Starting Early Obesity Prevention Program
This study is ongoing, but not recruiting participants.
Sponsor:
New York University School of Medicine
Collaborator:
United States Department of Agriculture (USDA)
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01541761
First received: February 24, 2012
Last updated: May 12, 2017
Last verified: May 2017
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Purpose
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 | Intervention |
|---|---|
|
Childhood Obesity |
Behavioral: Family groups |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Outcomes Assessor Primary Purpose: Prevention |
| Official Title: | RCT Testing the Effectiveness of an Early Obesity Prevention Program |
Further study details as provided by New York University School of Medicine:
Primary Outcome Measures:
- Reduction in the prevalence and degree of obesity at age 3 years [ Time Frame: 3 years ]Continuous and dichotomized measures (BMI percentiles)
| Estimated Enrollment: | 550 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | July 2019 |
| Estimated Primary Completion Date: | July 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541761
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541761
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01541761 History of Changes |
| Other Study ID Numbers: |
10-02175 |
| Study First Received: | February 24, 2012 |
| Last Updated: | May 12, 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 |
ClinicalTrials.gov processed this record on May 25, 2017