Food InsecurityAMISTADNCT04801134
Interventions to Manage Food Insecurity and Inappropriate Feeding Practices Related to the COVID-19 Pandemic
A study testing Education in people with Food Insecurity and Children, Only, run by University of Texas at Austin at 1 site in United States.
Trial summary
This is a pilot study to determine how to identify and characterize effective approaches to assist Hispanic families who face food insecurity worsened by the Covid-19 pandemic. The investigators will enroll 50 children with food insecurity who are patients of the largest Federally Qualified Health Center in Austin… Read more about this study
- Who is it for?
- Ages Up to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity, Children, Only, Covid19
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2021to 30 May 2022
- 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 Up to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Hispanic children, established patients of 2 participating CommUnityCare Clinics (FQHC) in Austin, TX, families that screened positive for food insecurity.
Who cannot join
- non-Hispanic children, families that screen negative for food insecurity, patients that do not receive medical care at the participating CommUnityCare clinics
Trial locations and contacts
1 site in 1 country.
United States1 site
CommUnityCare Health Center
Austin, Texas, 78753 and 78741
Ana Avalos, MD, 512-978-9600, ana.avalos@austin.utexas.edu
Steven Abrams, MD, (512) 495-4700, sabrams@austin.utexas.edu
About this study
Official title: Interventions to Manage Food Insecurity and Inappropriate Feeding Practices Related to the COVID-19 Pandemic (AMISTAD)
This is a pilot study to determine how to identify and characterize effective approaches to assist Hispanic families who face food insecurity worsened by the Covid-19 pandemic. The investigators will enroll 50 children with food insecurity who are patients of the largest Federally Qualified Health Center in Austin, Texas. The investigators will follow them for 6 months, providing their caretakers with community resources, food literacy education and assisting them with web sites and applications that they can use to learn about and contact community assistance programs. The investigators will review food insecurity screening, qualitative interviews, dietary assessments, the child's anthropometrics, and standard of care laboratory results. The investigators will schedule follow up phone visits throughout the study to discuss with the families their needs and perceived assistance from the resources provided.
Read the detailed description
The investigators propose to assess food insecurity and inappropriate feeding practices within a public health clinic patient population that has at least one child less than 2 years of age at home. A targeted intervention will determine whether focused family interactions with referral and follow-up to community agencies can mitigate the frequency and effects of food insecurity on children over a six-month period. Specifically, the investigators will identify 50 Hispanic families with food insecurity based on a full screen (the investigators expect to screen 150 families).
There are 2 in-person visits for this study, both of which are routine clinic visits where the child would be seen regardless of participation in this research study. The first visit at baseline will be when the subject is approached about the study and enrolled. The second visit will also be at a routine pediatric visit for medical care follow-up approximately 6 months later. Between in-person visits, phone calls for follow-up will take place.
The investigators will use a highly validated U.S. Department of Agriculture six-question, five-minute screening tool at each pediatric visit, via telehealth or in person. Those who screen as positive for food insecurity and consent to participate will be enrolled. Subjects will be enrolled as a parent/child dyad. The validated food-insecurity questionnaire will be completed at baseline, 3 months, and 6 months. The American Academy of Pediatrics recommends to screen for food insecurity as a standard of care.
Resources When appropriate, specific referrals will be made by the study personnel (PIs who are pediatricians) to food assistance programs including Good Apple, a local fresh produce delivery program, United Way of Central Texas, and local food banks. The participants will receive a call from the study coordinator who will review the family circumstances and plan for intervention with these partner programs and follow-up. A research team member will contact our food assistance partners to confirm each family's participation. The investigators will also confirm participation when available in WIC and SNAP programs. Partner organizations will provide financial data regarding the interventions they provide, which will be analyzed and interpreted within the context of families' participation in public programs such as WIC and SNAP. The study coordinator or designee who are part of the research study team will call the families frequently (weekly for first month, then every 2 weeks until 3 months, then monthly from 3-6 months; about 12-15 calls total) to check on their progress with the food assistance programs.
