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Starting Early Obesity Prevention Program

This study is ongoing, but not recruiting participants.
United States Department of Agriculture (USDA)
Information provided by (Responsible Party):
New York University School of Medicine Identifier:
First received: February 24, 2012
Last updated: May 12, 2017
Last verified: May 2017

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
Intervention Model: Parallel Assignment
Masking: Single (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 ]
    Continuous and dichotomized measures (BMI percentiles)

Estimated Enrollment: 550
Study Start Date: April 2012
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2018 (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.

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

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 identifier: NCT01541761

United States, New York
Bellevue Hospital Center Ambulatory Care Clinic
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
United States Department of Agriculture (USDA)
Principal Investigator: Mary Jo Messito, MD NYU School of Medicine
Principal Investigator: Rachel Gross, MD MS Children's Hospital at Montefiore
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: New York University School of Medicine Identifier: NCT01541761     History of Changes
Other Study ID Numbers: 10-02175
Study First Received: February 24, 2012
Last Updated: May 12, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by New York University School of Medicine:

Additional relevant MeSH terms:
Pediatric Obesity
Nutrition Disorders
Body Weight
Signs and Symptoms processed this record on September 19, 2017