Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Early Childhood Obesity Prevention Program (ECHO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Connecticut Children's Medical Center
University of Connecticut
University of Connecticut Health Center
Information provided by (Responsible Party):
Michelle Cloutier, MD, Connecticut Children's Medical Center Identifier:
First received: January 27, 2014
Last updated: January 30, 2014
Last verified: January 2014

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 Intervention
Weight Status in Infants
Behavioral: Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Early Childhood Obesity Prevention Program: Building Better Families and Communities

Resource links provided by NLM:

Further study details as provided by Connecticut Children's Medical Center:

Primary Outcome Measures:
  • Breastfeeding duration [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Number of months that child is breastfed

  • Introduction of solids [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Age at which solids were introduced

  • Introduction of juice [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Age at which juice was introduced

Secondary Outcome Measures:
  • BMI percentile [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    At 12 months, infants enrolled in the intervention will have a lower weight for length than control infants.

Estimated Enrollment: 60
Study Start Date: June 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enhanced Nurturing Families Network Home Program
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: Intervention
Intervention participants will receive behavioral counseling, will develop a Family Wellness Plan and will be linked to community resources.
Placebo Comparator: Nurturing Family Network Home Visitation
Mothers will receive the standard of care from the Nurturing Families Network Home Visitation program


Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02052518

Contact: Michelle M Cloutier, MD 860 837 5346
Contact: James Wiley 860 837 5331

United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Michelle M Cloutier, MD    860-837-5346      
Principal Investigator: Michelle M Cloutier, MD         
Sponsors and Collaborators
Connecticut Children's Medical Center
University of Connecticut
University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: Michelle Cloutier, MD, Professor of Pediatrics, Connecticut Children's Medical Center Identifier: NCT02052518     History of Changes
Other Study ID Numbers: HD073966-02
Study First Received: January 27, 2014
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Connecticut Children's Medical Center:
Childhood obesity
Introduction of solids
Introduction of juice

Additional relevant MeSH terms:
Pediatric Obesity
Nutrition Disorders
Overnutrition processed this record on February 27, 2015