The participants will receive assistance with finding useful community resources websites and/or applications, grocery shopping lists, tips for shopping on a budget, and more topics related to nutrition, wellness, food assistance programs, food banks, bus routes, mindfulness, meal planning, and parenting strategies. Along with the referral resources, these documents and apps (i.e., My Fitness Pal food tracker, Pacer fitness tracker) will help the participants improve food literacy. Providing resources when a family is identified as food insecure is standard of care. However, the electronic resources and ongoing follow up are only related to this study. The investigators will track if the participants access the electronic resources that the investigators provide.
Education and Food Literacy Families will receive education about appropriate feeding practices with emphasis on not over-diluting infant formula and appropriate introduction of cow's milk, juice and solid foods.
Education for improving food literacy will focus on the following four dimensions from budgeting and planning, to food selection, to preparation and cooking, to eating.
Dietary Assessment Due to the relationship between dietary intake and overall health, dietary assessment tools are helpful to evaluate what a person is eating and how it may have an impact, either positive or negative, on their health. The participant will be asked to provide a 24-hour nutrition intake recall (describing types and amounts of foods and drinks they consumed the previous day) for themselves and their child. The study dietitian or designee will analyze the food records with nutrition software (i.e., NDSR) for macronutrient and macronutrient breakdown. Dietary intake will be assessed at baseline and after six months using a validated questionnaire. This information will be helpful to see how dietary intakes potentially change after enrollment and participation in community resources, and to see how dietary intakes affect growth in children.
Growth and Labs The investigators will compare growth measurements (weight, height or length, and head circumference) and dietary intakes of participating children at the start and after six months. In addition, the investigators will abstract data from the child's medical record for nutrition-related and routinely ordered labs (i.e., hemoglobin, lead level). These anthropometrics and laboratories are obtained as standard of care. Hemoglobin and lead levels usually are obtained at 1 and 2 years of age. Children screening out as iron deficient or with elevated lead levels will be managed by their pediatrician according to current American Academy of Pediatrics and Texas Department of Public Health guidelines.
Qualitative Interviews Qualitative interviews will be conducted in person or by phone at baseline and after three and six months to evaluate issues of concern such as child care, transportation and loss of employment. Qualitative interviews, pertaining to this study, will include asking participants which resources they found to be most useful, ease of navigating the resources, and their overall interactions with the partner organizations. All subjects will participate in the main (shorter) qualitative interview. Fifteen (15) subjects will be asked to participate in a longer qualitative interview, that the investigators expect to take an additional 30-60 minutes. These subjects will receive additional compensation for their time.
Standard of Care • Food insecurity screening, provision of referrals and resources to family, anthropometrics, labs, education
Research Activities
- Qualitative interviews, depression screen PHQ), anxiety screen (GAD), dietary assessment, follow-up with family to discuss their participation with referrals and resources
Our objectives are:
- To identify and characterize Hispanic families who face food insecurity that occurred or worsened as a result of the current pandemic
- To identify and characterize effective approaches to assisting families with inappropriate feeding practices, especially those related to infant formula preparation
- To gain information regarding the types of resources that are most useful for planning purposes related to future pandemics or related public health crises
- To define gaps in the process of obtaining and using available community resources
- To provide baseline data regarding families and interventions so as to plan a larger-scale community-based assessment and intervention program
- Conditions
- Food Insecurity, Children, Only, Covid19
- Being tested
- Education
- Keywords
- Food Insecurity, COVID-19, Hispanic Children
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Also called Community Resources
as per previous description
| Study group | Role | What they receive |
|---|---|---|
| Food insecurity | Other | Food insecure families will be assigned education and community resources needed. Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with mitigation of food insecurity as assessed by the "Six-item short form of the Household Food Security Scale", a validated 6 item food insecurity screening tool.
