Starting Early Obesity Prevention Program

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Hypothesis: Compared to controls, the intervention group will show reduced obesity and improved parent feeding knowledge and increased healthy feeding attitudes, styles and practices

Condition or disease	Intervention/treatment	Phase
Childhood Obesity	Behavioral: Family groups	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	550 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	RCT Testing the Effectiveness of an Early Obesity Prevention Program
Study Start Date :	April 2012
Estimated Primary Completion Date :	July 2018
Estimated Study Completion Date :	July 2019

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Reduction in the prevalence and degree of obesity at age 3 years [ Time Frame: 3 years ]
   Continuous and dichotomized measures (BMI percentiles)
2. Improvement in infant diet composition [ Time Frame: 1-3 years ]

   Diets of intervention group infants and children will be more likely to follow recommended guidelines including:

   i) Increased breastfeeding rates and duration ii) Appropriate timing of introduction to solids iii) Appropriate timing of bottle weaning iv) Increased fruit and vegetable consumption v) Decreased fast and junk food consumption vi) Decreased sugary beverage consumption vii) Age-appropriate portion sizes

3. Improvement in infant lifestyle behaviors associated with increased risk of obesity. [ Time Frame: 1-3 years ]

   Measures of lifestyle behaviors among infants and children receiving intervention will be more likely to follow recommended guidelines than those of the control group including:

   i) Better sleep habits ii) Reduced screen time iii) Increased physical activity

4. Improvement in parent feeding knowledge, attitudes, styles and practices [ Time Frame: 1-3 years ]

   Parent feeding knowledge, attitudes, styles and practices in the intervention group will be healthier than those of the control group including:

   i) Awareness of healthy child weight ii) Improved knowledge of optimal feeding practices iii) More responsive feeding style

5. Reduction in infant and child excess weight gain [ Time Frame: 1-3 years ]
   Continuous anthropometric measures (weight for length z-scores)

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Locations

United States, New York
Bellevue Hospital Center Ambulatory Care Clinic
New York, New York, United States, 10016

Sponsors and Collaborators

New York University School of Medicine

United States Department of Agriculture (USDA)

Investigators

Principal Investigator:	Mary Jo Messito, MD	NYU School of Medicine
Principal Investigator:	Rachel Gross, MD MS	Children's Hospital at Montefiore

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

Responsible Party:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT01541761 History of Changes
Other Study ID Numbers:	10-02175
First Posted:	March 1, 2012
Last Update Posted:	October 12, 2017
Last Verified:	October 2017

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by New York University School of Medicine:

Obesity; Child; Hispanic	Prevention; Nutrition; Parenting

Additional relevant MeSH terms:

Obesity; Pediatric Obesity; Overnutrition; Nutrition Disorders	Overweight; Body Weight; Signs and Symptoms