Clinical trial NCT04968496: Biobehavioral Mechanisms of Food Insecurity
Official title: Isolating Food Insecurity to Understand Childhood Health Outcomes and Biological Mechanisms of Risk
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Food Insecurity
Obesity, Childhood
Inflammation
Mental Health
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2021-07-20
Enrollment: 9
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* ability of parent and child to speak, read and write English or Spanish
* agreement to study participation and random assignment.

Exclusion Criteria:

* Children will not be eligible if they are enrolled in a full-time camp, day care or programming in which regular meals are provided for more than one-week over the summer.
* Children will not be eligible if their Parent / caregiver does not have reliable phone access to complete study measures.

Primary outcomes:
measure: Dietary Quality
timeFrame: 2 months
measure: Markers of Inflammation
timeFrame: 3 months
measure: Markers of Inflammation
timeFrame: 3 months
measure: Markers of Metabolic Syndrome
timeFrame: 3 months
measure: Markers of Metabolic Syndrome
timeFrame: 3 months
measure: Markers of Metabolic Syndrome
timeFrame: 3 months
measure: Markers of Stress
timeFrame: 3 months
measure: Markers of Stress
timeFrame: 3 months
measure: Markers of Stress
timeFrame: 3 months
measure: Child Mood
timeFrame: 3 months
measure: Child Mood
timeFrame: 3 months
measure: Child weight status
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Newport
country: United States
facility: Newport Housing Authority
state: Rhode Island
Study officials:
References:
citation: Evans EW, Jelalian E, Dunsiger S, Villalta D, Tyrka A. Design of a clinical trial to isolate the experience of food insecurity and elucidate the biological mechanisms of risk for childhood health outcomes. Contemp Clin Trials. 2022 Jun;117:106751. doi: 10.1016/j.cct.2022.106751. Epub 2022 Apr 2.