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Food Secure Group for Food Insecurity

N/A

Waitlist Available

Research Sponsored by The Miriam Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

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
Inflammation
Childhood Obesity

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Child Mood

Child weight status

Dietary Quality

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Food Secure GroupExperimental Treatment1 Intervention

Children randomized to the Food Secure group will receive breakfast and lunch meals for eight weeks throughout the summer. Weekly meals will be delivered to each participant's home by Yumble, a company that prepares meals for children ages 3 to 12 years and ships them fresh in insulated, food safe packaging to the home. The meals have similar nutrition standards to those offered via the National School Lunch Program and include fruits, vegetables, whole grains, and lean/ vegetarian proteins. To accommodate cultural preferences or dietary constraints, Yumble offers 20 different breakfast, lunch and dinner meals each week. Families will choose their weekly menus to improve adherence. Participants who have siblings in their home will be provided a family meal kit, which provides 24 meals each week. Additional meals will help to prevent household food insecurity and ensure that the child enrolled in the study consumes the meals each week.

Group II: Food Insecure GroupActive Control1 Intervention

Children randomized to the naturally-occurring Food Insecure group will receive a weekly newsletter with information on available area-specific food programs. The weekly newsletter will be sent in two ways: 1) a paper copy will be mailed and 2) a link to an electronic version will be sent via Ilumivu to families to remove any barriers to engagement with the information. In the absence of school meal programs, children from low-income households are at increased risk for food insecurity during the summer.37-39 Given low engagement in summer food programs, it is not expected that this newsletter will impact food security in this group.

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Find a Location

Who is running the clinical trial?

The Miriam HospitalLead Sponsor

238 Previous Clinical Trials

37,466 Total Patients Enrolled

National Institute of General Medical Sciences (NIGMS)NIH

268 Previous Clinical Trials

248,751 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly persons eligible for inclusion in this clinical trial?

"This research is only open to individuals between 8 and 12 years old."

Answered by AI

Is enrollment still open in this research project?

"Affirmative. Clinicaltrials.gov data verifies that this medical trial, whose inception was on May 24th 2022, is actively seeking recruits. 100 participants must be enrolled at a singular site."

Answered by AI

Who meets the eligibility criteria for this clinical trial?

"This clinical trial requires that applicants possess adequate mental wellbeing and range between 8 to 12 years of age. In total, the study wishes to recruit 100 participants."

Answered by AI

What is the scope of the analysis for this clinical trial?

"Affirmative. As indicated by the clinicaltrials.gov database, this study is actively seeking participants who signed up since May 24th 2022 and was last amended on October 17th 2022. The trial necessitates 100 patients from a single site to enroll."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Biobehavioral Mechanisms of Food Insecurity

2022. "Biobehavioral Mechanisms of Food Insecurity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04968496.