Early Childhood Obesity Prevention Program

NCT02052518 | Completed DMC

• 1 other identifier: HD073966-02
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This study is proposed on behalf of the Hartford Childhood Wellness Alliance, a 107 member, 35 group organization whose goal is to improve the health of children in Hartford, CT. In a randomized control trial, the primary aim of this study is to test the initial efficacy of a program of enhanced home visitation with neighborhood and community support to change maternal behaviors related to infant nutrition (sweetened beverage/juice consumption, breastfeeding and introduction of solids), parenting skills (establishing routines around sleep, reading cues for hunger, satiety, television time) and family wellness (improving the home food environment, enhancing physical activity). The investigators hypothesize that at 12 months of age, infants in the intervention arm will drink less sugar sweetened beverages/juices, will have ingested solids at an older age, will have been breastfed longer and more exclusively than infants in the control arm and will have less TV viewing, more established sleep routines and greater soothability (primary outcomes).

Conditions

Body Weight Changes

Keywords

Childhood obesity; Breastfeeding; Introduction of solids; Introduction of juice

Outcome Measures

Primary Outcomes (1)

• Number of months of breast feeding

  Number of months that child is breastfed

  6 and 12 months

Study Arms (2)

Enhanced NFN Home Program

EXPERIMENTAL

Education and Skill set training with materials to implement the behaviors recommended. Using a motivational interviewing framework, intervention participants will receive dietary and activity counseling, develop a Family Wellness Plan and will be linked to community resources.

Behavioral: Experimental

Nurturing Family Network Home Visitation

PLACEBO COMPARATOR

Mothers will receive the standard of care from the Nurturing Families Network Home Visitation program

Behavioral: Experimental

Interventions

Experimental BEHAVIORAL

These participants will receive the enhanced intervention including decision support and problem solving skills in addition to the standard of care for the individuals in the Nuturing Family Network Home Visition Program

Also known as: Enhanced NFN Home Program

Enhanced NFN Home Program; Nurturing Family Network Home Visitation

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Enrolled in the Nurturing Families Network Program
• Singleton birth \>34 weeks gestation
• Any race or ethnicity
• ECHO neighborhood
• Mothers and their newborns

You may not qualify if:

• Mothers or newborns with special health care needs
• Infant with major malformation
• Small for Gestational Age/low birth weight

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead
• University of Connecticut: collaborator
• UConn Health: collaborator

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Related Publications (1)

• Cloutier MM, Wiley J, Wang Z, Grant A, Gorin AA. The Early Childhood Obesity Prevention Program (ECHO): an ecologically-based intervention delivered by home visitors for newborns and their mothers. BMC Public Health. 2015 Jun 24;15:584. doi: 10.1186/s12889-015-1897-9.

  PMID: 26104068 DERIVED

MeSH Terms

Conditions

Body Weight Changes; Pediatric Obesity; Breast Feeding

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Feeding Behavior; Behavior

Study Officials

• Michelle M Cloutier, MD

  Connecticut Children's Medical Centr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: February 3, 2014
• Study Start: June 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 3, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)