Clinical Trials Directory

Trials / Terminated

TerminatedNCT04968496

Biobehavioral Mechanisms of Food Insecurity

Isolating Food Insecurity to Understand Childhood Health Outcomes and Biological Mechanisms of Risk

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
9 (actual)
Sponsor
The Miriam Hospital · Academic / Other
Sex
All
Age
8 Years – 12 Years
Healthy volunteers
Accepted

Summary

Food insecurity is prevalent in the United States. Defined as unstable and inadequate access to food, food insecurity disproportionately affects low-income households, those with children and those with a Black or Hispanic head of household. Moreover, food insecurity is associated with childhood obesity, a relationship that is not well understood from a behavioral or biological perspective. This randomized controlled trial will take advantage of the natural onset of summertime food insecurity among school-age children, ages 8-12 years, to examine the biobehavioral mechanisms of food insecurity including diet quality, biomarkers of Metabolic Syndrome, inflammation, and stress, weight status, and measures of child mental health.

Detailed description

Food insecurity affects one in six households with children in the United States and disproportionately impacts those headed by women and minorities. Food insecurity is associated with childhood obesity, asthma, anxiety and depression and behavioral problems, and thus contributes to health disparities. While food insecurity likely contributes to poor health through its effect on diet, such a simplistic understanding likely obscures the effects of stress - those unique to childhood, such as Adverse Childhood Experiences including maternal depression, as well as those generally associated with the experience of poverty. To inform the mechanisms by which food insecurity ultimately affects physical and mental health outcomes in children, this study will disentangle the effects of food insecurity from those of poverty and examine effects on diet, biomarkers, weight gain, mood and behavior while considering other childhood adversities. Specifically, through a unique summertime meal provision intervention, the proposed project will isolate the experience of food insecurity in children, ages 8 to12 years, from low-income households in Providence, RI. In partnership with the YMCA of Greater Providence and the Healthy Communities Office in Providence, we will recruit 100 children over two summers. After completing a baseline assessment, participants will be randomized to receive home-delivered meals throughout the summer or to receive a weekly newsletter. Children randomized to the newsletter group will experience the natural onset of summertime food insecurity and receive a weekly newsletter on community resources that is not expected to affect food insecurity (Food Insecure Group). Those randomized to receive meals will remain food secure over the summer through receipt of weekly shipments of five breakfast and lunch meals that meet the nutrition needs of this age group (Food Secure Group). Primary endpoints include diet quality, biomarkers of Metabolic Syndrome, inflammation, and stress, BMI z-scores, and child measures of behavior and anxiety and depression symptoms. The impact of caregiver mood and stress on the health effects of food insecurity will also be explored. Ultimately, findings from this research will clarify the mechanisms by which food insecurity affects child health outcomes and inform how to more effectively prevent food insecurity.

Conditions

Interventions

TypeNameDescription
OTHERFood Secure GroupWeekly meals (five breakfast and five lunch meals) will be provided to all children randomized to this group to prevent the onset of summertime food insecurity

Timeline

Start date
2022-05-24
Primary completion
2022-08-26
Completion
2023-01-24
First posted
2021-07-20
Last updated
2023-01-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04968496. Inclusion in this directory is not an endorsement.