MicrobiotaNCT05681208
Microbiota Awareness and Nutrition Education Given to Mothers With Motivational Interview
A study testing Motivational interview in people with Microbiota, run by Afyonkarahisar Health Sciences University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microbiota
- What is being tested?
- Motivational interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2023to 15 Dec 2024
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- Microbiota
- Being tested
- Motivational interview
- Keywords
- microbiota, motivational interview, health behavior interaction model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: Last follow-up after 9th interview(1 month after the second interview)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start25 Jan 2023 (estimated)
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrobiotaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeşim Ceylantekin, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681208
- Sponsor's protocol ID
- AfyonkarahisarHSU-YC-1
- Status last verified
- Dec 2022
- First submitted
- 15 Dec 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05681208
- Acronym / sponsor ID
- AfyonkarahisarHSU-YC-1
- Conditions
- Microbiota
- Keywords
- microbiota, motivational interview, health behavior interaction model
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 25 Jan 2023 (estimated)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 12 Jan 2023 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Motivational interviewThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Motivational interviewInformation 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. | Behavioural | Intervention group |
Primary outcome
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.
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interview in people with Microbiota, run by Afyonkarahisar Health Sciences University.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yeşim Ceylantekin (905052423188, yesim.ceylantekin@afsu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota awareness scale (time frame: before the 1st interview). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2023.