NCT05681208

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

January 25, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

January 12, 2023

Status Verified

December 1, 2022

Enrollment Period

11 months

First QC Date

December 15, 2022

Last Update Submit

December 26, 2022

Conditions

Keywords

microbiotamotivational interviewhealth behavior interaction model

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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)

  • 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)

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: Motivational interview

Control group

NO INTERVENTION

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.

Interventions

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.

Intervention group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMothers over 18
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

December 15, 2022

First Posted

January 12, 2023

Study Start

January 25, 2023

Primary Completion

December 15, 2023

Study Completion

December 15, 2024

Last Updated

January 12, 2023

Record last verified: 2022-12