Starting Early Obesity Prevention Program

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

United States Department of Agriculture (USDA)

Information provided by (Responsible Party):

New York University School of Medicine

ClinicalTrials.gov Identifier:

NCT01541761

First received: February 24, 2012

Last updated: April 5, 2016

Last verified: April 2016

History of Changes

Purpose

The proposed study is a randomized controlled trial to test the effectiveness of a primary care, family-centered child obesity prevention program beginning in pregnancy and continuing throughout the first three years of life compared to routine standard of care. The study aims to reduce the prevalence of obesity at age three, improve child diet composition and healthy lifestyle behaviors. Pregnant women will be enrolled from a large urban medical center serving primarily low-income immigrant Latino families. The intervention "Starting Early" will consist of three components. 1) Family Groups: interactive groups coordinated with the child's primary care visits and led by a Nutritionist/ Child Developmental Specialist. 2) Nutritional Video: a culturally-specific bilingual early nutrition video will be incorporated into family group discussions. 3) Plain Language Handouts: given to reinforce the curriculum from the family groups.

Hypothesis: Compared to controls, the intervention group will show reduced obesity and improved parent feeding knowledge and increased healthy feeding attitudes, styles and practices

Condition	Intervention
Childhood Obesity	Behavioral: Family groups


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	RCT Testing the Effectiveness of an Early Obesity Prevention Program

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:

Reduction in the prevalence and degree of obesity at age 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Continuous and dichotomized measures (BMI percentiles)


Estimated Enrollment:	550
Study Start Date:	April 2012
Estimated Study Completion Date:	April 2017
Estimated Primary Completion Date:	April 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Family groups Intervention group members will participate in family groups focused on early childhood obesity prevention in addition to standard care from pediatricians at the primary care clinic.	Behavioral: Family groups The group sessions are designed to facilitate on-going interaction among consistent groups of 6 - 8 parents and other care givers with infants the same age and will be coordinated with scheduled well child care visits. They will be conducted in English and Spanish. The groups will focus on nutrition and, parenting.
No Intervention: Standard care Mothers enrolled into the control group will continue to receive care from their pediatrician in the primary care clinic.

Detailed Description:

Expected outcomes include: (1) Reduction in the prevalence and degree of obesity. (2) Improvement in child diet composition. (3) Improvement in parent feeding knowledge, attitudes, styles and practices including. (4) Improvement in lifestyle behaviors, such as sleep, screen time and physical activity, associated with increased risk of obesity. (5) Improvement in parent diet. Our secondary objective is to understand the mechanisms by which changes in parent knowledge and behavioral factors mediate impacts of the intervention on childhood obesity. We will also study relationships between potential moderators and intervention impacts.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Latina mother > 18 years with singleton uncomplicated pregnancy
Receiving prenatal care and the intention to receive pediatric care at Bellevue Hospital Center or Gouverneur Healthcare Services
Mother to be primary caregiver of child
Mother speaks fluent English or Spanish

Exclusion Criteria:

Maternal history of serious medical or psychiatric illness or drug or alcohol abuse
Family does not have a phone
Infants with severe medical problems that may affect feeding

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541761

Locations


United States, New York
Bellevue Hospital Center Ambulatory Care Clinic
New York City, New York, United States, 10016

Sponsors and Collaborators

New York University School of Medicine

United States Department of Agriculture (USDA)

Investigators


Principal Investigator:	Mary Jo Messito, MD	NYU School of Medicine
Principal Investigator:	Rachel Gross, MD MS	Children's Hospital at Montefiore

More Information


Responsible Party:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT01541761 History of Changes
Other Study ID Numbers:	USDA 2011-68001-30207
Study First Received:	February 24, 2012
Last Updated:	April 5, 2016
Health Authority:	United States: Institutional Review Board

Keywords provided by New York University School of Medicine:


Obesity Child Hispanic	Prevention Nutrition Parenting

Additional relevant MeSH terms:


Obesity Pediatric Obesity Overnutrition Nutrition Disorders	Overweight Body Weight Signs and Symptoms

ClinicalTrials.gov processed this record on September 23, 2016

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