The Effect of Maternal Dadiah Supplementation During Pregnancy on Child Growth and Gastrointestinal Health Outcomes
Condition: Gastrointestinal Microbiome; Immunoglobulin A; Growth; Stunting, Nutritional
MeSH terms: Growth Disorders
Study type: Interventional

Summary: 
      The aim of our study is to assess the effect of giving dadiah as a supplement to pregnant
      women on improving the growth and digestive health of children.
    

Detailed description: 
      The study was carried out on pregnant women in four Public Health Center (PHC) areas in
      Padang Panjang, West Sumatra, Indonesia. They were screened for inclusion and exclusion
      criteria. Once eligibility was confirmed, pregnant women were randomly allocated to
      intervention or control groups. The details of the study protocol were explained, and
      voluntary written consent was obtained.

      General information about the mother was collected and a general physical examination was
      assessed. The intervention started at about 10-20 weeks of gestation and continued until just
      before the time of delivery. Subjects took the study supplements concurrently with the
      government's dietary supplementation program. In each home visit, the remaining supplements
      from the previous visit were counted and documented in the pudding checklist form. Details of
      symptoms or illnesses during consumption of dadiah pudding will be reported either by
      participants directly contacting field officers, study staff, or during weekly visits and
      will be recorded and documented in the case report form. In the third trimester, subjects
      received healthy food, breastfeeding practices, and child development education to support
      mothers in maintaining their nutritional status, preparing exclusive breastfeeding, and
      optimizing child development.

      Healthy babies born to mothers will be the focus of this study and followed up until the age
      of three months to assess their growth. The information includes the baby's health history
      after birth, anthropometric measurements, nutritional intake, and breastfeeding practices
      which are measured repeatedly in the first, second, and third months. The collection of
      breast milk and baby feces is carried out in the first week and third month after the baby is
      born.

      The sample size was calculated taking into account all outcome variables including the
      proportion of gut microbiota, levels of IgA secretion in breast milk and infant feces, and
      child growth, with the independent variable being maternal supplementation during pregnancy.

      Data quality assurance is carried out through training starting from the period of data
      collection and supervision during and after data collection, including the data analysis
      process. This included training for enumerators, subjects and using a validated questionnaire
      for a group of subjects representing similar characteristics for this study. Data input and
      cleaning process will use excel and SPSS while for food intake data using NutriSurvey 2007.
      Data entry will be carried out by data collection officers after data collection. The data
      cleaning process includes removing outliers and regrouping multiple results that have similar
      meanings. The data will be interpreted as mean ± standard deviation if the data is normally
      distributed and the median (min-max) if the data is not normally distributed. Statistical
      analysis using SPSS 20 and data will be analyzed using univariate and bivariate analysis.
      Univariate analysis is used to describe characteristics and socio-demographics, medical
      history, pregnancy, and obstetric profiles of pregnant women. Numerical variables between
      groups will be analyzed using an Independent sample t-test if the data has normal
      distribution or the Mann Whitney test if the data distribution is not normal. Categorical
      variables between groups will be analyzed using Chi-square or Fisher test. Differences
      between birth and 3 months old follow up will be analyzed using Dependent t-tests if the data
      distribution has normal distribution or Wilcoxon test if the data distribution is not normal.
    

Intervention name(s): Dadiah Pudding; Pudding without Dadiah
Intervention type(s): Other; Other
Intervention description(s): Supplementation of Dadiah Pudding to pregnant women. One cup a day for 18-26 weeks of pregnancy; Supplementation of Milk Pudding without dadiah to pregnant women. One cup a day for 18-26 weeks of pregnancy
Other intervention name(s): Minangkabau Yogurt Pudding; Milk Pudding
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomly assigned to two groups; the intervention group that received dadiah pudding and the control group that received pudding without dadiah in parallel for the duration of the study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: dadiah; local yogurt; Minangkabau yogurt; pregnant women; dietary supplement; gut microbiota; immunoglobulin A; gastrointestinal health; fermented dairy product; lactic acid bacteria; child growth; probiotic