Starting Early Obesity Prevention Program
This trial is active, not recruiting.
|Sponsor||New York University School of Medicine|
|Collaborator||United States Department of Agriculture (USDA)|
|Start date||April 2012|
|End date||April 2017|
|Trial size||550 participants|
|Trial identifier||NCT01541761, USDA 2011-68001-30207|
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
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Reduction in the prevalence and degree of obesity at age 3 years
time frame: 3 years
Female participants at least 18 years old.
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
|Official title||RCT Testing the Effectiveness of an Early Obesity Prevention Program|
|Principal investigator||Mary Jo Messito, MD|
|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.|
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