Food Secure Group for Food Insecurity

Phase-Based Progress Estimates
Food Insecurity+3 MoreFood Secure Group - Other
8 - 12
All Sexes
What conditions do you have?

Study 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.

Eligible Conditions
  • Food Insecurity
  • Mental Health
  • Childhood Obesity
  • Inflammation

Treatment Effectiveness

Study Objectives

6 Primary · 0 Secondary · Reporting Duration: 3 months

2 months
Dietary Quality
3 months
Child Mood
Child weight status
Markers of Inflammation
Markers of Metabolic Syndrome
Markers of Stress

Trial Safety

Trial Design

2 Treatment Groups

Food Insecure Group
1 of 2
Food Secure Group
1 of 2

Active Control

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Food Secure Group · No Placebo Group · N/A

Food Secure Group
Experimental Group · 1 Intervention: Food Secure Group · Intervention Types: Other
Food Insecure GroupNoIntervention Group · 1 Intervention: Food Insecure Group · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months

Who is running the clinical trial?

The Miriam HospitalLead Sponsor
227 Previous Clinical Trials
35,909 Total Patients Enrolled
National Institute of General Medical Sciences (NIGMS)NIH
221 Previous Clinical Trials
91,042 Total Patients Enrolled

Eligibility Criteria

Age 8 - 12 · All Participants · 2 Total Inclusion Criteria

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