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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: May 12, 2017
Last verified: May 2017

February 24, 2012
May 12, 2017
April 2012
July 2018   (Final data collection date for primary outcome measure)
Reduction in the prevalence and degree of obesity at age 3 years [ Time Frame: 3 years ]
Continuous and dichotomized measures (BMI percentiles)
Same as current
Complete list of historical versions of study NCT01541761 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Starting Early Obesity Prevention Program
RCT Testing the Effectiveness of an Early Obesity Prevention Program

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

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Prevention
Childhood Obesity
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.
  • 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.
    Intervention: Behavioral: Family groups
  • No Intervention: Standard care
    Mothers enrolled into the control group will continue to receive care from their pediatrician in the primary care clinic.
Gross RS, Mendelsohn AL, Gross MB, Scheinmann R, Messito MJ. Randomized Controlled Trial of a Primary Care-Based Child Obesity Prevention Intervention on Infant Feeding Practices. J Pediatr. 2016 Jul;174:171-177.e2. doi: 10.1016/j.jpeds.2016.03.060. Epub 2016 Apr 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
550
July 2019
July 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01541761
10-02175
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
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New York University School of Medicine
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
New York University School of Medicine
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP