The Fruit and Veggies for Kidney Health Study: A Prospective Randomized Trial.

Rationale & Objective: Providing fruits and vegetables (F&Vs) to health care system patients with elevated urine albumin-creatinine ratio (ACR) reduced ACR, slowed chronic kidney disease (CKD) progression and reduced cardiovascular disease (CVD) risk factors in previous studies. This study evaluated a community-based strategy in lower-income populations to identify African Americans with elevated ACR before health care system involvement and sustain them in a 6-month F&V protocol with (F&V + Cook) and without (F&V Only) cooking instructions, with the hypothesis that adjuvant cooking instructions with F&Vs would further reduce ACR. Study Design: Prospective, randomized, parallel 2-arm design. Setting & Participants: African American adults with ACR >10 mg/g creatinine randomized to 1 of 2 study arms. Interventions: Two cups/day of F&Vs with or without cooking instructions in participants followed 6 months. Outcomes: Participants sustaining the F&V protocol and between-group indicators of CVD risk, kidney injury, and dietary intake at 6 weeks and 6 months. Results: A total of 142 African American adults (mean age, 57.0 years; ACR, 27.4 mg/g; body mass index, 34.4; 24.9% CKD 1; 24.8% CKD 2; 50.4% CKD 3; 55% female) randomized to F&V Only (n=72) or F&V + Cook (n=70), and 71% were retained at 6 months. Participants received 90% of available F&V pick-ups over 6 weeks and 69% over 6 months. In the adjusted model, 6-month ACR was 31% lower for F&V + Cook than F&V Only (P = 0.02). Net 6-week F&V intake significantly increased and biometric variables improved for participants combined into a single group. Limitations: Small sample size, low-baseline ACR, and potential nonresponse bias for 24-hour dietary recall measure. Conclusions: These data support the feasibility of identifying community-dwelling African Americans with ACR indicating elevated CVD and CKD risk and sustaining a F&V protocol shown to improve kidney outcomes and CVD risk factors and provides preliminary evidence that cooking instructions adjuvant to F&Vs are needed to lower ACR. Funding: National Institute on Diabetes, Digestive, and Kidney Diseases grant "Reducing chronic kidney disease burden in an underserved population" (R21DK113440). Trial Registration: NCT03832166. Plain-Language Summary: African Americans, particularly those in low-income communities, have increased rates of chronic kidney disease (CKD) with worsening outcomes over time. Giving fruits and vegetables to individuals with CKD identified in health care systems was previously shown to reduce kidney damage, measured by urine protein albumin, and slow kidney function decline. We recruited African Americans in low-income communities with increased urine albumin levels. They received fruits and vegetables for 6 months, and we tested whether added cooking instructions further reduced urine albumin levels. Most participants continued to receive fruits and vegetables throughout the 6 months. Those given cooking instructions had lower urine albumin levels after 6 months, indicating decreased kidney damage. Providing cooking instructions with fruits and vegetables appears to lessen kidney damage more than just fruits and vegetables alone.

Community health worker navigation to improve allostatic load: The Integrated Population Health (IPOP) study.

Background: Social determinants of health (SDOH) and cumulative stress contribute to chronic disease development. The physiological response to repeated stressors typical of lower-income environments can be measured through allostatic load - a composite measure of cardiovascular, metabolic, and immune variables. Healthcare systems have employed patient navigation for social and medical needs to improve SDOH that has demonstrated limited impact on chronic disease outcomes. This study evaluates a novel community health worker navigation intervention developed using behavioral theories to improve access to social and medical services and provide social support for poverty stressed adults. Methods: The Integrated Population Health Study (IPOP) study is a randomized, parallel two arm study evaluating community health worker navigation in addition to an existing integrated population health program (IPOP CHW) as compared to Usual Care (population health program only, IPOP) on allostatic load and chronic disease risk factors. IPOP CHW participants receive a 10-month navigation intervention. Results: From 381 screened individuals, a total of 202 participants (age 58.15 ± 12.03 years, 74.75 % female, 79.21 % Black/African American, 17.33 % Hispanic) were enrolled and randomized to IPOP CHW (n = 100) or IPOP Only (n = 102). Conclusion: This study will evaluate whether CHW navigation, using a structured intervention based on health behavior theories, can effectively guide poverty stressed individuals to address social and medical needs to improve allostatic load-a composite of cumulative stress and physiological responses. Healthcare systems, nonprofit organizations, and governmental entities are interested in addressing SDOH to improve health, thus developing evidence-based interventions could have broad clinical and policy implications.

Development of a decentralized cohort for studying post-acute sequelae of COVID-19 in India in the Data4life Study.

