ECHO: Early Childhood Obesity Prevention Program

Sponsor

Connecticut Children's Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02052518

Collaborator

University of Connecticut (Other), UConn Health (Other)

Enrollment

Location

Arms

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Body Weight Changes	Behavioral: Experimental	N/A

Detailed Description

See Manuscript: 125. 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, 15:584 PMID 26073106, 2015.

Study Design

Study Type:

Interventional

Actual Enrollment :

57 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Early Childhood Obesity Prevention Program: Building Better Families and Communities

Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Enhanced NFN Home Program 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 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 Other Names: Enhanced NFN Home Program
Placebo Comparator: Nurturing Family Network Home Visitation Mothers will receive the standard of care from the Nurturing Families Network Home Visitation program	Behavioral: Experimental 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 Other Names: Enhanced NFN Home Program

Arm

Intervention/Treatment

Experimental: Enhanced NFN Home Program

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

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

Other Names:

Enhanced NFN Home Program

Placebo Comparator: Nurturing Family Network Home Visitation

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

Behavioral: Experimental

Other Names:

Enhanced NFN Home Program

Outcome Measures

Primary Outcome Measures

Number of months of breast feeding [6 and 12 months]
Number of months that child is breastfed

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 1 Month

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Connecticut Children's Medical Center	Hartford	Connecticut	United States	06106

Sponsors and Collaborators

Connecticut Children's Medical Center
University of Connecticut
UConn Health

Investigators

Principal Investigator: Michelle M Cloutier, MD, Connecticut Children's Medical Centr

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michelle Cloutier, MD, Professor of Pediatrics, Connecticut Children's Medical Center

ClinicalTrials.gov Identifier:

NCT02052518

Other Study ID Numbers:

HD073966-02

First Posted:

Feb 3, 2014

Last Update Posted:

Mar 3, 2017

Last Verified:

Feb 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by Michelle Cloutier, MD, Professor of Pediatrics, Connecticut Children's Medical Center

Childhood obesity

Breastfeeding

Introduction of solids

Introduction of juice

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 3, 2017