ClinConnect ClinConnect Logo
Search / Trial NCT06116422

Nutrition and Obesity in Under-Represented Populations: Food Insecurity Research to Advance Science and Improve Health

Launched by DUKE UNIVERSITY · Oct 30, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how helping families with food insecurity can affect childhood obesity in young children. The study will involve infants aged 9 to 12 months who are at risk for food insecurity and have early-onset obesity, which means their weight is higher than most children their age. Researchers will provide two different types of support: one group will receive $50 a week in cash that they can spend as they wish, while another group will receive $50 a week for groceries, along with guidance from a nutrition expert to help them make healthy food choices. The main goal is to see if these interventions can improve the children's body weight and overall health over the course of a year.

To participate, infants need to be between 9 and 12 months old, at high risk for food insecurity, and have a higher than normal body mass index (BMI) for their age. Their primary caregiver should speak either English or Spanish. Families will have a chance to share their experiences in interviews after the study, and all personal information will be kept private and secure. This study is important because it aims to find effective ways to support families and improve health outcomes for children facing obesity and food insecurity.

Gender

ALL

Eligibility criteria

  • Inclusion:
  • Aged 9-12 months and their primary caregiver "parent".
  • Medicaid and WIC-eligible (proxy for "at risk for food insecurity")
  • World Health Organization BMI ≥ 85%ile at current or most recent encounter (early-onset obesity) OR ≥ 20 pounds at 9 months old.
  • Caregiver speaks either English or Spanish as their primary language.
  • Infant was born as a singleton infant.
  • Exclusion:
  • Diagnosed with monogenic obesity.
  • Plans to move from the area in the next 12 months.
  • Parent is currently pregnant.

About Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Durham, North Carolina, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported