- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03086811
"Improved Mother Infant Feeding Interaction (MI-FI) at 12 Months With Very Early Parent Training" (MI-FI)
5 juni 2017 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
166
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
23 år till 35 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Beskrivning
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.)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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
|
weekly training meetings on 4 topics:
|
Inget ingripande: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Chatoor feeding scale
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
eating habitts
Tidsram: 12 months
|
Self reported questionnaires of Golan et al checking eating habits and obesogenic environment at home
|
12 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Ron Shaoul, MD, Pediatric Gastroenterology Unit, Ruth Rappaport Children's Hospital Rambam Health Care Campus, Haifa, Israel, Rappaport Faculty of Medicine;
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- Ammaniti 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.
- Bryant-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.
- Meadows N. Assessment and management of feeding difficulties in infants. Community Pract. 2015 Feb;88(2):45-7. No abstract available.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
25 oktober 2011
Primärt slutförande (Faktisk)
21 juli 2013
Avslutad studie (Faktisk)
21 juli 2013
Studieregistreringsdatum
Först inskickad
16 mars 2017
Först inskickad som uppfyllde QC-kriterierna
16 mars 2017
Första postat (Faktisk)
22 mars 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
7 juni 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 juni 2017
Senast verifierad
1 juni 2017
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 0156-11-RMB
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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