Understanding how food insecurity affects childhood obesity
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
NA · Duke University · NCT06116422
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 228 (estimated) |
| Ages | 12 Months to 24 Months |
| Sex | All |
| Sponsor | Duke University (other) |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06116422 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are infants aged 9-12 months who are Medicaid and WIC-eligible and have early-onset obesity.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Durham, North Carolina
- North Duke Street Pediatrics — Durham, North Carolina, United States (RECRUITING)
Study contacts
- Study coordinator: Steph Bryant, MPH, RD
- Email: stephanie.l.bryant@duke.edu
- Phone: 919-620-5305
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pediatric Obesity, Food Insecurity, Nutrition, Healthy, Nutrition Poor