BACKGROUND: Decentralized, digital health studies can provide real-world evidence of the lasting effects of COVID-19 on physical, socioeconomic, psychological, and social determinant factors of health in India. Existing research cohorts, however, are small and were not designed for longitudinal collection of comprehensive data from India's diverse population. Data4Life is a nationwide, digitally enabled, health research initiative to examine the post-acute sequelae of COVID-19 across individuals, communities, and regions. Data4Life seeks to build an ethnically and geographically diverse population of at least 100,000 participants in India. METHODS: Here we discuss the feasibility of developing a completely decentralized COVID-19 cohort in India through qualitative analysis of data collection procedures, participant characteristics, participant perspectives on recruitment and reported study motivation. RESULTS: As of June 13th, 2022, more than 6,000 participants from 17 Indian states completed baseline surveys. Friend and family referral were identified as the most common recruitment method (64.8%) across all demographic groups. Helping family and friends was the primary reason reported for joining the study (61.5%). CONCLUSIONS: Preliminary findings support the use of digital technology for rapid enrollment and data collection to develop large health research cohorts in India. This demonstrates the potential for expansion of digitally enabled health research in India. These findings also outline the value of person-to-person recruitment strategies when conducting digital health research in modern-day India. Qualitative analysis reveals opportunities to increase diversity and retention in real time. It also informs strategies for improving participant experiences in the current Data4Life initiative and future studies.

Due to the vast geographical size and ethnic diversity of the population, India represents a huge challenge for conducting research studies. The Data4Life study was set up to understand if digital tools can be an effective way to study long-term effects of COVID-19 across India. We studied different ways of collecting the relevant information from participants, the background of each participant, reasons, and motivation of each participant for joining the study. The results showed that friend and family referrals were the most common recruitment reason. Helping family and friends was reported as the main motivation for joining the study. Overall, the findings support the use of digital tools as an effective recruitment method for research studies in India.

Head and Neck Virtual Coach: A Randomized Control Trial of Mobile Health as an Adjunct to Swallowing Therapy During Head and Neck Radiation.

Dysphagia is a common consequence of head and neck radiation and may be mitigated by performance of swallowing exercises during radiation treatment. Given historically poor adherence to such exercise protocols, we created a mobile health application, HNC Virtual Coach as an adjunct to standard clinical care. This randomized control trial investigated the impact of HNC Virtual Coach on adherence as well as swallowing outcomes by comparing those using the mobile app to those receiving only standard clinical care and paper logs. Both treatment groups were provided with the same exercise protocol as well as the same baseline educational information. Outcome measures included adherence rates, physiologic measures obtained during a Modified Barium Swallow Study (PAS, MBS-ImP, DIGEST), patient-reported outcomes (MDADI), diet levels (FOIS, PSS-HN), and quality of information received (INFO-25). Patients using the HNC Virtual Coach tended to have better adherence to treatment recommendations during radiation therapy. Increased adherence was associated with better patient-reported quality of life, but not physiologic function 2-3 months following completion of radiation. Results suggest that a mobile health application may provide benefit for some patients undergoing head and neck radiation.

Effect of Comprehensive Multi-Provider Primary Care Visits in Type 2 Diabetes Management in a Primarily Uninsured, Ethnic Minority Population: The Comprehensive Care Initiative (CCI) Program.

The Comprehensive Care Initiative (CCI) utilized a quasi-experimental design to evaluate the effects of same room, multi-provider primary care visits on the management of type 2 diabetes (T2D). Patients with T2D were invited to enroll in CCI if they had T2D with glycated hemoglobin (HbA1c) >8.0% or T2D with BMI >30. CCI intervention included delivery of comprehensive same room multi-provider visits with a primary care physician, community health worker, pharmacist, dietitian, medical assistant, and licensed social worker at the same appointment. CCI patients were compared with a propensity score matched control group receiving usual care (n = 56, 50 ± 11 years old, 77% female, 41% African American, 95% uninsured). After 6 months, the adjusted average reduction in HbA1c in the CCI group was 0.97% (SE = 0.45) in comparison to 0.05% (SE = 0.20) in the control group (P = .04). This pilot study showed promising results in lowering HbA1c in an uninsured, ethnic minority population of T2D patients through delivery of comprehensive multi-provider primary care visits.

A population health dietary intervention for African American adults with chronic kidney disease: The Fruit and Veggies for Kidney Health randomized study.

BACKGROUND: Chronic kidney disease (CKD) is commonly asymptomatic until its late stages, reduces life quality and length, is costly to manage, and is disproportionately prevalent in low-income, African American (AA) communities. Traditional health system strategies that engage only patients with symptomatic CKD limit opportunities to prevent progression to end stage kidney disease (ESKD) with the need for expensive kidney replacement therapy and to reduce risk for their major mortality cause, cardiovascular disease (CVD). Published studies show that giving fruits and vegetables (F&V) to AA with early-stage CKD along with preparation instructions slowed CKD progression. This effective, evidenced-based, and potentially scalable dietary intervention might be a component of a community-based strategy to prevent CKD progression. DESIGN: This study supported by NIH grant (R21DK113440) will test the feasibility of an innovative screening strategy conducted at community-based institutions in low-income AA communities and the ability to intervene in individuals identified to have CKD and increased CVD risk with F&V, with or without preparation instructions. OBJECTIVES: The study will prospectively compare changes in urine indices predictive of CKD progression and CVD in participants receiving, compared to those not receiving, preparation instructions along with F&V, six months after the intervention. DISCUSSION: Addressing the challenge of increasing progression of early to more advanced stages of CKD with its increased CVD risk requires development of effective strategies to screen, identify, and intervene with individuals found to have CKD with effective, comparatively inexpensive, community-based, and scalable strategies to prevent CKD progression, particularly in low-income, AA communities.