Starting Early Obesity Prevention Program

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by New York University School of Medicine
Sponsor:
Collaborator:
USDA Beltsville Human Nutrition Research Center
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01541761
First received: February 24, 2012
Last updated: September 23, 2014
Last verified: September 2014
  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

Resource links provided by NLM:


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
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 Recruiting
New York City, New York, United States, 10016
Contact: Mary Jo Messito, MD    212-562-3155    mary.messito@nyumc.org   
Sponsors and Collaborators
New York University School of Medicine
USDA Beltsville Human Nutrition Research Center
Investigators
Principal Investigator: Mary Jo Messito, MD NYU School of Medicine
Principal Investigator: Rachel Gross, MD MS Children's Hospital at Montefiore
  More Information

No publications provided

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: September 23, 2014
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
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014