North Duke Street Pediatrics
Durham, North Carolina, 27704, United States
Location status: Recruiting
NCT Number: NCT06116422
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.
Interested in participating?
Request Info12 month–24 month
All sexes
Interventional
Not applicable
Durham, North Carolina, 27704, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion:
Exclusion:
Receives financial support in an unrestricted fashion (i.e., can use the money for whatever they need).
Receives financial support restricted to the purchase of items at a grocery store, and with monthly grocery shopping coaching from a trained nutrition expert.
Time frame: 1 year
At 12 months post-enrollment (24 months of age).
Time frame: baseline, 3, 6, 9 and 12 months
As measured by an 18 item food insecurity screen to assess food insecurity levels.
Time frame: baseline, 6 months, and 12 months
As measured by the USDA multipass food recall tool (ASA24).
Time frame: baseline, 6 months, and 12 months
Changes in social determinants of health affecting the family as measured by the HealthLeads questionnaire.
Time frame: baseline, 6 months, and 12 months
As measured by a 10 item perceived stress scale for parents.
Contact information is provided by the study sponsor or research team.
Janna Howard, MPH
CONTACT
Steph Bryant, MPH, RD
CONTACT
Duke University
Other
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
Acronym: NOURISH
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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