Mitigate food insecurity in participating families by providing education, community resources connections and close and frequent follow ups. Food insecurity will be assessed by the 6 item validated food insecurity screen periodically. The score is a sum of affirmative responses. Two or more affirmative responses indicate food insecurity; 5 or more affirmatives indicate hunger. (citation PMID 10432912)
Measured: 6 months
Secondary outcomes (2)
Types of community resources perceived as most helpful by the participants as assessed by a qualitative questionnaire.
Assess the benefits of various resources provided including electronic websites and applications, determining those resources that are most useful. This will be asked as an open question. Questionnaire is qualitative and therefore will not be scored.
Measured: 6 months
Types of barriers to obtain assistance to alleviate food insecurity perceived by the participants as assessed by a qualitative questionnaire.
Identify any gaps or barriers in accessing the community resources. This will be asked as an open question. Questionnaire is qualitative and therefore will not be scored.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start22 Mar 2021 (estimated)
- Primary completion22 Mar 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 50 families will be followed over 6 months, providing nutrition education and support with community resources to mitigate the families food insecurity.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Perrigo Company
- Responsible party
- Sponsor
- Investigators
- Steven Abrams, MD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801134
- Sponsor's protocol ID
- HRP-UT901
- Acronym
- AMISTAD
- Status last verified
- Mar 2021
- First submitted
- 11 Mar 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient information may be shared with the study sponsor and/or representative of the sponsor; representatives of UT Austin and the UT Austin Institutional Review Board; Other collaborating organizations (Good Apple, United Way of Central Texas, local food banks, WIC, SNAP). However, we will not share the subjects' data or samples with other researchers for future research studies.
Publications
Blumberg SJ, Bialostosky K, Hamilton WL, Briefel RR. The effectiveness of a short form of the Household Food Security Scale. Am J Public Health. 1999 Aug;89(8):1231-4. doi: 10.2105/ajph.89.8.1231.
PubMed 10432912Shi Q, Castillo F, Viswanathan K, Kupferman F, MacDermid JC. Facilitators and Barriers to Access to Pediatric Medical Services in a Community Hospital. J Prim Care Community Health. 2020 Jan-Dec;11:2150132720904518. doi: 10.1177/2150132720904518.
PubMed 31997703Peltz A, Garg A. Food Insecurity and Health Care Use. Pediatrics. 2019 Oct;144(4):e20190347. doi: 10.1542/peds.2019-0347. Epub 2019 Sep 9.
PubMed 31501238COUNCIL ON COMMUNITY PEDIATRICS; COMMITTEE ON NUTRITION. Promoting Food Security for All Children. Pediatrics. 2015 Nov;136(5):e1431-8. doi: 10.1542/peds.2015-3301.
PubMed 26498462Nicola M, Alsafi Z, Sohrabi C, Kerwan A, Al-Jabir A, Iosifidis C, Agha M, Agha R. The socio-economic implications of the coronavirus pandemic (COVID-19): A review. Int J Surg. 2020 Jun;78:185-193. doi: 10.1016/j.ijsu.2020.04.018. Epub 2020 Apr 17.
PubMed 32305533Keenan DP, Olson C, Hersey JC, Parmer SM. Measures of food insecurity/security. J Nutr Educ. 2001;33 Suppl 1:S49-58. doi: 10.1016/s1499-4046(06)60069-9.
PubMed 12857544Kaiser LL, Melgar-Quinonez H, Townsend MS, Nicholson Y, Fujii ML, Martin AC, Lamp CL. Food insecurity and food supplies in Latino households with young children. J Nutr Educ Behav. 2003 May-Jun;35(3):148-53. doi: 10.1016/s1499-4046(06)60199-1.
PubMed 12773286Matheson DM, Varady J, Varady A, Killen JD. Household food security and nutritional status of Hispanic children in the fifth grade. Am J Clin Nutr. 2002 Jul;76(1):210-7. doi: 10.1093/ajcn/76.1.210.
