Current State and New Horizons in Applications of Physiologically Based Biopharmaceutics Modeling (PBBM): A Workshop Report.

This report summarizes the proceedings for Day 3 of the workshop titled "". This day focused on the current and future drug product quality applications of PBBM from the innovator and generic industries as well as the regulatory agencies perspectives. The presentations, which included several case studies, covered the applications of PBBM in generic drug product development, applications of virtual bioequivalence trials to support formulation bridging and the utility of absorption modeling in clinical pharmacology assessments.

Adding a Brief Continuous Glucose Monitoring Intervention to the National Diabetes Prevention Program: A Multimethod Feasibility Study.

The National Diabetes Prevention Program (DPP) promotes lifestyle changes to prevent diabetes. However, only one-third of DPP participants achieve weight loss goals, and changes in diet are limited. Continuous glucose monitoring (CGM) has shown potential to raise awareness about the effects of diet and activity on glucose among people with diabetes, yet the feasibility of including CGM in behavioral interventions for people with prediabetes has not been explored.

A Qualitative Study on Parenting Practices to Sustain Adolescent Health Behaviors in American Indian Families.

American Indian (AI) adolescents who practice healthy behaviors of sleep, nutrition, physical activity, and limited screen time can lower their lifetime risk of diet-sensitive disease. Little is known about how AI parenting practices influence the health behaviors of youth. The objective of this qualitative study was to explore how a group of AI parents of youths at risk of disease influenced their youth's health behaviors after a family intervention.

Feasibility of a food-based diabetes self-management education intervention for food insecure patients with type 2 diabetes: a convergent mixed methods study.

Objective: To assess the feasibility of a food-based diabetes self-management education and support (DSMES) intervention delivered to persons with type 2 diabetes (T2DM) and food insecurity.

Design: This single arm pre-/post convergent mixed methods study tested the feasibility of a 3-month intervention using food boxes, recipes, DSMES and dietitian visits. Feasibility benchmarks assessed were acceptability (> 50 % participants satisfied), demand (> 50 % used program components) and implementation (75 % adherence, 80 % retention).

Food Security is Associated with Higher Diet Quality Among Children of the US-Affiliated Pacific Region.

Background: The prevalence of food insecurity and its relationship to diet quality are factors impacting the health of persons living across the United States-affiliated Pacific region (USAP).

Objectives: The aim of this study was to describe characterize the relationship between household food security status and diet quality of 2- to 8-y-old children across jurisdictions in the USAP.

Methods: Baseline data from 2- to 8-y-olds (n = 3099) enrolled in the Children's Healthy Living Program for Remote Underserved Minority Populations in the Pacific region, an obesity prevention study conducted in communities across Alaska, American Samoa, Commonwealth of the Northern Mariana Islands (CNMI), Guam, and Hawaii, and a concomitant prevalence study in communities across the Freely Associated States (FAS) (the Federated States of Micronesia: Kosrae, Pohnpei, Chuuk, Yap; Republic of Marshall Islands; Republic of Palau) were collected in 2012.

Factors influencing adults to drop out of intensive lifestyle interventions for weight loss.

Reducing ≥5% of body weight can decrease the risk of developing chronic diseases in adults with excess weight. Although Intensive Lifestyle Interventions (ILIs) that include cognitive-behavioral techniques to improve physical activity and eating habits are the best approach for losing weight, the failure to retain participants is a barrier to their successful implementation. We aimed to investigate the factors influencing adults to drop out of ILIs for weight loss at six months.

An IQ Consortium Perspective on Connecting Dissolution Methods to In Vivo Performance: Analysis of an Industrial Database and Case Studies to Propose a Workflow.

Assessment of bioperformance to inform formulation selection and development decisions is an important aspect of drug development. There is high demand in the pharmaceutical industry to develop an efficient and streamlined approach for better understanding and predicting drug product performance to support acceleration of clinical timelines. This manuscript presents an effort from the IQ Formulation Bioperformance Prediction Working Group composed of members from 12 pharmaceutical companies under the IQ Consortium to develop a database around the topic of formulation bioperformance prediction and report findings from the database analysis.

