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

February 4, 2023 updated by: Dr. Helmizar, SKM, M.Biomed, Andalas University

The Effect of Functional Bread Dadih During Pregnancy and Health Outcomes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • West Sumatera
      • Padang, West Sumatera, Indonesia, 25127
        • Universitas Andalas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Responden Intervention
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
Consumption bread and vla dadiah to pregnant women 1 Pieces a day during 12 weeks.
PLACEBO_COMPARATOR: Responden Placebo
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
Consumption bread and vla without dadiah to pregnant women 1 Pieces a day during 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 weeks
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)
12 weeks
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)
12 weeks
Birth Weight of Infant Measurement
Time Frame: 9 months
Measuring weight of infant (Weight in Grams)
9 months
Birth Length of Infant Measurement
Time Frame: 9 months
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
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
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andalas University

Collaborators

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

Investigators

  • Principal Investigator: Helmizar Helmizar, DR, Nutrition Department Faculty of Universitas Andalas
  • Study Director: Azrimaidaliza Azrimaidaliza, DR, Department Nutrition Faculty of Universitas Andalas
  • Study Director: Ferdinal Ferry, DR, Department Obstetry and Gynecology of Universitas Andalas
  • Study Director: Frima Elda, DR, Department Nutrition Faculty of Universitas Andalas
  • Study Director: Asrawati Asrawati, DR, Department Pediatric of Universitas Andalas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 12, 2022

Primary Completion (ACTUAL)

September 20, 2022

Study Completion (ACTUAL)

December 20, 2022

Study Registration Dates

First Submitted

January 3, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (ACTUAL)

February 3, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 4, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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