jul 29;14(8):853. doi: 10.3390/ijerph14080853.
- Background: PubMed 36744021Shankar K, Ali SA, Ruebel ML, Jessani S, Borengasser SJ, Gilley SP, Jambal P, Yazza DN, Weaver N, Kemp JF, Westcott JL, Hendricks AE, Saleem S, Goldenberg RL, Hambidge KM, Krebs NF. Maternal nutritional status modifies heat-associated growth restriction in women with chronic malnutrition. PNAS Nexus. 2023 Jan 27;2(1):pgac309. doi: 10.1093/pnasnexus/pgac309. eCollection 2023 Jan.
- Background: PubMed 39200720Ramirez JD, Maldonado I, Mach KJ, Potter J, Balise RR, Santos H. Evaluating the Impact of Heat Stress on Placental Function: A Systematic Review. Int J Environ Res Public Health. 2024 Aug 22;21(8):1111. doi: 10.3390/ijerph21081111.
- Background: PubMed 38136639Grzeszczak K, Lanocha-Arendarczyk N, Malinowski W, Zietek P, Kosik-Bogacka D. Oxidative Stress in Pregnancy. Biomolecules. 2023 Dec 9;13(12):1768. doi: 10.3390/biom13121768.
- Background: PubMed 25222554Brett KE, Ferraro ZM, Yockell-Lelievre J, Gruslin A, Adamo KB. Maternal-fetal nutrient transport in pregnancy pathologies: the role of the placenta. Int J Mol Sci. 2014 Sep 12;15(9):16153-85. doi: 10.3390/ijms150916153.
- Background: PubMed 32823562Bremner JD, Moazzami K, Wittbrodt MT, Nye JA, Lima BB, Gillespie CF, Rapaport MH, Pearce BD, Shah AJ, Vaccarino V. Diet, Stress and Mental Health. Nutrients. 2020 Aug 13;12(8):2428. doi: 10.3390/nu12082428.
- Background: PubMed 20881075Torheim LE, Ferguson EL, Penrose K, Arimond M. Women in resource-poor settings are at risk of inadequate intakes of multiple micronutrients. J Nutr. 2010 Nov;140(11):2051S-8S. doi: 10.3945/jn.110.123463. Epub 2010 Sep 29.
- Trends in maternal mortality 2000 to 2020: estimates by WHO, UNICEF, UNFPA, World Bank Group and UNDESA/Population DivisionLink provided by the sponsor.
- Climate change impacts on healthLink provided by the sponsor.
- Climate Change Profile of PakistanLink provided by the sponsor.
- Key findings report of National Nutrition Survey of Pakistan 2018Link provided by the sponsor.
- Malnutrition in womenLink provided by the sponsor.
- Haemoglobin concentrations for the diagnosis of anaemia and assessment of severityLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be made available to anyone including other researchers. Participant confidentiality and privacy protection will be given utmost importance as even anonymized data could have potential indirect identifiers due to the particular locality of the study in a specific rural community, which may lead to the re-identification of participants and may damage the reputation of the community, or stigmatize the participants. Informed consent was also not obtained from the participants regarding sharing of personal data with the public. Thus, we will prioritize our ethical commitment by only making available results of the study in aggregated group format.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Junaid Iqbal, PhD principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indigenous Balanced Diet Arm in people with Heat Stress and Pregnancy, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junaid Iqbal, PhD (+923353189185, junaid.iqbal@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in proportion of neonates with low Weight-for-Gestational-Age Z-score (WGAZ< -2 SD) at birth between intervention and control arms. (time frame: Within 24 hours of delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07489664, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.