Early Childhood Obesity Prevention Program (ECHO)
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).
|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|
- 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
- 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.
|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)|
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02052518
|Contact: Michelle M Cloutier, MD||860 837 firstname.lastname@example.org|
|Contact: James Wiley||860 837 email@example.com|
|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|