Universitas Andalas
Padang, West Sumatera, 25127, Indonesia
NCT Number: NCT05712629
The aims of study to determine the effect of giving functional bread and dadih's vla on weight gain of pregnant women and birth weight of babies.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Padang, West Sumatera, 25127, Indonesia
Dadih contains BAL 108 CFU/ml which is probiotic. Consumption of functional bread and dadih's vla during pregnancy can improve the composition of the gut microbiota so that it can increase maternal weight and provide adequate nutrition during pregnancy. Good nutrient absorption can support good nutritional status and weight in babies who are born. This study aims to determine the effect of giving functional bread and dadih's vla on weight gain of pregnant women and birth weight of babies.
This study used a randomized controlled trial (RCT) design with a population of all pregnant women in the Kuranji, Nanggalo and Andalas Health Centers. The sample consisted of 88 people and was divided into two groups, namely the intervention group and the control group. Each amounted to 44 samples. The sample selection used the double-blind method and randomized controlled trial (RCT) research design. The intervention started at about 12-20 weeks of gestation and continued until just before the time of delivery. 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.
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 25 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 independent t-tests if the data distribution has normal distribution or Mann Whitney test if the data distribution is not normal.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Consumption bread and vla dadiah to pregnant women 1 Pieces a day during 12 weeks.
Consumption bread and vla without dadiah to pregnant women 1 Pieces a day during 12 weeks.
Time frame: 12 weeks
Measuring Body Weight Pregnant Woman Baseline, 1St Measurement, 2nd Measurement, and 3rd Measurement (Weight in Kilograms)
Time frame: 12 weeks
Measuring Body Height Pregnant Woman Baseline, 1St Measurement, 2nd Measurement, and 3rd Measurement (Height in Meters or Centimeters)
Time frame: 12 weeks
Measuring Body Height Pregnant Woman Baseline, 1St Measurement, 2nd Measurement, and 3rd Measurement (BMI in Kg/m^2)
Time frame: 9 months
Measuring weight of infant (Weight in Grams)
Time frame: 9 months
Measuring Birth Length of infant (Length or height in Centimeters)
Time frame: 4 weeks
Description of Characteristic respondent are Mother's tribe, mother's education, mother's job, mother's knowledge, family income, age, and gestational weeks
Andalas University
Other
The Effect of Functional Bread Dadih During Pregnancy and Health Outcomes
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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