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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
The Effect of Functional Bread Dadih During Pregnancy and Health Outcomes

Conditions
-----------------
Birth Weight, Pregnancy Weight Gain

Intervention / Treatment
-----------------
* Other: Bread and vla dadiah
* Other: Bread and vla without dadiah


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Responden Intervention<br>Arm 1 (Interventional) : Respondent has given bread with composit flour and vla with dadiah. pregnant women received 1 pieces bread containing 50 gram provide total fat 4 gram, protein 5 gram, carbohydrate 23.8 gram, Fe 2 mg, 2150 kcal and vla dadiah containing 30 gram provide 308 kcal. | Other: Bread and vla dadiah<br>* Consumption bread and vla dadiah to pregnant women 1 Pieces a day during 12 weeks.<br>|
| Placebo Comparator: Responden Placebo<br>Arm 2 (Placebo) : Respondent has given bread with original flour (wheat flour) and vla original without dadiah. pregnant women received 1 pieces bread containing 50 gram and vla containing 30 gram. | Other: Bread and vla without dadiah<br>* Consumption bread and vla without dadiah to pregnant women 1 Pieces a day during 12 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight Pregnant Woman Measurement | Measuring Body Weight Pregnant Woman Baseline, 1St Measurement, 2nd Measurement, and 3rd Measurement (Weight in Kilograms) | 12 weeks | 
| Body Height Pregnant Woman Measurement | Measuring Body Height Pregnant Woman Baseline, 1St Measurement, 2nd Measurement, and 3rd Measurement (Height in Meters or Centimeters) | 12 weeks | 
| Body Mass Index Pregnant Woman Measurement | Measuring Body Height Pregnant Woman Baseline, 1St Measurement, 2nd Measurement, and 3rd Measurement (BMI in Kg/m^2) | 12 weeks | 
| Birth Weight of Infant Measurement | Measuring weight of infant (Weight in Grams) | 9 months | 
| Birth Length of Infant Measurement | Measuring Birth Length of infant (Length or height in Centimeters) | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristic of Woman Pregnancy | Description of Characteristic respondent are Mother's tribe, mother's education, mother's job, mother's knowledge, family income, age, and gestational weeks | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Functional Bread, Weight Increase, Infant Weight