This trial is active, not recruiting.

Condition childhood obesity
Treatment family groups
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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
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.
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)
Mothers enrolled into the control group will continue to receive care from their pediatrician in the primary care clinic.

Primary Outcomes

Reduction in the prevalence and degree of obesity at age 3 years
time frame: 3 years

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by New York University School of Medicine.