Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT06116422

Conditions

Pediatric Obesity

Food Insecurity

Nutrition, Healthy

Nutrition Poor

Eligibility Criteria

Sex: All

Age: 1 - 2

Healthy Volunteers: Accepted

Interventions

Grocery intervention - unrestricted

Grocery intervention - restricted

Study Details

Brief 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 minimal risks of loss of privacy, and confidential information will be managed carefully to minimize this risk.

Conditions

Pediatric Obesity

Food Insecurity

Nutrition, Healthy

Nutrition Poor

Study ID

NCT06116422

Start date

May 30, 2024

Status verified date

Jan, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 2

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

228 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Cash Benefit Group

Provides financial support weekly, in the form of an unrestricted cash benefit. The investigators will partner with Held to provide the card to participants, load the card with $50/week for the 12 months of enrollment, and view the purchases at the vendor level using an existing dashboard Held maintains. Participants will also receive a monthly nutrition guidance brochure tailored to the infant's developmental stage.

active comparator: Grocery Benefit Group

Provides financial support weekly in the form of a grocery benefit. The investigators will enroll participants in the Food Lion MVP program, linking the account to a Duke email address. The study team will work with the participants to order $50 worth of groceries from Food Lion, for the participants to pick up from the store. Groceries will be ordered weekly for the 12 months of enrollment and coordinators will have access to view items purchased at Food Lion by each participant.

Interventions

Grocery intervention - unrestricted

Receives financial support in an unrestricted fashion (i.e., can use the money for whatever they need).

Grocery intervention - restricted

Receives financial support restricted to the purchase of items at a grocery store, and with monthly grocery shopping coaching from a trained nutrition expert.

Primary outcome measure

  • Change in BMI (Body Mass Index) [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

North Duke Street Pediatrics

Recruiting

Durham, North Carolina, United States, 27704

Contacts

More Information

Sponsor

Duke University

Last update posted

Jan 16, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-01-16.