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Starting Early Obesity Prevention Program

Primary Purpose

Childhood Obesity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family groups
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Obesity, Child, Hispanic, Prevention, Nutrition, Parenting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Bellevue Hospital Center Ambulatory Care Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Family groups

Standard care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Reduction in the prevalence and degree of obesity at age 3 years
Continuous and dichotomized measures (BMI percentiles)
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
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
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
Reduction in infant and child excess weight gain
Continuous anthropometric measures (weight for length z-scores)
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
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
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.
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
Participant satisfaction
We will assess program satisfaction

Secondary Outcome Measures

Full Information

First Posted
February 24, 2012
Last Updated
October 24, 2023
Sponsor
NYU Langone Health
Collaborators
United States Department of Agriculture (USDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01541761
Brief Title
Starting Early Obesity Prevention Program
Official Title
RCT Testing the Effectiveness of an Early Obesity Prevention Program
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2012 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
United States Department of Agriculture (USDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Obesity, Child, Hispanic, Prevention, Nutrition, Parenting

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
338 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family groups
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Mothers enrolled into the control group will continue to receive care from their pediatrician in the primary care clinic.
Intervention Type
Behavioral
Intervention Name(s)
Family groups
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in the prevalence and degree of obesity at age 3 years
Description
Continuous and dichotomized measures (BMI percentiles)
Time Frame
3 years
Title
Improvement in infant diet composition
Description
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
Time Frame
1-3 years
Title
Improvement in infant lifestyle behaviors associated with increased risk of obesity.
Description
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
Time Frame
1-3 years
Title
Improvement in parent feeding knowledge, attitudes, styles and practices
Description
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
Time Frame
1-3 years
Title
Reduction in infant and child excess weight gain
Description
Continuous anthropometric measures (weight for length z-scores)
Time Frame
1-3 years
Title
Additional Outcome Measures for the Expanded Starting Early Program: Preschool intervention
Description
Will be feasible, intervention mothers will have improved nutrition knowledge, and feeding attitudes, styles and behaviors
Time Frame
2-5 years
Title
Additional Outcome Measures for the Expanded Starting Early Program: Prenatal Intervention
Description
Will be feasible, ii) intervention women will have improved nutrition knowledge and behaviors, iii) intervention women will have improved gestational weight gain
Time Frame
2-5 years
Title
Feasibility process measures:
Description
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.
Time Frame
2-5 years
Title
Participant engagement
Description
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
Time Frame
2-5 years
Title
Participant satisfaction
Description
We will assess program satisfaction
Time Frame
2-5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Jo Messito, MD
Organizational Affiliation
NYU School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rachel Gross, MD MS
Organizational Affiliation
Children's Hospital at Montefiore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bellevue Hospital Center Ambulatory Care Clinic
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36255444
Citation
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.
Results Reference
derived
PubMed Identifier
36112108
Citation
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.
Results Reference
derived
PubMed Identifier
32883807
Citation
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.
Results Reference
derived
PubMed Identifier
28332324
Citation
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.
Results Reference
derived
PubMed Identifier
27113376
Citation
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.
Results Reference
derived

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Starting Early Obesity Prevention Program

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