Starting Early Obesity Prevention Program

NCT01541761 | Completed

• 1 other identifier: 10-02175
• Study Type: interventional
• Target: 566
• Locations: 1 country
• Sites: 1

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

Conditions

Childhood Obesity

Keywords

Obesity; Child; Hispanic; Prevention; Nutrition; Parenting

Outcome Measures

Primary Outcomes (10)

• Reduction in the prevalence and degree of obesity at age 3 years

  Continuous and dichotomized measures (BMI percentiles)

  3 years

• Improvement in infant diet composition

  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

  1-3 years

• Improvement in infant lifestyle behaviors associated with increased risk of obesity.

  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

  1-3 years

• Improvement in parent feeding knowledge, attitudes, styles and practices

  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

  1-3 years

• Reduction in infant and child excess weight gain

  Continuous anthropometric measures (weight for length z-scores)

  1-3 years

• Additional Outcome Measures for the Expanded Starting Early Program: Preschool intervention

  Will be feasible, intervention mothers will have improved nutrition knowledge, and feeding attitudes, styles and behaviors

  2-5 years

• Additional Outcome Measures for the Expanded Starting Early Program: Prenatal Intervention

  Will be feasible, ii) intervention women will have improved nutrition knowledge and behaviors, iii) intervention women will have improved gestational weight gain

  2-5 years

• Feasibility process measures:

  Study population eligibility and enrollment, Proportion of pregnant women approached who meet eligibility criteria, Proportion of women meeting eligibility criteria who enroll These proportions will be calculated using study recruitment records.

  2-5 years

• Participant engagement

  Proportion of enrolled mother-infant dyads that participate in the different aspects of the program. This will include the number of individual sessions with healthy steps, the number of individual sessions with the health educator, the number and type of referrals to community resources provided, and the number of Nutrition and Parenting Support Groups attended. This will enable us to determine the length of engagement in the program, proportion of enrolled mother-infant dyads that complete each study measure

  2-5 years

• Participant satisfaction

  We will assess program satisfaction

  2-5 years

Study Arms (2)

Family groups

EXPERIMENTAL

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

Standard care

NO INTERVENTION

Mothers enrolled into the control group will continue to receive care from their pediatrician in the primary care clinic.

Interventions

Family groups BEHAVIORAL

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.

Family groups

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

Bellevue Hospital Center Ambulatory Care Clinic

New York, New York, 10016, United States

Location

Related Publications (6)

• Duh-Leong C, Messito MJ, Katzow MW, Kim CN, Mendelsohn AL, Scott MA, Gross RS. Prenatal and Pediatric Primary Care-Based Child Obesity Prevention: Effects of Adverse Social Determinants of Health on Intervention Attendance and Impact. Child Obes. 2024 Oct;20(7):476-484. doi: 10.1089/chi.2023.0149. Epub 2024 Feb 1.

  PMID: 38301173 DERIVED

• 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.

  PMID: 36255444 DERIVED

• 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.

  PMID: 36112108 DERIVED

• 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.

  PMID: 32883807 DERIVED

• 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.

  PMID: 28332324 DERIVED

• 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.

  PMID: 27113376 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary Jo Messito, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

• Rachel Gross, MD MS

  Children's Hospital at Montefiore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: March 1, 2012
• Study Start: April 1, 2012
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

US (1)