"Improved Mother Infant Feeding Interaction (MI-FI) at 12 Months With Very Early Parent Training" (MI-FI)

June 5, 2017 updated by: Rambam Health Care Campus

"Improved Mother Infant Feeding Interaction (MI-FI) at 12 Months With Very Early Parent

Rise in childhood obesity and poor eating habits and eating problems is apparent over the last decades. Parents are at lose what the correct way to tackle these problems may be. This study examined whether professional behavioral and nutritional training of first time mothers improves feeding relationship and infants eating habits at 12 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

From 166 first time mother-infant recruited, 128 completed the trail. Intervention group, mother-infant dyads got a month long weekly based training in small workshop groups about nutrition, feeding and parenting when infants were 4-6 months old. training was given by a highly experience pediatric dietitian and social worker. Thereafter, internet-based support continued until infants reached 12 months. The control group received customary support via municipal mother-child health clinics. Mealtime interactions were videotaped at home setting at 12 months and were evaluated using the Chatoor feeding scale by blinded (to group) viewers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
166

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

23 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • normal and healthy pregnancy
  • full term delivery of infants
  • infants with a normal birth weight and no health problems
  • Mothers recruited had at least a high school education
  • mothers lived near to or in the city (important for video taping)

Exclusion Criteria:

  • Mothers with mental illness in the present or the past (such as schizophrenia, depression or an eating disorder)
  • infants with chronic diseases that required specific diets (such as milk allergy) or gastrointestinal diseases (celiac disease, type 1 diabetes, Crohn's disease etc.)

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: intervention group
First time mothers, when infants were ages 4-6 months old, took part in a training program in small group setting (10-12 mother-infants). the program continued for a month, with 4 weekly meetings. group coordinators were a highly experienced pediatric dietitian, and a social worker. Training topics addressed were infant healthy nutrition and growth, feeding skills, obesity and emotional feeding prevention, parenting. Thereafter, mothers were encouraged to stay in contact with the trainers, till infants reached age 12 months and data was collected using video taping of mealtime feeding interactions at home setting environment. Mother Infant Feeding Interaction very early training
Behavioral: Mother Infant Feeding Interaction very early training

weekly training meetings on 4 topics:

  1. What - proper nutrition and supplements for solid feeding phase (dietitian); What - the meaning of feeding to mother and infant (social worker).
  2. Who - feeding skills - knowledge and actual practices
  3. From anxiety to serenity - knowledge concerning growth patterns and common physical and emotional issues troubling parents of infants 4-12 months old.
  4. Prevention of obesity and emotional eating - practical advise and tips.
No Intervention: control group
Control group first time mothers were recruited when infants were around 11-12 months of age for data collection of mealtime feeding interactions taping at home setting environment. They received during this year the official support and training given in municipality care centers.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Chatoor feeding scale
Time Frame: 12 months
the Chatoor observational scale for Mother-Infant interaction during feeding was purchased from the Chatoor Center. The Scale consists of 46 mother and infant behavior modes which are rated throughout the feeding session. Five subscale scores are derived: 1) Dyadic Reciprocity, 2) Dyadic Conflict, 3) Talk and Distraction, 4) Struggle for Control, and 5) Maternal Non-Contingency. The CFS has been demonstrated to discriminate between infants with and without feeding disorders and can be used with infants and toddlers ranging from 1 month to 3 years of age (Chatoor et al, 1997).
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
eating habitts
Time Frame: 12 months
Self reported questionnaires of Golan et al checking eating habits and obesogenic environment at home
12 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rambam Health Care Campus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ron Shaoul, MD, Pediatric Gastroenterology Unit, Ruth Rappaport Children's Hospital Rambam Health Care Campus, Haifa, Israel, Rappaport Faculty of Medicine;

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 21, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 21, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0156-11-RMB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The investigators plan to publish results of the research project in peer reviewed journals. However, individual data collected, such as video taping of family meals will not be shared.

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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