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Effect of Nutrition Training on Mothers' Nutrition Pattern, Breast Milk and Newborn Intestinal Microbiota (microbiota)

Primary Purpose

Microbial Colonization, Nutrient Deficiency

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Nutrition Training
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Microbial Colonization focused on measuring microbiata, food groups

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Being literate,
  • Being within 48 hours after delivery,
  • No disease / complications in mother and newborn,
  • Delivery at term (according to the first day of the last menstrual period).

Exclusion Criteria:

• A mother's inability to breastfeed her baby for a variety of reasons, either short or long term (mastitis, abscess).

Sites / Locations

  • Inonu University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nutrition Group

Control Group

Arm Description

After the health status of the mothers in the experimental group was stabilized, approximately 20-30 minutes of nutritional education was given at the first interview before the hospital discharge. After nutrition education, motivational messages were sent to women's phones once a week. In addition, mothers were given nutritional counseling during their home visits during the 1st and 3rd months, and their questions and problems regarding nutrition were evaluated. The mother was supported where she needed it. In nutritional education, information was given such as adequate and balanced nutrition in the postpartum period, adequate fluid intake, consumption and importance of prebiotic and probiotic foods, the importance of healthy microbiota for infant health and the amount of nutrients equivalent to one serving. In addition, the handbook which contains the educational content is given to the mothers to facilitate the recall.

No intervention was made to the control group.

Outcomes

Primary Outcome Measures

Effect of nutrition traning
Food Consumption Frequency Registration Form It is a form created by determining the type, frequency and amount of food consumed in order to determine the food consumption habits of mothers in the last 1 month. Food Consumption Frequency Registration Form is composed of four basic food groups (Milk and dairy products,Meat and group foods, Vegetable and fruit group and Grain group). Mothers were asked to define the frequency of food consumption as daily, 5-6 times a week, 3-4 times a week, 1-2 times a week, once every 15 days and once a month. The mother of the amount of food they consume is used in everyday life, cups, spoons, were asked to specify the dimensions such as grain, followed by Turkey Ministry of Health Nutrition Guidelines (2016) was recorded by turning a portion.

Secondary Outcome Measures

Full Information

First Posted
January 8, 2020
Last Updated
January 8, 2020
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT04223375
Brief Title
Effect of Nutrition Training on Mothers' Nutrition Pattern, Breast Milk and Newborn Intestinal Microbiota
Acronym
microbiota
Official Title
Effect of Nutrition Training on Mother's Nutrition Pattern, Breast Milk and Newborn Intestinal Microbiota
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 22, 2018 (Actual)
Primary Completion Date
April 11, 2019 (Actual)
Study Completion Date
January 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

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

5. Study Description

Brief Summary
Objective: The aim of this study was to investigate the effects of nutrition Training on mothers' nutrition pattern, breast milk and newborn intestinal microbiota. Materials and methods: The study was conducted as a non-randomized controlled experimental study. The population of the study consisted of mothers and their babies who delivered vaginally, breastfeeded their babies at the end of the second postnatal day and delivered at the maternity ward of the Malatya Training and Research Hospital Beydağı Campus. The sample of the study consisted of 120 mothers, 57 of whom were experimental and 63 of them were in the control group. In this study, a sub-sample of 15 mothers and their infants was selected and microbiota of breast milk and stool samples were examined. In the first interview with the mothers in the experimental and control groups, Participant Identification Form, BTSKF were applied as a pre-test and stool samples of breast milk and newborn were taken. Then, the mothers in the experimental group were given nutritional education. In addition, motivational messages were sent to mothers' phones once a week. MTS in the experimental and control groups were filled with BTSKF as an intermediate test at the first month and post-test at the third month and stool samples of breast milk and newborn were collected at the mothers' own homes. During these visits, nutrition counseling was given to the mothers in the experimental group.
Detailed Description
Nutrition is very important from intrauterine life to old age for a healthy and productive life. However, the importance of pregnancy, childbirth and breastfeeding during the special stages in which the woman is experienced in her life process increases slightly (Ho et al., 2016; Erick, 2018; Tekiner and Ungan, 2014). Healthy nutrition is a key concern for the health of the baby during pregnancy, childbirth and breastfeeding periods as well as the health of the mother (Taşkın, 2016; Samur, 2008). Intrauterine life is transmitted by placental way and in the postpartum period, breast milk is fed to the baby. Therefore, in order to ensure optimal growth and development of the baby, the mother needs adequate, regular and quality nutrition (Ho et al., 2016; Erick, 2018; Tekiner and Ungan, 2014).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbial Colonization, Nutrient Deficiency
Keywords
microbiata, food groups

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Non-randomized controlled experimental study
Masking
Participant
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutrition Group
Arm Type
Experimental
Arm Description
After the health status of the mothers in the experimental group was stabilized, approximately 20-30 minutes of nutritional education was given at the first interview before the hospital discharge. After nutrition education, motivational messages were sent to women's phones once a week. In addition, mothers were given nutritional counseling during their home visits during the 1st and 3rd months, and their questions and problems regarding nutrition were evaluated. The mother was supported where she needed it. In nutritional education, information was given such as adequate and balanced nutrition in the postpartum period, adequate fluid intake, consumption and importance of prebiotic and probiotic foods, the importance of healthy microbiota for infant health and the amount of nutrients equivalent to one serving. In addition, the handbook which contains the educational content is given to the mothers to facilitate the recall.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention was made to the control group.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Training
Intervention Description
Postpartum women were educated on postpartum healthy and regular nutrition.
Primary Outcome Measure Information:
Title
Effect of nutrition traning
Description
Food Consumption Frequency Registration Form It is a form created by determining the type, frequency and amount of food consumed in order to determine the food consumption habits of mothers in the last 1 month. Food Consumption Frequency Registration Form is composed of four basic food groups (Milk and dairy products,Meat and group foods, Vegetable and fruit group and Grain group). Mothers were asked to define the frequency of food consumption as daily, 5-6 times a week, 3-4 times a week, 1-2 times a week, once every 15 days and once a month. The mother of the amount of food they consume is used in everyday life, cups, spoons, were asked to specify the dimensions such as grain, followed by Turkey Ministry of Health Nutrition Guidelines (2016) was recorded by turning a portion.
Time Frame
3 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being literate, Being within 48 hours after delivery, No disease / complications in mother and newborn, Delivery at term (according to the first day of the last menstrual period). Exclusion Criteria: • A mother's inability to breastfeed her baby for a variety of reasons, either short or long term (mastitis, abscess).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülçin NACAR, Msc
Organizational Affiliation
Inonu University
Official's Role
Study Director
Facility Information:
Facility Name
Inonu University
City
Malatya
State/Province
Battalgazi
ZIP/Postal Code
44280
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
30581784
Citation
Timur Tashan S, Ucar T, Aksoy Derya Y, Nacar G, Erci B. Validity and Reliability of the Turkish Version of the Modified Breast Cancer Worry Scale. Iran J Public Health. 2018 Nov;47(11):1681-1687.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/30581784
Description
Validity and Reliability of the Turkish Version of the Modified Breast Cancer Worry Scale.

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Effect of Nutrition Training on Mothers' Nutrition Pattern, Breast Milk and Newborn Intestinal Microbiota

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