Clinical trial NCT04801134: Interventions to Manage Food Insecurity and Inappropriate Feeding Practices Related to the COVID-19 Pandemic
Official title: Interventions to Manage Food Insecurity and Inappropriate Feeding Practices Related to the COVID-19 Pandemic (AMISTAD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Food Insecurity
Children, Only
Covid19
Keywords: Food Insecurity
COVID-19
Hispanic Children
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Perrigo Company
First posted: 2021-03-16
Enrollment: 50
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 50 families will be followed over 6 months, providing nutrition education and support with community resources to mitigate the families food insecurity.
Primary purpose: SUPPORTIVE_CARE

Brief 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, 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:

1. To identify and characterize Hispanic families who face food insecurity that occurred or worsened as a result of the current pandemic
2. To identify and characterize effective approaches to assisting families with inappropriate feeding practices, especially those related to infant formula preparation
3. To gain information regarding the types of resources that are most useful for planning purposes related to future pandemics or related public health crises
4. To define gaps in the process of obtaining and using available community resources
5. To provide baseline data regarding families and interventions so as to plan a larger-scale community-based assessment and intervention program

Eligibility criteria: Inclusion Criteria:

* Hispanic children, established patients of 2 participating CommUnityCare Clinics (FQHC) in Austin, TX, families that screened positive for food insecurity.

Exclusion Criteria:

* non-Hispanic children, families that screen negative for food insecurity, patients that do not receive medical care at the participating CommUnityCare clinics

Primary outcomes:
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.
timeFrame: 6 months
Secondary outcomes:
measure: Types of community resources perceived as most helpful by the participants as assessed by a qualitative questionnaire.
timeFrame: 6 months
measure: Types of barriers to obtain assistance to alleviate food insecurity perceived by the participants as assessed by a qualitative questionnaire.
timeFrame: 6 months
Other outcomes:
measure: Number of participants treated with intervention without evidence of impaired growth rate as measured in infantometer (length) and digital scale (weight).
timeFrame: 6 months
measure: Number of participants treated with intervention with evidence of impaired growth rate
timeFrame: 6 months
Locations:
city: Austin
country: United States
facility: CommUnityCare Health Center
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Steven Abrams, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Kaiser 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.
citation: Matheson 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.