Picky Eaters, Feeding Interaction, Good Enough Parenting, Family Meals, Emotional Eating PreventionMI-FINCT03086811
"Improved Mother Infant Feeding Interaction (MI-FI) at 12 Months With Very Early Parent Training"
A study testing Mother Infant Feeding Interaction very early training in people with Picky Eaters, Feeding Interaction, Good Enough Parenting, Family Meals, Emotional Eating Prevention, run by Rambam Health Care Campus.
Trial 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… Read more about this study
- Who is it for?
- Ages 23 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Picky Eaters, Feeding Interaction, Good Enough Parenting, Family Meals, Emotional Eating Prevention
- What is being tested?
- Mother Infant Feeding Interaction very early training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- No sites listed yet
- Study dates
- 25 Oct 2011to 21 Jul 2013
- 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 23 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.)
About this study
Official title: "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.
Read the 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.
- Conditions
- Picky Eaters, Feeding Interaction, Good Enough Parenting, Family Meals, Emotional Eating Prevention
- Being tested
- Mother Infant Feeding Interaction very early training
- Keywords
- feeding interaction, infant eating habits, hunger satiety cues, childhood obesity
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mother Infant Feeding Interaction very early trainingBehavioural
weekly training meetings on 4 topics:
- What - proper nutrition and supplements for solid feeding phase (dietitian); What - the meaning of feeding to mother and infant (social worker).
- Who - feeding skills - knowledge and actual practices
- From anxiety to serenity - knowledge concerning growth patterns and common physical and emotional issues troubling parents of infants 4-12 months old.
- Prevention of obesity and emotional eating - practical advise and tips.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | 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 Receives: Behavioral: Mother Infant Feeding Interaction very early training |
| control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Chatoor feeding scale
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).
Measured: 12 months
Secondary outcomes (1)
eating habitts
Self reported questionnaires of Golan et al checking eating habits and obesogenic environment at home
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start25 Oct 2011
- Primary completion21 Jul 2013
- Study completion21 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Picky Eaters, Feeding Interaction, Good Enough Parenting, Family Meals, Emotional Eating PreventionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ron Shaoul, MD, Principal investigator, Pediatric Gastroenterology Unit, Ruth Rappaport Children's Hospital Rambam Health Care Campus, Haifa, Israel, Rappaport Faculty of Medicine;
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086811
- Sponsor's protocol ID
- 0156-11-RMB
- Acronym
- MI-FI
- Status last verified
- Jun 2017
- First submitted
- 16 Mar 2017
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
Redsell SA, Edmonds B, Swift JA, Siriwardena AN, Weng S, Nathan D, Glazebrook C. Systematic review of randomised controlled trials of interventions that aim to reduce the risk, either directly or indirectly, of overweight and obesity in infancy and early childhood. Matern Child Nutr. 2016 Jan;12(1):24-38. doi: 10.1111/mcn.12184. Epub 2015 Apr 20.
PubMed 25894857Bryant-Waugh R, Markham L, Kreipe RE, Walsh BT. Feeding and eating disorders in childhood. Int J Eat Disord. 2010 Mar;43(2):98-111. doi: 10.1002/eat.20795.
PubMed 20063374Meadows N. Assessment and management of feeding difficulties in infants. Community Pract. 2015 Feb;88(2):45-7. No abstract available.
PubMed 25720215Ammaniti M, Lucarelli L, Cimino S, D'Olimpio F, Chatoor I. Feeding disorders of infancy: a longitudinal study to middle childhood. Int J Eat Disord. 2012 Mar;45(2):272-80. doi: 10.1002/eat.20925. Epub 2011 Apr 14.
PubMed 21495054
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Improved Mother Infant Feeding Interaction (MI-FI) at 12 Months With Very Early Parent
- ClinicalTrials.gov ID
- NCT03086811
- Acronym / sponsor ID
- MI-FI / 0156-11-RMB
- Conditions
- Picky Eaters, Feeding Interaction, Good Enough Parenting, Family Meals, Emotional Eating Prevention
- Keywords
- feeding interaction, infant eating habits, hunger satiety cues, childhood obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 25 Oct 2011 (actual)
- Primary completion
- 21 Jul 2013 (actual)
- Study completion
- 21 Jul 2013 (actual)
- First posted
- 22 Mar 2017 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Mother Infant Feeding Interaction very early trainingFirst 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 |
| control group | No intervention | –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. |
Who may qualify
- Ages
- 23 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.)
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 |
|---|---|---|
| Mother Infant Feeding Interaction very early trainingweekly 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. | Behavioural | intervention group |
Primary outcome
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).
1 secondary outcome
eating habitts
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Background: PubMed 25894857Redsell SA, Edmonds B, Swift JA, Siriwardena AN, Weng S, Nathan D, Glazebrook C. Systematic review of randomised controlled trials of interventions that aim to reduce the risk, either directly or indirectly, of overweight and obesity in infancy and early childhood. Matern Child Nutr. 2016 Jan;12(1):24-38. doi: 10.1111/mcn.12184. Epub 2015 Apr 20.
- Background: PubMed 20063374Bryant-Waugh R, Markham L, Kreipe RE, Walsh BT. Feeding and eating disorders in childhood. Int J Eat Disord. 2010 Mar;43(2):98-111. doi: 10.1002/eat.20795.
- Background: PubMed 25720215Meadows N. Assessment and management of feeding difficulties in infants. Community Pract. 2015 Feb;88(2):45-7. No abstract available.
- Background: PubMed 21495054Ammaniti M, Lucarelli L, Cimino S, D'Olimpio F, Chatoor I. Feeding disorders of infancy: a longitudinal study to middle childhood. Int J Eat Disord. 2012 Mar;45(2):272-80. doi: 10.1002/eat.20925. Epub 2011 Apr 14.
- Individual participant dataSharing planned: Undecided. 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.
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.
Ron Shaoul, MD principal investigator
Pediatric Gastroenterology Unit, Ruth Rappaport Children's Hospital Rambam Health Care Campus, Haifa, Israel, Rappaport Faculty of Medicine;
Questions about this trial
What is this clinical trial studying?
A study testing Mother Infant Feeding Interaction very early training in people with Picky Eaters, Feeding Interaction, Good Enough Parenting, Family Meals, Emotional Eating Prevention, run by Rambam Health Care Campus.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 7 Jun 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chatoor feeding scale (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03086811, which also lists 4 linked publications.
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 7 Jun 2017.