Diet Quality Following Food Pantry Visit Differs by Ethnicity.

Food insecurity is associated with poor diet quality and increased diet-related disease risk. Food pantry clients (n=194) completed one 24-hour dietary recall and the Healthy Eating Index-2015 was used to evaluate diet quality. Differences in diet quality relative to participants' last food pantry visit and self-reported ethnicity were evaluated using two-way ANOVA.

Food Assistance Use Among Food Bank Clients Affected by Type 2 Diabetes.

Objective: To understand the perspectives of food bank clients affected by type 2 diabetes (T2DM).

Design: Semi-structured in-depth interviews conducted with food bank clients.

Setting: Arizona regional food bank.

Feasibility and Acceptability of a Type 2 Diabetes Prevention Intervention for Mothers and Children at a Federally Qualified Healthcare Center.

Background: Maternal obesity and gestational diabetes mellitus (GDM) contribute to increased risk for type 2 diabetes mellitus (T2DM) among both mothers and their offspring. Randomized trials demonstrated T2DM risk reduction in adults following lifestyle behavior change and modest weight loss; the evidence base for at-risk children remains limited.

Purpose: Evaluate the feasibility, acceptability, and preliminary efficacy of a T2DM prevention intervention for mother-child dyads delivered by Federally Qualified Health Center staff.

Struggling with the basics: food and housing insecurity among college students across twenty-two colleges and universities.

Objectives: To quantify the number and type of students failing to secure basic needs.

Participants: Students attending 22 postsecondary schools in the United States in Fall 2019.

Methods: The Adult Food Security Module and part of the #RealCollege Survey were used to measure food and housing insecurity, respectively.

Parent Involvement in Diet or Physical Activity Interventions to Treat or Prevent Childhood Obesity: An Umbrella Review.

Parents substantially influence children's diet and physical activity behaviors, which consequently impact childhood obesity risk. Given this influence of parents, the objective of this umbrella review was to synthesize evidence on effects of parent involvement in diet and physical activity treatment and prevention interventions on obesity risk among children aged 3-12 years old. Ovid/MEDLINE, Elsevier/Embase, Wiley/Cochrane Library, Clarivate/Web of Science, EBSCO/CINAHL, EBSCO/PsycInfo, and Epistemonikos.

Awareness, Knowledge, and Misperceptions Related to Nonalcoholic Fatty Liver Disease in a Community Sample of Mexican-Origin Women: A Mixed Methods Study.

Mexican-origin women suffer disproportionate rates of nonalcoholic fatty liver disease (NAFLD) and research on how to tailor NAFLD treatment interventions for this population is lacking. The purpose of this study was to assess awareness, knowledge, perceptions, and information sources related to NAFLD in a community-based sample of Mexican-origin women. This study employed a convergent parallel mixed-methods approach and consisted of a brief questionnaire ( = 194) and interviews ( = 26) among Mexican-origin women recruited from community-based settings including health fairs, churches, and community events.

Weight Loss Interventions for Hispanic Women in the United States: A Systematic Review.

Background: Obesity rates in Hispanic women residing in the United States (U.S.) are disproportionately high, increasing the risk of obesity-related disease and mortality.

Assessing Interactions between and Dietary Intake on Liver Steatosis in Mexican-Origin Adults.

Mexican-origin (MO) adults have among the highest rates of nonalcoholic fatty liver disease (NAFLD) placing them at increased risk of liver cancer. Evidence suggests that a single nucleotide polymorphism (SNP) in the gene, rs738409, increases the risk and progression of NAFLD and may modify the relationship between certain dietary factors and liver steatosis. The purpose of this study was to identify whether interactions exist between specific dietary factors and rs738409 genotype status among MO adults in relation to levels of liver steatosis.

Primary Disease Prevention for Southwest American Indian Families During the COVID-19 Pandemic: Camp in a Box.

