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The Feeding Dynamic Intervention: Self Regulation of Intake in Preschoolers (FeeDIn)

28 december 2018 bijgewerkt door: Ihuoma Eneli, Nationwide Children's Hospital

The Feeding Dynamic Intervention Study

In this study the investigators will examine the Feeding Dynamic Intervention (FDI) as a tool to prevent obesity in young children. The purpose of the intervention is to improving caregiver feeding practices, child eating behaviors, and child self-regulation of energy intake in the short term.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Childhood obesity is a significant public health problem. In the last three decade, there has been a marked increase in the prevalence of childhood obesity. Currently, 23% of preschoolers (2-5 years) in the United States are overweight or obese, a critical period to target in hopes of reversing this trend. The purpose of this study is to test the efficacy of a novel obesity intervention program for preschool-aged children. Emerging consensus indicates that excessive, intrusive, overt control in feeding or a chaotic non-structured feeding environment are risk factors for childhood obesity. The 2007 Expert Committee Recommendations on the Prevention, Assessment, and Treatment of Childhood Obesity specifically identified maternal feeding practices as important, categorically stating there is consistent evidence to support "avoiding overly restrictive feeding behaviors." The guidelines emerged from a growing body of literature indicating that overly controlling caregiver feeding behaviors, in particular, significantly increase children's obesity risk.

Despite the evidence for the importance of feeding dynamics, no childhood obesity interventions focused on this area have been rigorously tested. The Feeding Dynamic Intervention (FDI) is a 12-week educational intervention. The intervention will be delivered in a closed group setting and will consist of 6 intervention sessions lasting 90 minutes each. We will recruit 84 mothers with 3- to 5-year-old obese children, randomly assigned to either the FDI or a comparison to a waiting list control group (WLG). At the end of the 6 month study we will assess knowledge and behavioral changes between the groups on (i) maternal self-reported feeding practices; (ii) improving energy compensation (COMPX), decreasing Eating in the Absence of Hunger (EAH) and increasing mother-reported satiety responsiveness in their child. Finally, we will investigate an exploratory hypothesis that children in the FDI group, compared to children in the wait-list control group, will demonstrate a lower increase in body mass index (BMI) z-score over 6 months.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

70

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Ohio
      • Columbus, Ohio, Verenigde Staten, 43205
        • Nationwide Children's Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

3 jaar tot 5 jaar (Kind)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • The child is between ages 3-5 years (36 to 71 months). [Note if a family has more than one qualifying child we will choose the child with the lower CEBQ SR score and if they are equal we will randomly select the target child for the study dyad.]
  • Child's body mass index > 85th percentile for age and sex
  • This will be calculated based on age, weight and height using the Center for Healthy Weight and Nutrition BMI calculator [if mother is unsure of the weight and height ask whether she has been told her child is overweight or obese by the PCP]
  • Child has significantly abnormal parent-reported impairment of energy regulation (Rating of 2.8 or lower on the CEB-Q).
  • The mother is fluent in English (measures are limited to English at this time)
  • Mother (or female caregiver) has primary legal and physical custody of the child and is primarily responsible for feeding the child. Specifically the child is not in a non-parental home daycare more than 20 hours/week. Structured child care centers are not included in this limitation because they use structure care and feeding techniques similar to those taught in the FeeDIn Program.

Exclusion Criteria:

  • Child has a medical condition or takes a medication that affects appetite, eating, or growth;
  • Child has food allergies or dietary restrictions that interfere with feeding or the study tests (i.e., milk, gluten and eggs?)
  • Child has any developmental or behavioral diagnosis that might affect his/her ability to respond to a behaviorally-based intervention, e.g., cognitive impairment, language delay, or autism.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: No intervention- control group
Visits to physicians, WIC offices, nutrition program etc will be tracked. The subjects will undergo the energy regulation tests at baseline and 3 months. They will complete surveys and have their weight taken. The control group subjects will have the opportunity to receive the intervention at the end of the study
Experimenteel: lifestyle counseling, parental feeding
Intervention group subjects will undergo a Feeding Dynamic Intervention (FDI). The intervention will be delivered in a closed group setting and will consist of 6 intervention sessions lasting 90 minutes each. Visits to physicians, WIC offices, nutrition program etc will be tracked. The subjects will undergo the energy regulation tests at baseline and 3 months. They will complete surveys and have their weight taken.
Gedragsmatig: lifestyle counseling, parental feeding
Intervention group subjects will undergo a Feeding Dynamic Intervention (FDI). The intervention will be delivered in a closed group setting and will consist of 6 intervention sessions lasting 90 minutes each. Visits to physicians, WIC offices, nutrition program etc will be tracked. The subjects will undergo the energy regulation tests at baseline and 3 months. They will complete surveys and have their weight taken.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Increased Energy Regulation
Tijdsspanne: Change from baseline in energy compensation at 3 months and Change from baseline in energy compensation at 6 months
Children in the FDI group, compared to children in the wait-list control group will show improved energy compensation regulation (COMPX), decreased Eating in the Absence of Hunger (EAH), and increasing Satiety Responsiveness (CEBQ-SR).
Change from baseline in energy compensation at 3 months and Change from baseline in energy compensation at 6 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Reduce BMI
Tijdsspanne: Change from baseline in BMI-z score at 3 months and Change from baseline in BMI-z score at 6 months
Children in the FDI group, compared to children in the wait-list control group, will demonstrate a lower increase in body mass index (BMI) z-score over 6 months.
Change from baseline in BMI-z score at 3 months and Change from baseline in BMI-z score at 6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Nationwide Children's Hospital

Medewerkers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Onderzoekers

  • Hoofdonderzoeker: Ihuoma Eneli, MD, MS, Nationwide Children's Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2012

Primaire voltooiing (Werkelijk)

1 juni 2018

Studie voltooiing (Werkelijk)

1 juli 2018

Studieregistratiedata

Eerst ingediend

18 januari 2012

Eerst ingediend dat voldeed aan de QC-criteria

23 januari 2012

Eerst geplaatst (Schatting)

24 januari 2012

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 januari 2019

Laatste update ingediend die voldeed aan QC-criteria

28 december 2018

Laatst geverifieerd

1 december 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB11-00399
  • 1R03DK089198-01A1 (Subsidie/contract van de Amerikaanse NIH)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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