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

Primary Purpose

Birth Weight, Pregnancy Weight Gain

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Bread and vla dadiah
Bread and vla without dadiah
Sponsored by
Andalas University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Birth Weight focused on measuring Functional Bread, Weight Increase, Infant Weight

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Universitas Andalas

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Responden Intervention

Responden Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Body Weight Pregnant Woman Measurement
Measuring Body Weight Pregnant Woman Baseline, 1St Measurement, 2nd Measurement, and 3rd Measurement (Weight in Kilograms)
Body Height Pregnant Woman Measurement
Measuring Body Height Pregnant Woman Baseline, 1St Measurement, 2nd Measurement, and 3rd Measurement (Height in Meters or Centimeters)
Body Mass Index Pregnant Woman Measurement
Measuring Body Height Pregnant Woman Baseline, 1St Measurement, 2nd Measurement, and 3rd Measurement (BMI in Kg/m^2)
Birth Weight of Infant Measurement
Measuring weight of infant (Weight in Grams)
Birth Length of Infant Measurement
Measuring Birth Length of infant (Length or height in Centimeters)

Secondary Outcome Measures

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

Full Information

First Posted
January 3, 2023
Last Updated
February 4, 2023
Sponsor
Andalas University
Collaborators
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT05712629
Brief Title
The Effect of Functional Bread Dadih on Microbiota Profile of Weight Increase Pregnant Women and Infant Birth Weight
Official Title
The Effect of Functional Bread Dadih During Pregnancy and Health Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 12, 2022 (Actual)
Primary Completion Date
September 20, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Andalas University
Collaborators
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Birth Weight, Pregnancy Weight Gain
Keywords
Functional Bread, Weight Increase, Infant Weight

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Responden Intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Responden Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Bread and vla dadiah
Intervention Description
Consumption bread and vla dadiah to pregnant women 1 Pieces a day during 12 weeks.
Intervention Type
Other
Intervention Name(s)
Bread and vla without dadiah
Intervention Description
Consumption bread and vla without dadiah to pregnant women 1 Pieces a day during 12 weeks.
Primary Outcome Measure Information:
Title
Body Weight Pregnant Woman Measurement
Description
Measuring Body Weight Pregnant Woman Baseline, 1St Measurement, 2nd Measurement, and 3rd Measurement (Weight in Kilograms)
Time Frame
12 weeks
Title
Body Height Pregnant Woman Measurement
Description
Measuring Body Height Pregnant Woman Baseline, 1St Measurement, 2nd Measurement, and 3rd Measurement (Height in Meters or Centimeters)
Time Frame
12 weeks
Title
Body Mass Index Pregnant Woman Measurement
Description
Measuring Body Height Pregnant Woman Baseline, 1St Measurement, 2nd Measurement, and 3rd Measurement (BMI in Kg/m^2)
Time Frame
12 weeks
Title
Birth Weight of Infant Measurement
Description
Measuring weight of infant (Weight in Grams)
Time Frame
9 months
Title
Birth Length of Infant Measurement
Description
Measuring Birth Length of infant (Length or height in Centimeters)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Characteristic of Woman Pregnancy
Description
Description of Characteristic respondent are Mother's tribe, mother's education, mother's job, mother's knowledge, family income, age, and gestational weeks
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helmizar Helmizar, DR
Organizational Affiliation
Nutrition Department Faculty of Universitas Andalas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Azrimaidaliza Azrimaidaliza, DR
Organizational Affiliation
Department Nutrition Faculty of Universitas Andalas
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ferdinal Ferry, DR
Organizational Affiliation
Department Obstetry and Gynecology of Universitas Andalas
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Frima Elda, DR
Organizational Affiliation
Department Nutrition Faculty of Universitas Andalas
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Asrawati Asrawati, DR
Organizational Affiliation
Department Pediatric of Universitas Andalas
Official's Role
Study Director
Facility Information:
Facility Name
Universitas Andalas
City
Padang
State/Province
West Sumatera
ZIP/Postal Code
25127
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No
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https://pdfs.semanticscholar.org/7934/f3e473c8024109718faafa08c70569ed06e2.pdf
Description
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The Effect of Functional Bread Dadih on Microbiota Profile of Weight Increase Pregnant Women and Infant Birth Weight

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