Indigenous Nutritional Supplements for Pregnancy to Improve Resilience in Environmental Heat
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 292
- 试验地点
- 1
- 主要终点
- Difference in proportion of neonates with low Weight-for-Gestational-Age Z-score (WGAZ< -2 SD) at birth between intervention and control arms.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Difference in proportion of neonates with low Weight-for-Gestational-Age Z-score (WGAZ< -2 SD) at birth between intervention and control arms.
时间窗: 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.
时间窗: 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
次要结局
- Mode of delivery(At delivery)
- Gestational age at delivery(At delivery date)
- 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.)
- Generalized anxiety symptoms(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(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(At delivery)
- Estimated fetal weight during pregnancy(Evaluated at the end of each trimester (within one week before or after the scheduled time point), from enrollment until delivery.)
- Perceived stress score(Assessed at enrollment (baseline), monthly during pregnancy, and postpartum (after 2 weeks of delivery).)
- Postnatal depression symptoms(Assessed at enrollment (baseline), monthly during pregnancy, and postpartum (after 2 weeks of delivery).)
- Depression symptoms(Assessed at enrollment (baseline), monthly during pregnancy, and postpartum (after 2 weeks of delivery).)
- Combined Depression, Anxiety, and Stress score(Assessed at enrollment (baseline), monthly during pregnancy, and postpartum (after 2 weeks of delivery).)
研究者
Junaid Iqbal
Assistant Professor (Research), Department of Paediatrics & Child Health.
Aga Khan University