PubMed 12081837
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Manage Food Insecurity and Inappropriate Feeding Practices Related to the COVID-19 Pandemic (AMISTAD)
- ClinicalTrials.gov ID
- NCT04801134
- Acronym / sponsor ID
- AMISTAD / HRP-UT901
- Conditions
- Food Insecurity, Children, Only, Covid19
- Keywords
- Food Insecurity, COVID-19, Hispanic Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Perrigo Company
- Study start
- 22 Mar 2021 (estimated)
- Primary completion
- 22 Mar 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 16 Mar 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.
This is a pilot study to determine how to identify and characterize effective approaches to assist Hispanic families who face food insecurity worsened by the Covid-19 pandemic. The investigators will enroll 50 children with food insecurity who are patients of the largest Federally Qualified Health Center in Austin, Texas. The investigators will follow them for 6 months, providing their caretakers with community resources, food literacy education and assisting them with web sites and applications that they can use to learn about and contact community assistance programs. The investigators will review food insecurity screening, qualitative interviews, dietary assessments, the child's anthropometrics, and standard of care laboratory results. The investigators will schedule follow up phone visits throughout the study to discuss with the families their needs and perceived assistance from the resources provided.
Detailed description
The investigators propose to assess food insecurity and inappropriate feeding practices within a public health clinic patient population that has at least one child less than 2 years of age at home. A targeted intervention will determine whether focused family interactions with referral and follow-up to community agencies can mitigate the frequency and effects of food insecurity on children over a six-month period. Specifically, the investigators will identify 50 Hispanic families with food insecurity based on a full screen (the investigators expect to screen 150 families).
There are 2 in-person visits for this study, both of which are routine clinic visits where the child would be seen regardless of participation in this research study. The first visit at baseline will be when the subject is approached about the study and enrolled. The second visit will also be at a routine pediatric visit for medical care follow-up approximately 6 months later. Between in-person visits, phone calls for follow-up will take place.
The investigators will use a highly validated U.S. Department of Agriculture six-question, five-minute screening tool at each pediatric visit, via telehealth or in person. Those who screen as positive for food insecurity and consent to participate will be enrolled. Subjects will be enrolled as a parent/child dyad. The validated food-insecurity questionnaire will be completed at baseline, 3 months, and 6 months. The American Academy of Pediatrics recommends to screen for food insecurity as a standard of care.
Resources When appropriate, specific referrals will be made by the study personnel (PIs who are pediatricians) to food assistance programs including Good Apple, a local fresh produce delivery program, United Way of Central Texas, and local food banks. The participants will receive a call from the study coordinator who will review the family circumstances and plan for intervention with these partner programs and follow-up. A research team member will contact our food assistance partners to confirm each family's participation. The investigators will also confirm participation when available in WIC and SNAP programs. Partner organizations will provide financial data regarding the interventions they provide, which will be analyzed and interpreted within the context of families' participation in public programs such as WIC and SNAP. The study coordinator or designee who are part of the research study team will call the families frequently (weekly for first month, then every 2 weeks until 3 months, then monthly from 3-6 months; about 12-15 calls total) to check on their progress with the food assistance programs.
The participants will receive assistance with finding useful community resources websites and/or applications, grocery shopping lists, tips for shopping on a budget, and more topics related to nutrition, wellness, food assistance programs, food banks, bus routes, mindfulness, meal planning, and parenting strategies. Along with the referral resources, these documents and apps (i.e., My Fitness Pal food tracker, Pacer fitness tracker) will help the participants improve food literacy. Providing resources when a family is identified as food insecure is standard of care. However, the electronic resources and ongoing follow up are only related to this study. The investigators will track if the participants access the electronic resources that the investigators provide.
Education and Food Literacy Families will receive education about appropriate feeding practices with emphasis on not over-diluting infant formula and appropriate introduction of cow's milk, juice and solid foods.
