Starting Early Obesity Prevention Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01541761
Recruitment Status : Active, not recruiting
First Posted : March 1, 2012
Last Update Posted : October 12, 2017
United States Department of Agriculture (USDA)
Information provided by (Responsible Party):
New York University School of Medicine

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 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

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.

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)

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01541761

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: New York University School of Medicine Identifier: NCT01541761     History of Changes
Other Study ID Numbers: 10-02175
First Posted: March 1, 2012    Key Record Dates
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:

Additional relevant MeSH terms:
Pediatric Obesity
Nutrition Disorders
Body Weight
Signs and Symptoms