El Sendero: Pathways to Health Study

NCT05551650 | Enrolling By Invitation

• 1 other identifier: CHLA-21-00314
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

This project will continue to follow two birth cohorts of mother-infant Latino dyads through a series of new assessments at age 6y, with an emphasis on examining the the role early nutritional exposures, exposures to environmental toxins, and social determinants of health have on adiposity, eating behaviors, brain structure and function, cognitive outcomes, and chronic disease risk.

Conditions

Obesity, Childhood; Child Development

Keywords

Childhood; Brain development; Adiposity; Nutrition; HMOs; Air-pollution

Outcome Measures

Primary Outcomes (10)

• Child weight

  Weight (kg) will be measured using a portable digital scale.

  6 years old

• Child height

  Height (cm) will be measured using a stadiometer.

  6 years old

• Child BMI percentile at 6y

  Child height and weight will be used to calculate body mass index (BMI) and BMI percentiles.

  6 years old

• Child abdominal fat mass as measured by MRI

  An abdominal MRI using a 3.0 Philips Achieva will be used to measure visceral versus subcutaneous abdominal fat, in grams.

  6 years old

• Child Liver fat content as measured by MRI

  An abdominal MRI using a 3.0 Philips Achieva will be used to measure liver fat fraction, percent liver fat.

  6 years old

• Child cognitive capacity

  The child's cognitive capacity will be measured using the NIH Toolbox Cognition Battery, which is a standardized psychometrically rigorous tablet-based testing of core neuropsychological functions. Cognitive assessments will focus on visual attention and inhibitory control, cognitive flexibility/concept formation, working memory capacity, episodic memory, information processing speed, vocabulary knowledge, and oral reading skills.

  6 years old

• Child Brain imaging - Anatomical MRI

  A 3.0 Philips Achieva will be used to perform an anatomical MRI to measure the volume and shape of brain regions including thickness of the cortical mantle and local volumes (indentation and protrusions) of the cortical and white matter surfaces.

  6 years old

• Child Brain imaging - Perfusion Imaging (ASL)

  A 3.0 Philips Achieva will be used to perform Perfusion Imaging (ASL) to quantify regional cerebral blood flow (rCBF) at rest.

  6 years old

• Child Brain imaging - Resting-State Functional MRI (rs-fMRI)

  A 3.0 Philips Achieva will be used to perform a Resting-State Functional MRI (rs-fMRI) to measure correlations of neural activity between regions in the brain ("functional connectivity"). We will used Graph Theoretical Measures to characterize functional connectivity throughout the brain.

  6 years old

• Child Brain imaging- Diffusion Tensor Imaging (DTI)

  A 3.0 Philips Achieva will be used to perform Diffusion Tensor Imaging (DTI) to assess tissue organization within the brain, especially white matter fibers that connect one brain region to another. Measures will include: Fractional Anisotropy (FA) measuring the directional diffusion of water; Mean Diffusivity (MD), measuring the overall diffusion of water; Axial Diffusivity (AD) and Radial Diffusivity (RD) will be used to measure diffusion along hte long axis of diffusion or perpendicular to it.

  6 years old

Secondary Outcomes (18)

• Child feeding behavior

  6 years old

• Child behavior -Temperament

  6 years old

• Child glycemic control as measured by HbA1c

  6 years old

• Child glucose tolerance as measured by a continuous glucose monitor (CGM)

  6 years old

• Child fasting lipid profile

  6 years old

Eligibility Criteria

• Age: 6 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Normal, overweight or obese (\>25 BMI kg/m2) non-diabetic Hispanic mothers (18-59yrs) and their children (6y) from Los Angeles, CA.

You may qualify if:

• Mother's normal weight or overweight/obesity prior to pregnancy
• Mother's who self identify as Hispanic
• Mother's who are first-time moms
• Mother's who have or have had singleton births
• Mothers must be able/willing to understand the procedures of the study, and must be able to read English or Spanish at a 5th grade level

You may not qualify if:

• Physician diagnosis of a major medical illness (including type 1 or type 2 diabetes) or eating disorder in mothers
• Physical, mental, or cognitive issues that prevent participation
• Chronic use of any medication that may affect body weight or composition, insulin resistance, or lipid profiles
• Current smoking (more than 1 cigarette in the past week) or use of other recreational drugs
• Clinical diagnosis of gestational diabetes
• Pre-term/low birth weight infants, or diagnosis of any fetal abnormalities
• Mothers less than 18 years of age at the time of delivery will not be eligible as to avoid potential confounding from those subjects who might still be completing adolescent growth

Sponsors & Collaborators

• University of Southern California: lead
• University of Colorado, Denver: collaborator
• University of California, San Diego: collaborator

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and stool

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: September 23, 2022
• Study Start: September 1, 2021
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: May 20, 2024

Record last verified: 2024-05

Locations

US (1)