The Feeding Dynamic Intervention: Self Regulation of Intake in Preschoolers

NCT01515254 | Completed DMC

• 2 other identifiers: IRB11-003991R03DK089198-01A1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Children; Exogenous Obesity; Eating Behavior

Keywords

Children; Obesity Prevention; Child Overweight; Energy Compensation; Eating Behavior; Food Intake; Parenting Behavior

Outcome Measures

Primary Outcomes (1)

• Increased Energy Regulation

  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 Outcomes (1)

• Reduce BMI

  Change from baseline in BMI-z score at 3 months and Change from baseline in BMI-z score at 6 months

Study Arms (2)

No intervention- control group

NO INTERVENTION

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

lifestyle counseling, parental feeding

EXPERIMENTAL

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

Interventions

lifestyle counseling, parental feeding BEHAVIORAL

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.

lifestyle counseling, parental feeding

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

• Eneli IU, Tylka TL, Hummel J, Watowicz RP, Perez SA, Kaciroti N, Lumeng JC. Rationale and design of the Feeding Dynamic Intervention (FDI) study for self-regulation of energy intake in preschoolers. Contemp Clin Trials. 2015 Mar;41:325-34. doi: 10.1016/j.cct.2015.01.006. Epub 2015 Jan 20.

  PMID: 25616192 BACKGROUND

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Ihuoma Eneli, MD, MS

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Center for Healthy Weight and Nutrition; Professor of Pediatrics, The Ohio State University

Study Record Dates

• First Submitted: January 18, 2012
• First Posted: January 24, 2012
• Study Start: February 1, 2012
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: January 2, 2019

Record last verified: 2018-12

Locations

US (1)