Nutrition and Obesity in Under-Represented Populations: Food Insecurity Research to Advance Science and Improve Health

Recruiting · NCT06116422 · Interventional (participants receive a specific treatment) · Lead sponsor: Duke University

View the official record on ClinicalTrials.gov →

Interventions studied

Grocery intervention - restrictedGrocery intervention - unrestricted

What this trial is about

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.

Who can take part

Age range

12 Months to 24 Months

Sex

All (male and female)

Healthy volunteers

Yes - healthy volunteers may be accepted

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Eligibility criteria (as published)

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 is running

1 location listed across 1 US state.

North Duke Street Pediatrics - Durham, North Carolina, United States

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →