Clinical trial Recruiting at 1 site Interventional Ages 12 Months to 24 Months

Understanding how food insecurity affects childhood obesity

Official title: Nutrition and Obesity in Under-Represented Populations: Food Insecurity Research to Advance Science and Improve Health: A Multi-disciplinary Approach for Study and Mitigation of Food Insecurity and Obesity

Run by Duke University · NCT06116422 · Data updated 2026-11-12

This study is testing if giving financial help to families can reduce obesity in infants at risk of food insecurity by comparing two different ways of providing that support.

Quick facts

Study typeInterventional
Ages12 Months to 24 Months
SexAll
Enrollment228 (estimated)
SponsorDuke University
Academic / other
Locations1 site (Durham, North Carolina)
StatusRecruiting
StartedMay 30, 2024
Main results expectedMarch 31, 2027
Study endsDecember 31, 2027
Registry record updatedJanuary 16, 2026
Trial IDNCT06116422 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are infants aged 9-12 months who are Medicaid and WIC-eligible and have early-onset obesity.

Probably not a fit

Patients diagnosed with monogenic obesity or those planning to move from the area in the next 12 months may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the relationship between food insecurity and obesity in young children, specifically focusing on infants aged 9-12 months who are at risk for food insecurity. It aims to determine if resolving food insecurity through two different interventions—unrestricted cash benefits or guided grocery purchases—can improve body mass index (BMI) over the course of one year. The study will enroll 228 infants and their caregivers, providing them with financial support to assess the impact on child health outcomes. The research will also explore the mechanisms by which these interventions may influence obesity rates.

Why it matters

Potential benefit: If successful, this study could lead to improved health outcomes for children at risk of obesity by addressing food insecurity.

How similar studies have gone: Previous studies have shown that food benefit programs can reduce food insecurity, but this specific approach to understanding its impact on childhood obesity is novel.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • North Duke Street Pediatrics
    Durham, North Carolina, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.