Microbiota Awareness and Nutrition Education Given to Mothers With Motivational Interview

Microbiota Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05681208
• Other study ID #: AfyonkarahisarHSU-YC-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 25, 2023
• Est. completion date: December 15, 2024

Study information

• Verified date: December 2022
• Source: Afyonkarahisar Health Sciences University
• Contact: Yesim Ceylantekin
• Phone: 905052423188
• Email: yesim.ceylantekin[@]afsu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: December 15, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Microbiota

Intervention

Behavioral:
• Motivational interview
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Afyonkarahisar Health Sciences University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiota awareness scale	-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
Primary	Microbiota awareness scale	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)
Primary	Microbiota awareness scale	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)