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Biobehavioral Mechanisms of Food Insecurity

Primary Purpose

Food Insecurity, Obesity, Childhood, Inflammation

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Food Secure Group
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Food Insecurity

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Newport Housing Authority

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Food Insecure Group

Food Secure Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
Markers of Inflammation
Blood sample analyzed for C-reactive protein
Markers of Inflammation
Blood sample analyzed for interleukin-6 levels
Markers of Metabolic Syndrome
Blood sample analyzed for glucose
Markers of Metabolic Syndrome
Blood sample analyzed for hemoglobin A1c
Markers of Metabolic Syndrome
Blood sample analyzed for insulin
Markers of Stress
Blood sample analyzed for cortisol
Markers of Stress
Blood sample analyzed for leptin
Markers of Stress
Blood sample analyzed for adiponectin
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.
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.
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

Secondary Outcome Measures

Full Information

First Posted
June 15, 2021
Last Updated
January 24, 2023
Sponsor
The Miriam Hospital
Collaborators
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT04968496
Brief Title
Biobehavioral Mechanisms of Food Insecurity
Official Title
Isolating Food Insecurity to Understand Childhood Health Outcomes and Biological Mechanisms of Risk
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
The Study PI has resigned
Study Start Date
May 24, 2022 (Actual)
Primary Completion Date
August 26, 2022 (Actual)
Study Completion Date
January 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Miriam Hospital
Collaborators
National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Insecurity, Obesity, Childhood, Inflammation, Mental Health

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Food Insecure Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Food Secure Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Food Secure Group
Intervention Description
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
Primary Outcome Measure Information:
Title
Dietary Quality
Description
Healthy Eating Index (HEI 2015) - scores range from 0 to 100, with 100 representing perfect adherence to the Dietary Guidelines for Americans, 2015
Time Frame
2 months
Title
Markers of Inflammation
Description
Blood sample analyzed for C-reactive protein
Time Frame
3 months
Title
Markers of Inflammation
Description
Blood sample analyzed for interleukin-6 levels
Time Frame
3 months
Title
Markers of Metabolic Syndrome
Description
Blood sample analyzed for glucose
Time Frame
3 months
Title
Markers of Metabolic Syndrome
Description
Blood sample analyzed for hemoglobin A1c
Time Frame
3 months
Title
Markers of Metabolic Syndrome
Description
Blood sample analyzed for insulin
Time Frame
3 months
Title
Markers of Stress
Description
Blood sample analyzed for cortisol
Time Frame
3 months
Title
Markers of Stress
Description
Blood sample analyzed for leptin
Time Frame
3 months
Title
Markers of Stress
Description
Blood sample analyzed for adiponectin
Time Frame
3 months
Title
Child Mood
Description
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.
Time Frame
3 months
Title
Child Mood
Description
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.
Time Frame
3 months
Title
Child weight status
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Newport Housing Authority
City
Newport
State/Province
Rhode Island
ZIP/Postal Code
02840
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35381377
Citation
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.
Results Reference
derived

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Biobehavioral Mechanisms of Food Insecurity

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