Starting Early Obesity Prevention Program



Status:Active, not recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:1/31/2019
Start Date:April 2012
End Date:July 2022

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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.

The proposed research included in the funding continuation is titled: "Starting Early:
Expansion of a Primary Care-Based Early Child Obesity Prevention Program". It adds three
major components to the current project: 1) Following the original Starting Early cohort
until age 5; 2) Developing and piloting an extended Starting Early preschool intervention for
children aged 3-5 years.; 3) Developing and piloting an extended Starting Early prenatal
intervention for women in the 1st trimester of pregnancy. A new cohort of 200 women in the
first trimester of pregnancy will be recruited for the prenatal intervention; all women will
receive the intervention in this feasibility trial.

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. The new components
of the expanded Starting Early Program will be feasible: Families will participate in the
preschool intervention, and pregnant women will enroll in the prenatal intervention.

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
We found this trial at
1
site
462 1st Avenue
New York, New York 10016
?
mi
from
New York, NY
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