Food InsecurityNCT04968496
Biobehavioral Mechanisms of Food Insecurity
A study testing Food Secure Group in people with Food Insecurity and Obesity, Childhood, run by The Miriam Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity, Obesity, Childhood, Inflammation
- What is being tested?
- Food Secure Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2022to 24 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ability of parent and child to speak, read and write English or Spanish
- agreement to study participation and random assignment.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Newport Housing Authority
Newport, Rhode Island, 02840
About this study
Official title: Isolating Food Insecurity to Understand Childhood Health Outcomes and Biological Mechanisms of Risk
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.
Read the 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
- Being tested
- Food Secure Group
- Medical subject headings
- Pediatric Obesity, Inflammation, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Secure GroupOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Food Secure Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months
Markers of Inflammation
Blood sample analyzed for C-reactive protein
Measured: 3 months
Markers of Inflammation
Blood sample analyzed for interleukin-6 levels
Measured: 3 months
Markers of Metabolic Syndrome
Blood sample analyzed for glucose
Measured: 3 months
Markers of Metabolic Syndrome
Blood sample analyzed for hemoglobin A1c
Measured: 3 months
Markers of Metabolic Syndrome
Blood sample analyzed for insulin
Measured: 3 months
Markers of Stress
Blood sample analyzed for cortisol
Measured: 3 months
Markers of Stress
Blood sample analyzed for leptin
Measured: 3 months
Markers of Stress
Blood sample analyzed for adiponectin
Measured: 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.
Measured: 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.
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start24 May 2022
- Primary completion26 Aug 2022
- Study completion24 Jan 2023
Why it stopped: The Study PI has resigned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968496
- Sponsor's protocol ID
- 1773080
- Status last verified
- Oct 2022
- First submitted
- 15 Jun 2021
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35381377
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolating Food Insecurity to Understand Childhood Health Outcomes and Biological Mechanisms of Risk
- ClinicalTrials.gov ID
- NCT04968496
- Acronym / sponsor ID
- 1773080
- Conditions
- Food Insecurity, Obesity, Childhood, Inflammation, Mental Health
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Study PI has resigned
- Enrolment
- 9 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 24 May 2022 (actual)
- Primary completion
- 26 Aug 2022 (actual)
- Study completion
- 24 Jan 2023 (actual)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Food Secure GroupChildren 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ability of parent and child to speak, read and write English or Spanish
- agreement to study participation and random assignment.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food Secure GroupWeekly 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 | Other | Food Secure Group |
Primary outcome
Dietary Quality
Time frame: 2 months
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
Time frame: 3 months
Blood sample analyzed for C-reactive protein
Markers of Inflammation
Time frame: 3 months
Blood sample analyzed for interleukin-6 levels
Markers of Metabolic Syndrome
Time frame: 3 months
Blood sample analyzed for glucose
Markers of Metabolic Syndrome
Time frame: 3 months
Blood sample analyzed for hemoglobin A1c
Markers of Metabolic Syndrome
Time frame: 3 months
Blood sample analyzed for insulin
Markers of Stress
Time frame: 3 months
Blood sample analyzed for cortisol
Markers of Stress
Time frame: 3 months
Blood sample analyzed for leptin
Markers of Stress
Time frame: 3 months
Blood sample analyzed for adiponectin
Child Mood
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
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
Results and safety
The study was stopped early (reason given: The Study PI has resigned). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Derived from this study: PubMed 35381377Evans 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Secure Group in people with Food Insecurity and Obesity, Childhood, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The Study PI has resigned). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary Quality (time frame: 2 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04968496, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.