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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ihuoma Eneli, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01515254
First received: January 18, 2012
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Children
Exogenous Obesity
Eating Behavior
Behavioral: lifestyle counseling, parental feeding

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Feeding Dynamic Intervention Study

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Increased Energy Regulation [ Time Frame: Change from baseline in energy compensation at 3 months and Change from baseline in energy compensation at 6 months ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 84
Study Start Date: February 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   3 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01515254

Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Ihuoma Eneli, MD, MS Nationwide Children's Hospital
  More Information

No publications provided

Responsible Party: Ihuoma Eneli, Medical Director, Center for Healthy Weight and Nutrition; Associate Professor of Pediatrics, The Ohio State University, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01515254     History of Changes
Other Study ID Numbers: IRB11-00399, 1R03DK089198-01A1
Study First Received: January 18, 2012
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Nationwide Children's Hospital:
Children
Obesity Prevention
Child Overweight
Eating Behavior
Energy Compensation
Food Intake
Parenting Behavior

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014