Education for improving food literacy will focus on the following four dimensions from budgeting and planning, to food selection, to preparation and cooking, to eating.
Dietary Assessment Due to the relationship between dietary intake and overall health, dietary assessment tools are helpful to evaluate what a person is eating and how it may have an impact, either positive or negative, on their health. The participant will be asked to provide a 24-hour nutrition intake recall (describing types and amounts of foods and drinks they consumed the previous day) for themselves and their child. The study dietitian or designee will analyze the food records with nutrition software (i.e., NDSR) for macronutrient and macronutrient breakdown. Dietary intake will be assessed at baseline and after six months using a validated questionnaire. This information will be helpful to see how dietary intakes potentially change after enrollment and participation in community resources, and to see how dietary intakes affect growth in children.
Growth and Labs The investigators will compare growth measurements (weight, height or length, and head circumference) and dietary intakes of participating children at the start and after six months. In addition, the investigators will abstract data from the child's medical record for nutrition-related and routinely ordered labs (i.e., hemoglobin, lead level). These anthropometrics and laboratories are obtained as standard of care. Hemoglobin and lead levels usually are obtained at 1 and 2 years of age. Children screening out as iron deficient or with elevated lead levels will be managed by their pediatrician according to current American Academy of Pediatrics and Texas Department of Public Health guidelines.
Qualitative Interviews Qualitative interviews will be conducted in person or by phone at baseline and after three and six months to evaluate issues of concern such as child care, transportation and loss of employment. Qualitative interviews, pertaining to this study, will include asking participants which resources they found to be most useful, ease of navigating the resources, and their overall interactions with the partner organizations. All subjects will participate in the main (shorter) qualitative interview. Fifteen (15) subjects will be asked to participate in a longer qualitative interview, that the investigators expect to take an additional 30-60 minutes. These subjects will receive additional compensation for their time.
Standard of Care • Food insecurity screening, provision of referrals and resources to family, anthropometrics, labs, education
Research Activities
- Qualitative interviews, depression screen PHQ), anxiety screen (GAD), dietary assessment, follow-up with family to discuss their participation with referrals and resources
Our objectives are:
- To identify and characterize Hispanic families who face food insecurity that occurred or worsened as a result of the current pandemic
- To identify and characterize effective approaches to assisting families with inappropriate feeding practices, especially those related to infant formula preparation
- To gain information regarding the types of resources that are most useful for planning purposes related to future pandemics or related public health crises
- To define gaps in the process of obtaining and using available community resources
- To provide baseline data regarding families and interventions so as to plan a larger-scale community-based assessment and intervention program
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 50 families will be followed over 6 months, providing nutrition education and support with community resources to mitigate the families food insecurity.
| Arm | Type | Receives |
|---|---|---|
| Food insecurity | Other | Other: EducationFood insecure families will be assigned education and community resources needed. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Hispanic children, established patients of 2 participating CommUnityCare Clinics (FQHC) in Austin, TX, families that screened positive for food insecurity.
Key exclusion criteria (1 listed)
- non-Hispanic children, families that screen negative for food insecurity, patients that do not receive medical care at the participating CommUnityCare clinics
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 |
|---|---|---|
| EducationAlso: Community Resourcesas per previous description | Other | Food insecurity |
Primary outcome
Number of participants with mitigation of food insecurity as assessed by the "Six-item short form of the Household Food Security Scale", a validated 6 item food insecurity screening tool.
Time frame: 6 months
Mitigate food insecurity in participating families by providing education, community resources connections and close and frequent follow ups. Food insecurity will be assessed by the 6 item validated food insecurity screen periodically. The score is a sum of affirmative responses. Two or more affirmative responses indicate food insecurity; 5 or more affirmatives indicate hunger. (citation PMID 10432912)
2 secondary outcomes
Types of community resources perceived as most helpful by the participants as assessed by a qualitative questionnaire.
