Revisiting development strategy under climate uncertainty: case study of Malawi.

This paper analyzes the effectiveness of agriculture-led versus non-agriculture-led development strategies under climate-induced economic uncertainty. Utilizing Malawi as a case study, we introduce the application of Stochastic Dominance (SD) analysis, a tool from decision analysis theory, and compare the two strategies in the context of weather/climate-associated economic uncertainty. Our findings suggest that an agriculture-led development strategy consistently surpasses its non-agriculture-led antagonist in poverty and undernourishment outcomes across almost all possible weather/climate scenarios. This underscores that, despite increasing exposure of the entire economy to weather/climate uncertainty, agriculture-led development remains the optimal strategy for Malawi to reduce poverty and undernourishment. The study also endorses the broader use of SD analysis in policy planning studies, promoting its potential to integrate risk and uncertainty into policymaking.

Adapting a Financial Incentives Intervention for Smoking Cessation with Alaska Native Families: Phase 1 Qualitative Research to Inform the Aniqsaaq (To Breathe) Study.

INTRODUCTION: Alaska Native and American Indian (ANAI) peoples in Alaska currently experience a disproportionate burden of morbidity and mortality from tobacco cigarette use. Financial incentives for smoking cessation are evidence-based, but a family-level incentive structure has not been evaluated. We used a community-based participatory research and qualitative approach to culturally adapt a smoking cessation intervention with ANAI families. METHODS: We conducted individual, semi-structured telephone interviews with 12 ANAI adults who smoke, 12 adult family members, and 13 Alaska Tribal Health System stakeholders statewide between November 2022-March 2023. Through content analysis, we explored intervention receptivity, incentive preferences, culturally aligned recruitment and intervention messaging, and future implementation needs. RESULTS: Participants were receptive to the intervention. Involving a family member was viewed as novel and aligned with ANAI cultural values of commitment to community and familial interdependence. Major themes included choosing a family member who is supportive and understanding, keeping materials positive and encouraging, and offering cash and non-cash incentives for family members to choose (e.g., fuel, groceries, activities). Participants indicated that messaging should emphasize family collaboration and that cessation resources and support tips should be provided. Stakeholders also reinforced that program materials should encourage the use of other existing evidence-based cessation therapies (e.g., nicotine replacement, counseling). CONCLUSIONS: Adaptations, grounded in ANAI cultural strengths were made to the intervention and recruitment materials based on participant feedback. Next steps include a beta-test for feasibility and a randomized controlled trial for efficacy. IMPLICATIONS: This is the first study to design and adapt a financial incentives intervention promoting smoking cessation among Alaska Native or American Indian (ANAI) peoples and the first to involve the family system. Feedback from this formative work was used to develop a meaningful family-level incentive structure with ANAI people who smoke and family members and ensure intervention messaging is supportive and culturally aligned. The results provide qualitative knowledge that can inform future family-based interventions with ANAI communities, including our planned randomized controlled trial of the intervention.

Developing a culturally relevant physical activity guide for Alaska Native Head Start students in rural Alaska: the Got Neqpiaq? Study.

Background: Concern was voiced by Elders, teachers, and parents that and playtime activities of the Head Start preschool programme were not aligned with the local Alaska Native culture in their communities.Methods: The Alaska Native Tribal Health Consortium partnered with 12 Head Start preschool programmes, administered by Rural Alaska Community Action Program in rural Alaska, to explore with community members Alaska Native value-based solutions to the concerns they raised. Local input was gathered via focus groups, interviews, and surveys.Results: We worked together with communities to create a physical activity guide specific to preschool-age children in the region. The guide includes activity descriptions, lesson plans, flash cards, and photos of traditional Alaska Native physical activities and games specific to the region. This manuscript details the community engagement process foundational to the physical activity guide's adoption and implementation.Conclusions: The processes by which the guide was developed were strength-based and participatory. Widespread community engagement and participation led to a guide that was readily adopted because the community had taken ownership of the content. The lessons learned have been invaluable in developing long-term community-based partnerships and in setting the precedent to further incorporate local/regional culture into rural Alaska Head Start programmes.

Alaska Native Parents' Decision-Making About Food, Beverages, and Screen Time for Young Children: Formative Insights From the "Got Neqpiaq?" Project.

