Clinical trial NCT01541761: Starting Early Obesity Prevention Program
Official title: RCT Testing the Effectiveness of an Early Obesity Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Obesity
Child
Hispanic
Prevention
Nutrition
Parenting
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
First posted: 2012-03-01
Enrollment: 566
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

Detailed 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in the prevalence and degree of obesity at age 3 years
timeFrame: 3 years
measure: Improvement in infant diet composition
timeFrame: 1-3 years
measure: Improvement in infant lifestyle behaviors associated with increased risk of obesity.
timeFrame: 1-3 years
measure: Improvement in parent feeding knowledge, attitudes, styles and practices
timeFrame: 1-3 years
measure: Reduction in infant and child excess weight gain
timeFrame: 1-3 years
measure: Additional Outcome Measures for the Expanded Starting Early Program: Preschool intervention
timeFrame: 2-5 years
measure: Additional Outcome Measures for the Expanded Starting Early Program: Prenatal Intervention
timeFrame: 2-5 years
measure: Feasibility process measures:
timeFrame: 2-5 years
measure: Participant engagement
timeFrame: 2-5 years
measure: Participant satisfaction
timeFrame: 2-5 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Bellevue Hospital Center Ambulatory Care Clinic
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Mary Jo Messito, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital at Montefiore
name: Rachel Gross, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vandyousefi S, Messito MJ, Scott MA, Gross RS. Do Appetite Traits Mediate the Link Between Birth Weight and Later Child Weight in Low-Income Hispanic Families? Child Obes. 2023 Oct;19(7):489-497. doi: 10.1089/chi.2022.0124. Epub 2022 Oct 17.
citation: Katzow MW, Messito MJ, Mendelsohn AL, Scott MA, Gross RS. Protective Effect of Prenatal Social Support on the Intergenerational Transmission of Obesity in Low-Income Hispanic Families. Child Obes. 2023 Sep;19(6):382-390. doi: 10.1089/chi.2021.0306. Epub 2022 Sep 15.
citation: Messito MJ, Mendelsohn AL, Katzow MW, Scott MA, Vandyousefi S, Gross RS. Prenatal and Pediatric Primary Care-Based Child Obesity Prevention Program: A Randomized Trial. Pediatrics. 2020 Oct;146(4):e20200709. doi: 10.1542/peds.2020-0709. Epub 2020 Sep 3.
citation: Gross RS, Mendelsohn AL, Yin HS, Tomopoulos S, Gross MB, Scheinmann R, Messito MJ. Randomized controlled trial of an early child obesity prevention intervention: Impacts on infant tummy time. Obesity (Silver Spring). 2017 May;25(5):920-927. doi: 10.1002/oby.21779. Epub 2017 Mar 22.
citation: 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.