Biobehavioral Mechanisms of Food Insecurity

NCT ID: NCT04968496

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-24
• Study Completion Date: 2023-01-24

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.

Conditions

Food Insecurity; Obesity, Childhood; Inflammation; Mental Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Food Insecure Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Food Secure Group

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 Type: EXPERIMENTAL

Food Secure Group

Intervention Type: 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

Interventions

Food Secure Group

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

The Miriam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Newport Housing Authority

Newport, Rhode Island, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35381377 (View on PubMed)

Other Identifiers

1773080

Identifier Type: -

Identifier Source: org_study_id