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Completed

NCT Number: NCT05712629

The Effect of Functional Bread Dadih on Microbiota Profile of Weight Increase Pregnant Women and Infant Birth Weight

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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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Andalas

Padang, West Sumatera, 25127, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mothers with gestational 12 - 20 weeks
  • Health Conditions
  • Not moving home until delivery labour
  • Not suffering from syndrome metabolic diseases

Exclusion criteria

  • Not willing and signing an informed consent, and not willing to consume fungtional bread and dadih's vla or dadih sauce until delivery.
  • Abortus

Treatment and study plan

Bread and vla dadiah

Other

Consumption bread and vla dadiah to pregnant women 1 Pieces a day during 12 weeks.

Bread and vla without dadiah

Other

Consumption bread and vla without dadiah to pregnant women 1 Pieces a day during 12 weeks.

Primary outcomes

  1. Body Weight Pregnant Woman Measurement

    Time frame: 12 weeks

    Measuring Body Weight Pregnant Woman Baseline, 1St Measurement, 2nd Measurement, and 3rd Measurement (Weight in Kilograms)

  2. Body Height Pregnant Woman Measurement

    Time frame: 12 weeks

    Measuring Body Height Pregnant Woman Baseline, 1St Measurement, 2nd Measurement, and 3rd Measurement (Height in Meters or Centimeters)

  3. Body Mass Index Pregnant Woman Measurement

    Time frame: 12 weeks

    Measuring Body Height Pregnant Woman Baseline, 1St Measurement, 2nd Measurement, and 3rd Measurement (BMI in Kg/m^2)

  4. Birth Weight of Infant Measurement

    Time frame: 9 months

    Measuring weight of infant (Weight in Grams)

  5. Birth Length of Infant Measurement

    Time frame: 9 months

    Measuring Birth Length of infant (Length or height in Centimeters)

Secondary outcomes

  1. Characteristic of Woman Pregnancy

    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

Sponsors and collaborators

Lead sponsor

Andalas University

Other

Collaborators

  • National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

Registry information

Official study title

The Effect of Functional Bread Dadih During Pregnancy and Health Outcomes

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 3, 2023
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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