Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04968496 |
| Other study ID # |
1773080 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 24, 2022 |
| Est. completion date |
January 24, 2023 |
Study information
| Verified date |
October 2022 |
| Source |
The Miriam Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
