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      Unpacking determinants and consequences of food insecurity for insulin resistance among people living with HIV: Conceptual framework and protocol for the NOURISH-OK study

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          Abstract

          Background:

          Over the past four decades, advances in HIV treatment have contributed to a longer life expectancy for people living with HIV (PLWH). With these gains, the prevention and management of chronic co-morbidities, such as diabetes, are now central medical care goals for this population. In the United States, food insecurity disproportionately impacts PLWH and may play a role in the development of insulin resistance through direct and indirect pathways. The Nutrition to Optimize, Understand, and Restore Insulin Sensitivity in HIV for Oklahoma (NOURISH-OK) will use a novel, multi-level, integrated framework to explore how food insecurity contributes to insulin resistance among PLWH. Specifically, it will explore how food insecurity may operate as an intermediary risk factor for insulin resistance, including potential linkages between upstream determinants of health and downstream consequences of poor diet, other behavioral risk factors, and chronic inflammation.

          Methods/design:

          This paper summarizes the protocol for the first aim of the NOURISH-OK study, which involves purposeful cross-sectional sampling of PLWH (n=500) across four levels of food insecurity to test our conceptual framework. Developed in collaboration with community stakeholders, this initial phase involves the collection of anthropometrics, fasting blood samples, non-blood biomarkers, 24-hour food recall to estimate the Dietary Inflammatory Index (DII ®) score, and survey data. A 1-month, prospective observational sub-study (total n=100; n=25 for each food security group) involves weekly 24-hour food recalls and stool samples to identify temporal associations between food insecurity, diet, and gut microbiome composition. Using structural equation modeling, we will explore how upstream risk factors, including early life events, current discrimination, and community food access, may influence food insecurity and its potential downstream impacts, including diet, other lifestyle risk behaviors, and chronic inflammation, with insulin resistance as the ultimate outcome variable. Findings from these analyses of observational data will inform the subsequent study aims, which involve qualitative exploration of significant pathways, followed by development and testing of a low-DII ® food as medicine intervention to reverse insulin resistance among PLWH ( ClinicalTrials.gov Identifier: NCT05208671).

          Discussion:

          The NOURISH-OK study will address important research gaps to inform the development of food as medicine interventions to support healthy aging for PLWH.

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          A brief measure for assessing generalized anxiety disorder: the GAD-7.

          Generalized anxiety disorder (GAD) is one of the most common mental disorders; however, there is no brief clinical measure for assessing GAD. The objective of this study was to develop a brief self-report scale to identify probable cases of GAD and evaluate its reliability and validity. A criterion-standard study was performed in 15 primary care clinics in the United States from November 2004 through June 2005. Of a total of 2740 adult patients completing a study questionnaire, 965 patients had a telephone interview with a mental health professional within 1 week. For criterion and construct validity, GAD self-report scale diagnoses were compared with independent diagnoses made by mental health professionals; functional status measures; disability days; and health care use. A 7-item anxiety scale (GAD-7) had good reliability, as well as criterion, construct, factorial, and procedural validity. A cut point was identified that optimized sensitivity (89%) and specificity (82%). Increasing scores on the scale were strongly associated with multiple domains of functional impairment (all 6 Medical Outcomes Study Short-Form General Health Survey scales and disability days). Although GAD and depression symptoms frequently co-occurred, factor analysis confirmed them as distinct dimensions. Moreover, GAD and depression symptoms had differing but independent effects on functional impairment and disability. There was good agreement between self-report and interviewer-administered versions of the scale. The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research.
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            The PHQ-9: validity of a brief depression severity measure.

