Microbiota Awareness and Nutrition Education Given to Mothers With Motivational Interview

December 26, 2022 updated by: Yeşim Ceylantekin, Afyonkarahisar Health Sciences University

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

Complementary nutrition is considered a critical step not only for changes in nutritional requirements but also for the formation of life-long taste preferences, nutrition and eating habits that may affect health in the long run. While the microbiota is developing, in the early stages of life, the wrong food choice negatively affects the microbiota development and causes malnutrition. In this study, the effect of motivational interviews prepared according to the Health Behavior Interaction Model on microbiota awareness and infant feeding attitude will be investigated in primiparous mothers who will start complementary feeding.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.

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.

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)
  • 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.)
  • General information sub-dimension score level
  • Product information sub-dimension score level
  • Chronic disease sub-dimension score level
  • Probiotic and prebiotic sub-dimension score level
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)
  • 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).
  • General information sub-dimension score level
  • Product information sub-dimension score level
  • Chronic disease sub-dimension score level
  • Probiotic and prebiotic sub-dimension score level
Last follow-up after 9th interview(1 month after the second interview)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 25, 2023

Primary Completion (Anticipated)

December 15, 2023

Study Completion (Anticipated)

December 15, 2024

Study Registration Dates

First Submitted

December 15, 2022

First Submitted That Met QC Criteria

December 26, 2022

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

December 26, 2022

Last Verified

December 1, 2022

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

No

Studies a U.S. FDA-regulated device product

No

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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