With rising childhood obesity rates, ensuring children adopt healthy habits early is imperative. Given the unique context for Alaska Native families living in rural remote communities, who are concurrently experiencing changes in traditional practices, we investigated what impacts parents' decisions as they relate to daily living before revising a preschool curriculum focused on healthy habits. The objective of this study was to explore factors influencing parents' decisions about their children's foods, beverages, and activities. In focus group discussions with AN parents of young children across 12 communities, we asked about meals, traditional foods, beverages, physical activity, and screen time. All sessions were recorded, transcribed, and analyzed using open and selective coding to allow the most important themes to emerge. As parents discussed how they make decisions, several trends emerged related to adults' and children's food and beverage preferences; the impact of adult modeling on children; and how convenience, seasonality, access, and a reluctance to engage in conflict all impact decision-making. Parents and other community members shared important perspectives on exposing children to traditional subsistence foods and activities and passing important traditional knowledge to them at an early age. These perspectives will form the basis for preschool curricula in these communities.

Neighborhood gentrification, displacement, and severe maternal morbidity in California.

Gentrification, a racialized and profit-driven process in which historically disinvested neighborhoods experience an influx of development that contributes to the improvement of physical amenities, increasing housing costs, and the dispossession and displacement of existing communities, may influence the risk of severe maternal morbidity (SMM). Leveraging a racially diverse population-based sample of all live hospital births in California between 2006 and 2017, we examined associations between neighborhood-level gentrification and SMM. SMM was defined as having one of 21 procedures and diagnoses, as described in the SMM index developed by Centers for Disease Control and Prevention. We compared three gentrification measures to determine which operationalization best captures aspects of gentrification most salient to SMM: Freeman, Landis 3-D, and Urban Displacement Project Gentrification and Displacement Typology. Descriptive analysis assessed bivariate associations between gentrification and birthing people's characteristics. Overall and race and ethnicity-stratified mixed-effects logistic models assessed associations between gentrification and SMM, adjusting for individual sociodemographic and pregnancy factors while accounting for clustering by census tract. The study sample included 5,256,905 births, with 72,718 cases of SMM (1.4%). The percentage of individuals living in a gentrifying neighborhood ranged from 5.7% to 11.7% across exposure assessment methods. Net of individual and pregnancy-related factors, neighborhood-level gentrification, as measured by the Freeman method, was protective against SMM (OR = 0.89, 95% CI: 0.86-0.93); in comparison, gentrification, as measured by the Gentrification and Displacement Typology, was associated with greater risk of SMM (OR = 1.18, 95% CI: 1.14-1.23). These associations were significant among non-Hispanic White, non-Hispanic Black, and Hispanic individuals. Findings demonstrate that gentrification plays a role in shaping the risk of SMM among birthing people in California. Differences in how gentrification is conceptualized and measured, such as an emphasis on housing affordability compared to a broader characterization of gentrification's multiple aspects, may explain the heterogeneity in the directions of observed associations.

Aniqsaaq (To Breathe): Study protocol to develop and evaluate an Alaska Native family-based financial incentive intervention for smoking cessation.

Background: Alaska Native and American Indian (ANAI) communities in Alaska are disproportionately affected by commercial tobacco use. Financial incentive interventions promote cigarette smoking cessation, but family-level incentives have not been evaluated. We describe the study protocol to adapt and evaluate the effectiveness and implementation of a remotely delivered, family-based financial incentive intervention for cigarette smoking among Alaskan ANAI people. Methods: The study has 3 phases: 1) qualitative interviews with ANAI adults who smoke, family members, and stakeholders to inform the intervention, 2) beta-test of the intervention, and 3) randomized controlled trial (RCT) evaluating intervention reach and effectiveness on verified, prolonged smoking abstinence at 6- and 12-months post-treatment. In the RCT, adult dyads (ANAI person who smokes [index participant] and family member) recruited throughout Alaska will be randomized to a no-incentives control condition (n = 328 dyads) or a 6-month incentive intervention (n = 328 dyads). All dyads will receive cessation support and family wellness materials. Smoking status will be assessed weekly for four weeks and at three and six months. Intervention index participants will receive escalating incentives for verified smoking abstinence at each time point (maximum $750 total); the family member will receive rewards of equal value. Results: A community advisory committee contributed input on the study design and methods for relevance to ANAI people, particularly emphasizing the involvement of families. Conclusion: Our study aligns with the strength and value AIAN people place on family. Findings, processes, and resources will inform how Indigenous family members can support smoking cessation within incentive interventions. Clinical Trials Registry: NCT05209451.

