NCT04968496

Biobehavioral Mechanisms of Food Insecurity

Terminated NA Last updated 26 January 2023

What this trial tests

NA trial testing Food Secure Group in Food Insecurity in 9 participants. Terminated before completion.

Timeline

24 May 2022

Primary endpoint
26 August 2022

24 January 2023

Quick facts

Lead sponsor	The Miriam Hospital
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	9
Start date	24 May 2022
Primary completion	26 August 2022
Estimated completion	24 January 2023
Sites	1 location across United States

Drugs / interventions tested

• Food Secure Group

Conditions studied

• Food Insecurity — all drugs for Food Insecurity →
• Obesity, Childhood — all drugs for Obesity, Childhood →
• Inflammation — all drugs for Inflammation →
• Mental Health — all drugs for Mental Health →

Sponsor

The Miriam Hospital

Who can join

Adults 8 to 12, any sex, with Food Insecurity or Obesity, Childhood. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Design of a clinical trial to isolate the experience of food insecurity and elucidate the biological mechanisms of risk for childhood health outcomes.
   Evans EW, Jelalian E, Dunsiger S, Villalta D, et al · · 2022 · PMID 35381377 · DOI 10.1016/j.cct.2022.106751