Trial record 20 of 40 for:    Open Studies | "nutrition disorders" AND infant

Early Childhood Obesity Prevention Program (ECHO)

This study is currently recruiting participants.
Verified January 2014 by Connecticut Children's Medical Center
Sponsor:
Collaborators:
University of Connecticut
University of Connecticut Health Center
Information provided by (Responsible Party):
Michelle Cloutier, MD, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:
NCT02052518
First received: January 27, 2014
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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 Intervention
Weight Status in Infants
Behavioral: Intervention

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Connecticut Children's Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
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)
Arms Assigned Interventions
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.
Behavioral: Intervention
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

  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02052518

Contacts
Contact: Michelle M Cloutier, MD 860 837 5346 mclouti@connecticutchildrens.org
Contact: James Wiley 860 837 5331 jwiley01@connecticutchildrens.org

Locations
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         
Sponsors and Collaborators
Connecticut Children's Medical Center
University of Connecticut
University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: Michelle Cloutier, MD, Professor of Pediatrics, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier: NCT02052518     History of Changes
Other Study ID Numbers: HD073966-02
Study First Received: January 27, 2014
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Connecticut Children's Medical Center:
Childhood obesity
Breastfeeding
Introduction of solids
Introduction of juice

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014