NCT04223375

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 10, 2020

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

January 8, 2020

Last Update Submit

January 8, 2020

Conditions

Keywords

microbiatafood groups

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Nutrition Group

EXPERIMENTAL

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.

Behavioral: Nutrition Training

Control Group

NO INTERVENTION

No intervention was made to the control group.

Interventions

Postpartum women were educated on postpartum healthy and regular nutrition.

Nutrition Group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, Battalgazi, 44280, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 30581784BACKGROUND

Related Links

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gülçin NACAR, Msc

    Inonu University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Non-randomized controlled experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Effect of Nutrition Training on Mothers' Nutrition Pattern, Breast Milk and Newborn Intestinal Microbiota

Study Record Dates

First Submitted

January 8, 2020

First Posted

January 10, 2020

Study Start

October 22, 2018

Primary Completion

April 11, 2019

Study Completion

January 6, 2020

Last Updated

January 10, 2020

Record last verified: 2020-01

Locations