Biobehavioral Mechanisms of Food Insecurity

NCT04968496 | Terminated

• 1 other identifier: 1773080
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Insecurity; Obesity, Childhood; Inflammation; Mental Health

Outcome Measures

Primary Outcomes (12)

• Dietary Quality

  Healthy Eating Index (HEI 2015) - scores range from 0 to 100, with 100 representing perfect adherence to the Dietary Guidelines for Americans, 2015

  2 months

• Markers of Inflammation

  Blood sample analyzed for C-reactive protein

  3 months

• Markers of Inflammation

  Blood sample analyzed for interleukin-6 levels

  3 months

• Markers of Metabolic Syndrome

  Blood sample analyzed for glucose

  3 months

• Markers of Metabolic Syndrome

  Blood sample analyzed for hemoglobin A1c

  3 months

• Markers of Metabolic Syndrome

  Blood sample analyzed for insulin

  3 months

• Markers of Stress

  Blood sample analyzed for cortisol

  3 months

• Markers of Stress

  Blood sample analyzed for leptin

  3 months

• Markers of Stress

  Blood sample analyzed for adiponectin

  3 months

• Child Mood

  PROMIS (Patient-Reported Outcomes Measurement Information System) short-form measures for assessing anxiety in children. Scores range from 10 to 50 with a higher score indicating greater anxiety symptoms.

  3 months

• Child Mood

  PROMIS (Patient-Reported Outcomes Measurement Information System) short-form measures for assessing depression in children. Scores range from 0 to 32 with a higher score indicating greater depressive symptoms.

  3 months

• Child weight status

  Body Mass Index z-score (BMIz) - Z-score will be determined based on child's BMIz for age and sex using the CDC growth charts

  3 months

Study Arms (2)

Food Insecure Group

NO 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.

Food Secure Group

EXPERIMENTAL

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.

Other: Food Secure Group

Interventions

Food Secure Group OTHER

Weekly 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

Food Secure Group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Miriam Hospital: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Newport Housing Authority

Newport, Rhode Island, 02840, United States

Location

Related Publications (1)

• 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.

  PMID: 35381377 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Inflammation; Psychological Well-Being

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: July 20, 2021
• Study Start: May 24, 2022
• Primary Completion: August 26, 2022
• Study Completion: January 24, 2023
• Last Updated: January 26, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)