Starting Early Obesity Prevention Program

Childhood Obesity Clinical Trial

Official title:

RCT Testing the Effectiveness of an Early Obesity Prevention Program

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01541761
• Other study ID #: 10-02175
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2012
• Est. completion date: April 30, 2024

Study information

• Verified date: October 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 338
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Bellevue Hospital Center Ambulatory Care Clinic	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the prevalence and degree of obesity at age 3 years	Continuous and dichotomized measures (BMI percentiles)	3 years
Primary	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
Primary	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
Primary	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
Primary	Reduction in infant and child excess weight gain	Continuous anthropometric measures (weight for length z-scores)	1-3 years
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Participant satisfaction	We will assess program satisfaction	2-5 years