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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02052518
Other study ID # HD073966-02
Secondary ID
Status Completed
Phase N/A
First received January 27, 2014
Last updated February 28, 2017
Start date June 2013
Est. completion date January 2016

Study information

Verified date February 2017
Source Connecticut Children's Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Month
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Connecticut Children's Medical Center Hartford Connecticut

Sponsors (3)

Lead Sponsor Collaborator
Connecticut Children's Medical Center UConn Health, University of Connecticut

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of months of breast feeding Number of months that child is breastfed 6 and 12 months
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