Early Childhood Obesity Prevention Program

NCT ID: NCT02052518

Last Updated: 2017-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-01-31

Brief Summary

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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

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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.

Conditions

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Body Weight Changes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Experimental

Intervention Type 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

Nurturing Family Network Home Visitation

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

Group Type PLACEBO_COMPARATOR

Experimental

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

Other Intervention Names

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Enhanced NFN Home Program

Eligibility Criteria

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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
Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Connecticut

OTHER

Sponsor Role collaborator

UConn Health

OTHER

Sponsor Role collaborator

Connecticut Children's Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Michelle Cloutier, MD

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michelle M Cloutier, MD

Role: PRINCIPAL_INVESTIGATOR

Connecticut Children's Medical Centr

Locations

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Connecticut Children's Medical Center

Hartford, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26104068 (View on PubMed)

Other Identifiers

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HD073966-02

Identifier Type: -

Identifier Source: org_study_id

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