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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04223375
Other study ID # Turgut Özal
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 22, 2018
Est. completion date January 6, 2020

Study information

Verified date January 2020
Source Inonu University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date January 6, 2020
Est. primary completion date April 11, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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).

Study Design


Intervention

Behavioral:
Nutrition Training
Postpartum women were educated on postpartum healthy and regular nutrition.

Locations

Country Name City State
Turkey Inonu University Malatya Battalgazi

Sponsors (1)

Lead Sponsor Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Timur Tashan S, Uçar 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
3 months
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