Early Childhood Obesity Prevention Program (ECHO)
Primary Purpose
Body Weight Changes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental
Sponsored by
About this trial
This is an interventional prevention trial for Body Weight Changes focused on measuring Childhood obesity, Breastfeeding, Introduction of solids, Introduction of juice
Eligibility 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
Sites / Locations
- Connecticut Children's Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Enhanced NFN Home Program
Nurturing Family Network Home Visitation
Arm Description
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.
Mothers will receive the standard of care from the Nurturing Families Network Home Visitation program
Outcomes
Primary Outcome Measures
Number of months of breast feeding
Number of months that child is breastfed
Secondary Outcome Measures
Full Information
NCT ID
NCT02052518
First Posted
January 27, 2014
Last Updated
February 28, 2017
Sponsor
Connecticut Children's Medical Center
Collaborators
University of Connecticut, UConn Health
1. Study Identification
Unique Protocol Identification Number
NCT02052518
Brief Title
Early Childhood Obesity Prevention Program
Acronym
ECHO
Official Title
Early Childhood Obesity Prevention Program: Building Better Families and Communities
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Connecticut Children's Medical Center
Collaborators
University of Connecticut, UConn Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight Changes
Keywords
Childhood obesity, Breastfeeding, Introduction of solids, Introduction of juice
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enhanced NFN Home Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Nurturing Family Network Home Visitation
Arm Type
Placebo Comparator
Arm Description
Mothers will receive the standard of care from the Nurturing Families Network Home Visitation program
Intervention Type
Behavioral
Intervention Name(s)
Experimental
Other Intervention Name(s)
Enhanced NFN Home Program
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of months of breast feeding
Description
Number of months that child is breastfed
Time Frame
6 and 12 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle M Cloutier, MD
Organizational Affiliation
Connecticut Children's Medical Centr
Official's Role
Principal Investigator
Facility Information:
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
When final analysis has been completed and manuscripts have been published, data will be made available upon request to other investigators
Citations:
PubMed Identifier
26104068
Citation
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. 2015 Jun 24;15:584. doi: 10.1186/s12889-015-1897-9.
Results Reference
derived
Learn more about this trial
Early Childhood Obesity Prevention Program
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