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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 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.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06116422
The ClinicalTrials.gov registry entry for NCT06116422 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 228 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 225-participant average among 45 other Pediatric Obesity trials with a reported enrollment target. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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