            While considerable attention has focused on improving the detection of depression, assessment of severity is also important in guiding treatment decisions. Therefore, we examined the validity of a brief, new measure of depression severity. The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ-9 was completed by 6,000 patients in 8 primary care clinics and 7 obstetrics-gynecology clinics. Construct validity was assessed using the 20-item Short-Form General Health Survey, self-reported sick days and clinic visits, and symptom-related difficulty. Criterion validity was assessed against an independent structured mental health professional (MHP) interview in a sample of 580 patients. As PHQ-9 depression severity increased, there was a substantial decrease in functional status on all 6 SF-20 subscales. Also, symptom-related difficulty, sick days, and health care utilization increased. Using the MHP reinterview as the criterion standard, a PHQ-9 score > or =10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Results were similar in the primary care and obstetrics-gynecology samples. In addition to making criteria-based diagnoses of depressive disorders, the PHQ-9 is also a reliable and valid measure of depression severity. These characteristics plus its brevity make the PHQ-9 a useful clinical and research tool.
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              Reproducible, interactive, scalable and extensible microbiome data science using QIIME 2

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                Author and article information

                Journal
                9918266295306676
                50976
                Front Clin Diabetes Healthc
                Front Clin Diabetes Healthc
                Frontiers in clinical diabetes and healthcare
                2673-6616
                24 September 2022
                2022
                16 August 2022
                11 October 2022
                : 3
                : 947552
                Affiliations
                [1 ]Department of Health Promotion Sciences, Hudson College of Public Health, University of Oklahoma Tulsa Schusterman Center, Tulsa, OK, United States,
                [2 ]Department of Family and Community Medicine, University of Oklahoma School of Community Medicine, Tulsa, OK, United States,
                [3 ]Tulsa CARES, Tulsa, OK, United States,
                [4 ]Department of Biostatistics and Epidemiology, Hudson College of Public Health, University of Oklahoma Tulsa Schusterman Center, Tulsa, OK, United States,
                [5 ]Department of Psychiatry, Oklahoma State University Center for Health Sciences, Tulsa, OK, United States,
                [6 ]Center for Rural Health, Oklahoma State University Center for Health Sciences, Tulsa, OK, United States,
                [7 ]Department of Public Health, Purdue University, West Lafayette, IN, United States,
                [8 ]Department of Surgery, University of Oklahoma School of Community Medicine, Tulsa, OK, United States,
                [9 ]Department of Psychiatry, University of Oklahoma School of Community Medicine, Tulsa, OK, United States,
                [10 ]Department of Biochemistry and Microbiology, Oklahoma State University Center for Health Sciences, Tulsa, OK, United States,
                [11 ]Department of Epidemiology and Biostatistics, University of South Carolina, Columbia, SC, United States,
                [12 ]Division of HIV, Infectious Disease and Global Medicine, Department of Medicine, University of California, San Francisco (UCSF), San Francisco, CA, United States
                Author notes

                Author contributions

                MSW, conceptualized and obtained funding the NOURISH-OK study, designed the conceptual framework depicted in Figure 1, led development of the methods, and wrote the original manuscript draft; CB, contributed to the overall study design and recruitment strategies, led participant advisory board activities; LC, led project administration activities pertaining to database development, writing of research protocol, participant enrollment, data collection, and monitoring; MBW, led data curation activities pertaining to data management, cleaning and integrity and supervised statistical support staff; MLH led methods for structural equation modeling; RH, advised on recruitment methods for rural Oklahomans living with HIV; RDW, advised on rural sampling and classification methods; TKT, led selection of blood and serum laboratory measures and supervision of laboratory personnel; GK, contributed to the literature review, advised on microbiome sub-study design and oversaw analysis of oral and gut microbiome samples; JDH, co-developed the Dietary Inflammatory Index ® and advised on nutrition epidemiologic methods; SDW, advised on study design, participant safety protocols, and survey measures as an HIV food insecurity content expert. All authors reviewed, edited, and approved the final version of the manuscript.

                [* ]CORRESPONDENCE: Marianna S. Wetherill, marianna-wetherill@ 123456ouhsc.edu
                Article
                NIHMS1838437
                10.3389/fcdhc.2022.947552
                9552993
                36225538
                70a03381-075f-4aa8-bf0c-e4d5934112c8

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

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                Article

                food insecurity,food access,insulin resistance,hiv- human immunodeficiency virus,inflammation,microbiome,community-based participatory research (cbpr),structural equation modeling

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