Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06116422 · ClinicalTrials.gov registry record · NA
Nutrition and Obesity in Under-Represented Populations: Food Insecurity Research to Advance Science and Improve Health
A NA study of Pediatric Obesity and Food Insecurity, sponsored by Duke University.
- Recruiting
- Registry status
- NA
- Development phase
- 228
- Enrollment target
- 1
- Study location
NCT06116422: Recruiting NA study of Pediatric Obesity and Food Insecurity, sponsored by Duke University.
NCT06116422 is a NA study of Pediatric Obesity and Food Insecurity that is actively recruiting participants, run by Duke University. The registered enrollment target is 228 participants, roughly in line with the 225-participant average among 45 other Pediatric Obesity trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06116422, a NA study of Pediatric Obesity and Food Insecurity, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- NA
- Development phase
- 228 participants
- Enrollment target
- 1
- Study location
Study Summary
Food insecurity is associated with obesity in children, and childhood obesity leads to long term health consequences. While existing research shows that food benefit programs reduce food insecurity, little is known about the mediating factors between food benefit programs and child health. The purpose of this study is to understand if the resolution of food insecurity in young children with early onset obesity can improve body mass index (BMI) over one year, and if so, by what mechanisms. The investigators will conduct a randomized comparative effectiveness study among infants (n=228) aged 12 months at risk for food insecurity and deliver two different food security interventions. Both will provide families with $50/week for one year of study enrollment. The first group will receive this as an unrestricted cash benefit ("cash benefit group") and the second group will receive this as a benefit in the form of weekly grocery purchases with the support of a trained nutrition expert to guide healthy grocery purchasing ("grocery benefit group"). The investigators will also construct a contemporary comparison cohort of infants meeting the inclusion/exclusion criteria from the electronic health record, using propensity score matching to allow comparisons between both intervention groups and usual care. The primary endpoint is difference in BMI at 12 months post-enrollment (24 months of age). Secondary outcomes include measures of nutrition, food security, electronic health record data related to general child health, and other factors related to parental stress and unmet social needs. Patients will have the opportunity to participate in post-study interviews to report on intervention satisfaction, and facilitators and barriers of infant feeding. Data analysis will be conducted by a trained statistician (Duke Biostatistics, Epidemiology, and Research Design; BERD) and will employ a two-means test for a repeated-measures design. The benefits to participants outweigh the minim
Primary Outcome
At 12 months post-enrollment (24 months of age).
Conditions Studied
Interventions
- BEHAVIORAL Grocery intervention - unrestricted
- BEHAVIORAL Grocery intervention - restricted
Study Locations (1)
North Carolina
- North Duke Street Pediatrics - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 228 participants |
| Start Date | 2024-05-30 |
| Est. Completion | 2027-12-31 |
| Phase | NA |
What NCT06116422 shows while recruiting
NCT06116422 is an interventional study that assigns participants to a tested intervention. The registered 228 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 225-participant average among 45 other Pediatric Obesity trials with a reported enrollment target.
The record links to 4 conditions, with Pediatric Obesity appearing as the primary indexed condition, and to 2 interventions - of which Grocery intervention - unrestricted is the first listed.
NCT06116422 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06116422 about?
NCT06116422 is a clinical study titled "Nutrition and Obesity in Under-Represented Populations: Food Insecurity Research to Advance Science and Improve Health". Food insecurity is associated with obesity in children, and childhood obesity leads to long term health consequences. While existing research shows that food benefit programs reduce food insecurity, little is known about the mediating factors between food benefit programs and child health. The purpo...
What is the current status of trial NCT06116422?
This trial is currently recruiting. It is a NA study. The enrollment target is 228 participants. The study started on 2024-05-30. Estimated completion is 2027-12-31.
What conditions does trial NCT06116422 study?
This clinical trial studies the following conditions: Pediatric Obesity, Food Insecurity, Nutrition, Healthy, Nutrition Poor.
What interventions are being tested in trial NCT06116422?
The interventions under investigation include: Grocery intervention - unrestricted (BEHAVIORAL), Grocery intervention - restricted (BEHAVIORAL).
Who is sponsoring clinical trial NCT06116422?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06116422 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pediatric Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06116422's enrollment target sits among peer trials
228 12th of 45 higher than 34 of 45 other Pediatric Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pediatric Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)
RECRUITING · NA
-
iAmHealthy Clinical Practice Guideline (CPG)
RECRUITING · NA
-
Monitoring Eating Across Locations (MEAL) - Timing, Intake, and Mealtime Evaluation (TIME)
RECRUITING · NA
-
Growing Healthy Children and Families in Rural Arkansas
RECRUITING · NA
-
Time Limited Eating in Adolescents With Type 2 Diabetes (KT2D)
RECRUITING · NA
-
Use of Continuous Glucose Monitors in Children and Adolescents With Obesity
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05107908 · 228 participants · NA
Neuronal and Behavioral Effects of an Implicit Priming Approach to Improve Eating Behaviors in Obesity
- NCT05547698 · 228 participants · NA
A Study of Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation
- NCT05630963 · 228 participants
Beyond Monoamines: The Role of the Nociceptin/Orphanin FQ Receptor in Major Depression
- NCT06073665 · 228 participants · Phase 4
Dosing of LT4 in Older Individuals
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI