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Early Childhood Obesity Prevention Program (ECHO)

This study has been completed.
Sponsor:
Collaborators:
University of Connecticut
UConn Health
Information provided by (Responsible Party):
Michelle Cloutier, MD, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:
NCT02052518
First received: January 27, 2014
Last updated: February 28, 2017
Last verified: February 2017
  Purpose
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
Body Weight Changes
Behavioral: Experimental

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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:
  • Number of months of breast feeding [ Time Frame: 6 and 12 months ]
    Number of months that child is breastfed


Enrollment: 57
Study Start Date: June 2013
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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
Other Name: Enhanced NFN Home Program
Placebo Comparator: Nurturing Family Network Home Visitation
Mothers will receive the standard of care from the Nurturing Families Network Home Visitation program
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
Other Name: Enhanced NFN Home Program

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.
  Eligibility

Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT02052518

Locations
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Connecticut Children's Medical Center
University of Connecticut
UConn Health
Investigators
Principal Investigator: Michelle M Cloutier, MD Connecticut Children's Medical Centr
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michelle Cloutier, MD, Professor of Pediatrics, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier: NCT02052518     History of Changes
Other Study ID Numbers: HD073966-02
Study First Received: January 27, 2014
Last Updated: February 28, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: When final analysis has been completed and manuscripts have been published, data will be made available upon request to other investigators

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

Additional relevant MeSH terms:
Obesity
Pediatric Obesity
Body Weight
Body Weight Changes
Overnutrition
Nutrition Disorders
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on March 30, 2017