Use of a National Clinical Skills Assessment Program Improves the Clinical Competency for Correctional Nurses and Advanced Practice Providers.

The Federal Bureau of Prisons clinical skills training development (CSTD) team accomplished the planning, creation, and execution of a first-ever national clinical skills assessment program (CSAP) for nurses and advanced practice providers (APPs). Clinical skills assessment is a part of nurse and APP credentialing and privileging and must be completed for new hires along with continued biennial recredentialing accreditation standards. A training resource manual, discipline-specific skills checklist, pre-/postprogram written examination, and standard operating procedures were created. The CSTD team used commercially available manikins, food items, and easily obtainable office supplies for simulated experiential skills assessments. The CSAP provided a consistent, reproducible, and scalable approach for the orientation, assessment, and, if indicated, remediation for correctional nurses and APPs.

Elevated colorectal cancer incidence among American Indian/Alaska Native persons in Alaska compared to other populations worldwide.

Colorectal cancer (CRC) is a leading cancer worldwide; incidence varies greatly by country and racial group. We compared 2018 American Indian/Alaska Native (AI/AN) CRC incidence rates in Alaska to other Tribal, racial, and international population rates. AI/AN persons in Alaska had the highest CRC incidence rate among US Tribal and racial groups (61.9/100,000 in 2018). AI/AN persons in Alaska also had higher rates than those reported for any other country in the world in 2018 except for Hungary, where males had a higher CRC incidence rate than AI/AN males in Alaska (70.6/100,000 and 63.6/100,000 respectively). This review of CRC incidence rates from populations in the United States and worldwide showed that AI/AN persons in Alaska had the highest documented incidence rate of CRC in the world in 2018. It is important to inform health systems serving AI/AN persons in Alaska about policies and interventions that can support CRC screening to reduce the burden of this disease.

Obesity Prevalence and Dietary Factors Among Preschool-Aged Head Start Children in Remote Alaska Native Communities: Baseline Data from the "Got Neqpiaq?" Study.

Background: American Indian and Alaska Native preschool-aged children experience a high prevalence of obesity, yet are under-represented in obesity prevention research. This study examined obesity prevalence and dietary risk factors among Alaska Native preschool-aged children in southwest Alaska. Methods: The study used baseline data from "Got Neqpiaq?" a culturally centered multilevel intervention focused on Yup'ik Alaska Native children, aged 3-5 years, enrolled in Head Start in 12 communities in southwest Alaska (n = 155). The primary outcomes were BMI percentile, overweight, and obesity. Dietary factors of interest were measured using biomarkers: traditional food intake (nitrogen stable isotope ratio biomarker), ultraprocessed food intake (carbon stable isotope ratio biomarker), and vegetable and fruit intake (skin carotenoid status biomarker measured by the Veggie Meter). Cardiometabolic markers (glycated hemoglobin [HbA1c] and blood cholesterol) were also measured. Results: Among the Yup'ik preschool-aged children in the study, the median BMI percentile was 91, and the prevalence of overweight or obesity was 70%. The traditional food intake biomarker was negatively associated with BMI, whereas the ultraprocessed foods and vegetable and fruit biomarkers were not associated with BMI. HbA1c and blood cholesterol were within healthy levels. Conclusions: The burden of overweight and obesity is high among Yup'ik preschool-aged children. Traditional food intake is inversely associated with BMI, which underscores the need for culturally grounded interventions that emphasize traditional values and knowledge to support the traditional food systems in Alaska Native communities in southwest Alaska. Registered with ClinicalTrials.gov #NCT03601299.

The Effect of Tobacco Use on the Expression of Placental Transporters in Alaska Native Women.