The goal of the American Indian Youth Wellness Camp in a Box was to engage, educate and empower families to improve their health and overall well-being during the COVID-19 pandemic. Camp in a Box was a 9-week program, inclusive of a 1-week intensive camp component followed by an 8-week booster component with content focused on nutrition, mental health and physical activity education. The Camp in a Box is a Tribal/Urban Indian-University partnership, and materials were developed to replace an existing weeklong residential camp and to comply with social distancing guidelines.

College student sleep quality and mental and physical health are associated with food insecurity in a multi-campus study.

Objective: To assess the relationship between food insecurity, sleep quality, and days with mental and physical health issues among college students.

Design: An online survey was administered. Food insecurity was assessed using the ten-item Adult Food Security Survey Module.

Rationale and design of a type 2 diabetes prevention intervention for at-risk mothers and children at a Federally Qualified Healthcare Center: EPIC El Rio Families Study Protocol.

Background: Exposure to gestational diabetes mellitus (GDM) is associated with increased risk for type 2 diabetes (T2DM) in mothers, and poor cardiovascular health among offspring. Identifying effective methods to mitigate T2DM risk has the potential to improve health outcomes for mothers with a history of GDM and their children. The goal of the EPIC El Rio Families Study is to implement and evaluate the effects of a 13-week behavioral lifestyle intervention on T2DM risk factors in at-risk mothers and their 8- to 12-year-old children.

Negative Food Effect of Danirixin: Use of PBPK Modelling to Explore the Effect of Formulation and Meal Type on Clinical PK.

Purpose: To use physiologically-based pharmacokinetic (PBPK) modelling to explore the food effect of different DNX hydrobromide (HBr) hemihydrate salt tablet formulations using biorelevant dissolution.

Methods: Compendial dissolution using a paddle method and TIM-1 biorelevant dissolution were performed and incorporated into a previously reported PBPK model. A two-part clinical study evaluated tablet formulations in the fasted/fed (high fat) state (Part A), and the impact of food (fasted/normal/high fat) and Proton Pump Inhibitor (PPI) co-administration for a selected formulation; as well as a formulation containing DNX HBr in the monohydrate state (Part B).

Examining Equitable Online Federal Food Assistance during the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2): A Case Study in 2 Regions.

The USDA Supplemental Nutrition Assistance Program (SNAP) provides food and financial assistance to food-insecure individuals and families. In the midst of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, SNAP benefits evolved. Policy changes and federal legislation expanded SNAP eligibility, raised benefit levels, and introduced program waivers that enabled online ordering to reduce participants' exposure to community-acquired SARS-CoV-2.

Associations of Number of Daily Eating Occasions with Type 2 Diabetes Risk in the Women's Health Initiative Dietary Modification Trial.

Background: Over 23 million Americans have type 2 diabetes (T2D). Eating habits such as breakfast consumption, time-restricted eating, and limiting daily eating occasions have been explored as behaviors for reducing T2D risk, but prior evidence is inconclusive.

Objectives: Our objectives were to examine associations between number of daily eating occasions and T2D risk in the Women's Health Initiative Dietary Modification Trial (WHI-DM) and whether associations vary by BMI, age, or race/ethnicity.

Lifestyle and Psychosocial Patterns and Diabetes Incidence Among Women with and Without Obesity: a Prospective Latent Class Analysis.

We conducted latent class analyses to identify women with homogeneous combinations of lifestyle and behavioral variables and tested whether latent classes were prospectively associated with diabetes incidence for women with or without baseline obesity. A total of 64,710 postmenopausal women aged 50-79 years without prevalent diabetes at baseline (years 1993-1998) were followed until 2018 with a mean follow-up of 14.6 years (sd = 6.

Adapting a Family-Focused Diabetes Prevention Program for a Federally Qualified Health Center: A Qualitative Report.

Purpose: The purpose of the study was to explore the needs of high-risk Latinx/Hispanic women with a history of gestational diabetes who were patients at a Federally Qualified Health Center (FQHC) in anticipation of a future family-based program.

Methods: Six focus group studies were conducted in partnership with El Rio Community Health Center, an FQHC in Tucson, Arizona. Thirty-nine women participated, each identified as Latinx/Hispanic, self-reported a history of gestational diabetes or prediabetes, and had at least 1 child aged 8 to 13.