Early Childhood Obesity Prevention Program

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Childhood Obesity Prevention Program: Building Better Families and Communities

Conditions
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Body Weight Changes

Intervention / Treatment
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* Behavioral: Experimental


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced NFN Home Program<br>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<br>* 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<br>* Other names: Enhanced NFN Home Program;|
| Placebo Comparator: Nurturing Family Network Home Visitation<br>Mothers will receive the standard of care from the Nurturing Families Network Home Visitation program | Behavioral: Experimental<br>* 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<br>* Other names: Enhanced NFN Home Program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of months of breast feeding | Number of months that child is breastfed | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Childhood obesity, Breastfeeding, Introduction of solids, Introduction of juice