Microbial ColonizationmicrobiotaNCT04223375
Effect of Nutrition Training on Mothers' Nutrition Pattern, Breast Milk and Newborn Intestinal Microbiota
A study testing Nutrition Training in people with Microbial Colonization and Nutrient Deficiency, run by Inonu University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization, Nutrient Deficiency
- What is being tested?
- Nutrition Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2018to 6 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- A mother's inability to breastfeed her baby for a variety of reasons, either short or long term (mastitis, abscess).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Microbial Colonization, Nutrient Deficiency
- Being tested
- Nutrition Training
- Keywords
- microbiata, food groups
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition TrainingBehavioural
Postpartum women were educated on postpartum healthy and regular nutrition.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Nutrition Training |
| Control Group | No intervention | No intervention was made to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start22 Oct 2018
- Primary completion11 Apr 2019
- Study completion6 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Non-randomized controlled experimental study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gnacar, Inonu University
- Investigators
- Gülçin NACAR, Msc, Study director, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223375
- Sponsor's protocol ID
- Turgut Özal
- Acronym
- microbiota
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2020
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30581784
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nutrition Training on Mother's Nutrition Pattern, Breast Milk and Newborn Intestinal Microbiota
- ClinicalTrials.gov ID
- NCT04223375
- Acronym / sponsor ID
- microbiota / Turgut Özal
- Conditions
- Microbial Colonization, Nutrient Deficiency
- Keywords
- microbiata, food groups
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 6 Jan 2020 (actual)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Non-randomized controlled experimental study
| Arm | Type | Receives |
|---|---|---|
| Nutrition Group | Experimental | Behavioral: Nutrition TrainingAfter 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. |
| Control Group | No intervention | –No intervention was made to the control group. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- A mother's inability to breastfeed her baby for a variety of reasons, either short or long term (mastitis, abscess).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition TrainingPostpartum women were educated on postpartum healthy and regular nutrition. | Behavioural | Nutrition Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Background: PubMed 30581784Timur 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.
- Validity and Reliability of the Turkish Version of the Modified Breast Cancer Worry Scale.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülçin NACAR, Msc study director
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Training in people with Microbial Colonization and Nutrient Deficiency, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of nutrition traning (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04223375, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2020.