Clinical trial NCT06116422: Nutrition and Obesity in Under-Represented Populations: Food Insecurity Research to Advance Science and Improve Health
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Obesity
Food Insecurity
Nutrition, Healthy
Nutrition Poor
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 228
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparative effectiveness study.
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Change in BMI (Body Mass Index)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
measure: Change in Food Security
timeFrame: baseline, 3, 6, 9 and 12 months
measure: Change in Infant Dietary Quality
timeFrame: baseline, 6 months, and 12 months
measure: Change in Unmet social needs
timeFrame: baseline, 6 months, and 12 months
measure: Perceived stress scale
timeFrame: baseline, 6 months, and 12 months
Locations:
city: Durham
country: United States
facility: North Duke Street Pediatrics
state: North Carolina
Study officials:
References: