Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2025-12-16 @ 8:19 PM
Study NCT ID:
NCT04801134
Status:
None
Last Update Posted:
2021-03-23 00:00:00
First Post:
2021-03-11 00:00:00
Brief Title:
Interventions to Manage Food Insecurity and Inappropriate Feeding Practices Related to the COVID-19 Pandemic
Sponsor:
University of Texas at Austin
Organization:
University of Texas at Austin
Study Overview
Official Title:
Interventions to Manage Food Insecurity and Inappropriate Feeding Practices Related to the COVID-19 Pandemic (AMISTAD)
Status:
None
Status Verified Date:
2021-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMISTAD
Brief Summary:
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
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
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 US 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 parentchild 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 familys 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 andor 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 ie 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 cows 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 ie 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 childs medical record for nutrition-related and routinely ordered labs ie 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
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 US 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 parentchild 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 familys 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 andor 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 ie 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 cows 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 ie 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 childs medical record for nutrition-related and routinely ordered labs ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None