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Completed

NCT Number: NCT02052518

Early Childhood Obesity Prevention Program

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).

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Key information

Conditions

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

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Enhanced NFN Home Program

Primary outcomes

  1. Number of months of breast feeding

    Time frame: 6 and 12 months

    Number of months that child is breastfed

Sponsors and collaborators

Lead sponsor

Connecticut Children's Medical Center

Other

Collaborators

  • UConn Health
  • University of Connecticut

Registry information

Official study title

Early Childhood Obesity Prevention Program: Building Better Families and Communities

Acronym: ECHO

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 3, 2014
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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