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Early Childhood Obesity Prevention Program (ECHO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02052518
Recruitment Status : Completed
First Posted : February 3, 2014
Last Update Posted : March 3, 2017
Sponsor:
Collaborators:
University of Connecticut
UConn Health
Information provided by (Responsible Party):
Michelle Cloutier, MD, Connecticut Children's Medical Center

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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).

Condition or disease Intervention/treatment Phase
Body Weight Changes Behavioral: Experimental Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Early Childhood Obesity Prevention Program: Building Better Families and Communities
Study Start Date : June 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Number of months of breast feeding [ Time Frame: 6 and 12 months ]
    Number of months that child is breastfed


Eligibility Criteria
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02052518


Locations
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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
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Principal Investigator: Michelle M Cloutier, MD Connecticut Children's Medical Centr
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Michelle Cloutier, MD, Professor of Pediatrics, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier: NCT02052518    
Other Study ID Numbers: HD073966-02
First Posted: February 3, 2014    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
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 Michelle Cloutier, MD, Connecticut Children's Medical Center:
Childhood obesity
Breastfeeding
Introduction of solids
Introduction of juice
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Body Weight
Body Weight Changes
 Overnutrition
Nutrition Disorders
Overweight