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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03086811
Recruitment Status : Completed
First Posted : March 22, 2017
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Picky Eaters, Feeding Interaction, Good Enough Parenting, Family Meals, Emotional Eating Prevention Behavioral: Mother Infant Feeding Interaction very early training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention group got 4 sequential weekly training meetings, in small workshop groups setting, by a highly experience pediatric dietitian and social worker. The program covered nutritional aspects, as well as feeding and parenting topics. Training took place when infants were 4-6 months old. Thereafter, internet-based support continued until infants reached 12 months. The control group received customary support via municipal mother-child health clinics. Mealtime interactions by videotaped home setting feeding were documented at 12-13 months.
Masking: Single (Outcomes Assessor)
Masking Description: Mealtime interactions by videotaped home setting feeding were evaluated using the Chatoor feeding scale by blinded to group viewers.
Primary Purpose: Prevention
Official Title: "Improved Mother Infant Feeding Interaction (MI-FI) at 12 Months With Very Early Parent
Actual Study Start Date : October 25, 2011
Actual Primary Completion Date : July 21, 2013
Actual Study Completion Date : July 21, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. eating habitts [ Time Frame: 12 months ]
    Self reported questionnaires of Golan et al checking eating habits and obesogenic environment at home



Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03086811


Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Ron Shaoul, MD Pediatric Gastroenterology Unit, Ruth Rappaport Children's Hospital Rambam Health Care Campus, Haifa, Israel, Rappaport Faculty of Medicine;
Publications:
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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03086811    
Other Study ID Numbers: 0156-11-RMB
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rambam Health Care Campus:
feeding interaction, infant eating habits, hunger satiety cues, childhood obesity