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

December 28, 2018 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

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

Ages Eligible for Study

3 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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
Experimental: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increased Energy Regulation
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduce BMI
Time Frame: 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

Collaborators and Investigators

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

Sponsor

Nationwide Children's Hospital

Collaborators

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

Investigators

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

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

February 1, 2012

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

January 18, 2012

First Submitted That Met QC Criteria

January 23, 2012

First Posted (Estimate)

January 24, 2012

Study Record Updates

Last Update Posted (Actual)

January 2, 2019

Last Update Submitted That Met QC Criteria

December 28, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB11-00399
  • 1R03DK089198-01A1 (U.S. NIH Grant/Contract)

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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