Body Weight Changes Clinical Trial
— ECHOOfficial title:
Early Childhood Obesity Prevention Program: Building Better Families and Communities
Verified date | February 2017 |
Source | Connecticut Children's Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 57 |
Est. completion date | January 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 1 Month |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Connecticut Children's Medical Center | Hartford | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Connecticut Children's Medical Center | UConn Health, University of Connecticut |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of months of breast feeding | Number of months that child is breastfed | 6 and 12 months |
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