Time frame: 6 months
Types of barriers to obtain assistance to alleviate food insecurity perceived by the participants as assessed by a qualitative questionnaire.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Background: PubMed 10432912Blumberg SJ, Bialostosky K, Hamilton WL, Briefel RR. The effectiveness of a short form of the Household Food Security Scale. Am J Public Health. 1999 Aug;89(8):1231-4. doi: 10.2105/ajph.89.8.1231.
- Results publication: PubMed 31997703Shi Q, Castillo F, Viswanathan K, Kupferman F, MacDermid JC. Facilitators and Barriers to Access to Pediatric Medical Services in a Community Hospital. J Prim Care Community Health. 2020 Jan-Dec;11:2150132720904518. doi: 10.1177/2150132720904518.
- Results publication: PubMed 31501238Peltz A, Garg A. Food Insecurity and Health Care Use. Pediatrics. 2019 Oct;144(4):e20190347. doi: 10.1542/peds.2019-0347. Epub 2019 Sep 9.
- Results publication: PubMed 26498462COUNCIL ON COMMUNITY PEDIATRICS; COMMITTEE ON NUTRITION. Promoting Food Security for All Children. Pediatrics. 2015 Nov;136(5):e1431-8. doi: 10.1542/peds.2015-3301.
- Results publication: PubMed 32305533Nicola M, Alsafi Z, Sohrabi C, Kerwan A, Al-Jabir A, Iosifidis C, Agha M, Agha R. The socio-economic implications of the coronavirus pandemic (COVID-19): A review. Int J Surg. 2020 Jun;78:185-193. doi: 10.1016/j.ijsu.2020.04.018. Epub 2020 Apr 17.
- Results publication: PubMed 12857544Keenan DP, Olson C, Hersey JC, Parmer SM. Measures of food insecurity/security. J Nutr Educ. 2001;33 Suppl 1:S49-58. doi: 10.1016/s1499-4046(06)60069-9.
- Results publication: PubMed 12773286Kaiser LL, Melgar-Quinonez H, Townsend MS, Nicholson Y, Fujii ML, Martin AC, Lamp CL. Food insecurity and food supplies in Latino households with young children. J Nutr Educ Behav. 2003 May-Jun;35(3):148-53. doi: 10.1016/s1499-4046(06)60199-1.
- Results publication: PubMed 12081837Matheson DM, Varady J, Varady A, Killen JD. Household food security and nutritional status of Hispanic children in the fifth grade. Am J Clin Nutr. 2002 Jul;76(1):210-7. doi: 10.1093/ajcn/76.1.210.
- Map the Meal Gap is an annual study designed to improve the understanding of food insecurity and food costs at a local levelLink provided by the sponsor.
- information on food and nutrition assistance program/USDALink provided by the sponsor.
- Individual participant dataSharing planned: No. Patient information may be shared with the study sponsor and/or representative of the sponsor; representatives of UT Austin and the UT Austin Institutional Review Board; Other collaborating organizations (Good Apple, United Way of Central Texas, local food banks, WIC, SNAP). However, we will not share the subjects' data or samples with other researchers for future research studies.
Related trials for Food Insecurity
Recruiting
Developing a Support Application for Food Pantries (SAFPAS) to Improve Client Access to Healthy Foods & Enhance Emergency Preparedness
Improving Healthy Food Access in Food Insecurity Populations in Normal and Emergency Situations
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
Not yet recruitingObservational study
Addressing Food Insecurity in Pregnancy
Food Insecurity, Pregnancy
Active, not recruiting
Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
Nutrition, Type 2 Diabetes
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.
Steven Abrams, MD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Food Insecurity and Children, Only, run by University of Texas at Austin 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Avalos, MD ((512) 502-2347, ana.avalos@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with mitigation of food insecurity as assessed by the "Six-item short form of the Household Food Security Scale", a validated 6 item food insecurity screening tool. (time frame: 6 months). 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 NCT04801134, which also lists 8 linked publications.
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 23 Mar 2021.