- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05681208
Microbiota Awareness and Nutrition Education Given to Mothers With Motivational Interview
The Effect of Motivational Interview, Prepared According to the Health Behavior Interaction Model, on Microbiota Awareness and Attitudes on Infant Nutrition in Primiparous Mothers Who Start Complementary Nutrition: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yeşim Ceylantekin
- Phone Number: 905052423188
- Email: yesim.ceylantekin@afsu.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Mothers over the age of 18,
- Ability to read and write Turkish,
- Absence of any disease in the mother and child,
- The mother's willingness to participate in the research,
- Having a healthy, vaginal and mature delivery,
- Being a primiparous mother
- Feeding only with breast milk,
Exclusion Criteria:
Mothers not participating in at least one training,
- Mothers not participating in the motivational interview,
- Desire to leave the research
- Absence of ambivalent feelings
- Inability to create a food consumption frequency scheme
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
The training, which is prepared based on the motivational interview method, will be given individually, starting when baby is 4 months old, will be interviewed once a week for nine weeks.
In first meeting; before starting motivational interview, mothers were interviewed face-to-face with the Baby, Mother Introductory Information Form, Mothers', Babies' Food Consumption Frequency Registration Form, Microbiota Awareness Scale (MFI), Infant Nutrition Attitude Scale (LOWA), Behavior Change Stage Diagnostic Form, Motivational Interview rating the schedule will be applied.
At the end of this meeting, which lasts for 45-50 minutes, next meeting date will be determined, the meeting will be terminated.
Second interview is planned to last 60-90 minutes.
After the second meeting, Motivational interviews will provide information on nutritional posters, brochures of the Ministry of Health, complementary nutrition, nutrition for microbiota.
The scales to be used will be re-administered.
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Information will be given about the motivational interviews to be held and the objectives and content of the motivational interviews will be explained clearly. Care will be taken to ensure that the content of the brochures and materials provided is not too dense. It was prepared according to the Health Behavior Interaction Model of motivational interview steps. The first meeting of the motivational interview will start in the 4th month and the meetings will continue to be held every week for the first month and a half, and every two weeks for the next month and a half. Negotiations will end in nine weeks. After the last interview, the scales will be applied to the mother again. Motivational interviews are planned to last 60-90 minutes (first session 45-50 minutes) every week. |
No Intervention: Control group
Within the scope of the research, no intervention will be made to the mothers in the control group other than routine family health center practices.
In Turkey, 4-month-old baby follow-up continues at the Family Health Center, followed by midwives, nurses and doctors.
Scales will be applied to mothers by face-to-face interview method when they come for routine baby follow-up.
The training content given in the Family Health Center will be presented to the control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbiota awareness scale
Time Frame: before the 1st interview
|
-Microbiota awareness scale total score (The score range of the scale was defined as the lowest 18 points and the highest 100 points.
The cut-off score was not specified in the scale.
The high score obtained from the scale was evaluated as a high level of microbiota awareness.
The draft form of the scale was developed as a five-point Likert type (1=strongly disagree, 2=disagree, 3=undecided, 4=agree, 5=strongly agree) and includes 27 positive and 2 negative statements.
Two of the questions in the scale are knowledge questions with five options, marking the correct one was evaluated as 1 point and not marking the wrong one was evaluated as 1 point.
The last two questions consist of open-ended questions.
Those who do not answer these questions are given 1 point, one answer is 2 points, two answers are 3 points, three answers are 4 points, and those who answer four or more are 5 points.
|
before the 1st interview
|
Microbiota awareness scale
Time Frame: Last follow-up after 5th interview (1 month after first meeting)
|
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Last follow-up after 5th interview (1 month after first meeting)
|
Microbiota awareness scale
Time Frame: Last follow-up after 9th interview(1 month after the second interview)
|
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Last follow-up after 9th interview(1 month after the second interview)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Other Study ID Numbers
- AfyonkarahisarHSU-YC-1
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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