Early Childhood Obesity Prevention Program

Not Applicable

Completed

• Conditions: Body Weight Changes
• Interventions: Behavioral: Experimental

• Registration Number: NCT02052518
• Lead Sponsor: Connecticut Children's Medical Center

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).

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 Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-01-27
• Study First Submitted QC: 2014-01-30
• Study First Posted: 2014-02-03
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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.
Nurturing Family Network Home Visitation	Experimental	Mothers will receive the standard of care from the Nurturing Families Network Home Visitation program

Primary Outcome Measures

Name	Time	Method
Number of months of breast feeding	6 and 12 months	Number of months that child is breastfed

Trial Locations

Locations (1)

Connecticut Children's Medical Center; 🇺🇸 Hartford, Connecticut, United States