- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04223375
Effect of Nutrition Training on Mothers' Nutrition Pattern, Breast Milk and Newborn Intestinal Microbiota (microbiota)
Effect of Nutrition Training on Mother's Nutrition Pattern, Breast Milk and Newborn Intestinal Microbiota
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Battalgazi
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Malatya, Battalgazi, Turkey, 44280
- Inonu University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nutrition Group
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. |
Postpartum women were educated on postpartum healthy and regular nutrition.
|
|
No Intervention: Control Group
No intervention was made to the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of nutrition traning
Time Frame: 3 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gülçin NACAR, Msc, Inonu University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Turgut Özal
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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