Starting 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
|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|
- 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)
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541761
|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 firstname.lastname@example.org|
|Principal Investigator:||Mary Jo Messito, MD||NYU School of Medicine|
|Principal Investigator:||Rachel Gross, MD MS||Children's Hospital at Montefiore|