Prenatal tobacco use among Alaska Native (AN) women has decreased substantially over the past two decades. Previous research suggests that providing AN women with feedback regarding fetal exposure to tobacco may further promote cessation. Transporters in the placenta regulate fetal exposure to nutrients and xenobiotics, including compounds associated with tobacco use. We examined whether prenatal tobacco use impacts transporter expression in the placenta, and whether this is influenced by fetal sex, degree of tobacco exposure, or transporter genotype. At delivery, we obtained placental samples from AN research participants who smoked cigarettes, used commercial chew or iqmik (oral tobacco), or did not use tobacco during pregnancy. Transporter expression was evaluated using qRT-PCR and Western blotting and tested for correlations between transcript levels and urinary biomarkers of tobacco use. The impact of BCRP/ABCG2 and OATP2B1/SLCO2B1 genotypes on protein expression was also examined. Oral tobacco use was associated with decreased P-gp and increased MRP1, MRP3, LAT1, and PMAT mRNA expression. Transcript levels of multiple transporters significantly correlated with tobacco biomarkers in maternal and fetal urine. In women carrying male fetuses, both smoking and oral tobacco were associated with decreased P-gp. Oral tobacco was also associated with decreased LAT1 in women carrying female fetuses. BCRP and OATP2B1 genotypes did not appear to impact protein expression. In conclusion, prenatal tobacco use is associated with altered expression of multiple placental transporters which differs by fetal sex. As transcript levels of multiple transporters were significantly correlated with tobacco use biomarkers, eliminating prenatal tobacco use should alleviate these changes.

Facebook Intervention to Connect Alaska Native People With Resources and Support to Quit Smoking: CAN Quit Pilot Randomized Controlled Trial.

INTRODUCTION: There is some evidence that social media interventions can promote smoking cessation. This randomized controlled pilot study is the first to evaluate the feasibility and potential efficacy of a Facebook smoking cessation intervention among Alaska Native (AN) adults. AIMS AND METHODS: Recruitment and data collection occurred from December 2019 to March 2021. Participants were recruited statewide in Alaska using Facebook advertisements with a targeted sample of 60 enrolled. Participants were stratified by gender, age, and rural or urban residence and randomly assigned to receive referral resources on evidence-based cessation treatments (EBCTs) (control, n = 30) or these resources plus a 3-month, closed (private), culturally tailored, Facebook group (intervention, n = 31) that connected participants to EBCT resources and was moderated by two Alaska Native Trained Tobacco Specialists. Assessments were conducted online post-randomization at 1, 3, and 6 months. Outcomes were feasibility (recruitment, retention, and intervention engagement), self-reported use of EBCTs, and biochemically confirmed seven-day point-prevalence smoking abstinence. RESULTS: Of intervention participants, 90% engaged (eg posted, commented) more than once. Study retention was 57% at 6 months (no group differences). The proportion utilizing EBCTs was about double for intervention compared with the control group participants at 3 and 6 months. Smoking abstinence was higher for intervention than control participants at 3 months (6.5% vs. 0%, p = .16) but comparable at 6 months (6.4% vs. 6.7%, p = .97). CONCLUSIONS: While additional research is needed to promote long-term cessation, this pilot trial supports recruitment feasibility during the Coronavirus Disease 2019 (COVID-19) pandemic, consumer uptake, and a signal for intervention efficacy on the uptake of cessation treatment and short-term smoking abstinence. IMPLICATIONS: This study is the first evaluation of a social media intervention for smoking cessation among Indigenous people. We learned that statewide Facebook recruitment of AN adults who smoke was feasible and there was a signal for the efficacy of a Facebook intervention on the uptake of EBCT and short-term (3 months) biochemically verified smoking abstinence. Clinically, social media platforms may complement current care models by connecting AN individuals and others living in hard-to-reach communities to cessation treatment resources.

Exploring the perceived effectiveness and cultural acceptability of COVID-19 relevant social media intervention content among Alaska Native people who Smoke: The CAN Quit study.

Social media platforms have potential for reach and effectiveness to motivate smoking cessation and use of evidence-based cessation treatment, even during the worldwide COVID-19 pandemic. This study builds on our prior community participatory approach to developing content postings for the CAN Quit Facebook intervention among Alaska Native (AN) people who smoke. With input from a community advisory committee, we selected new content on COVID-19 preventive practices (e.g., masking) and evaluated them using a validated, six-item perceived effectiveness scale and a single item assessing cultural relevance. We obtained feedback on six content postings (two videos and four text/pictures) from an online survey administered to 41 AN people (14 men, 27 women; age range 22-61 years) who smoke in Alaska statewide with 49 % residing in rural Alaska. Perceived effectiveness scale scores were high across postings, ranging from 3.9 to 4.4 out of a maximum score of 5.0. Cultural relevance item scores ranged from 3.9 to 4.3. We found no appreciable differences by sex, age, or rural/urban location for either score. This study adds new information on the adaptation, acceptability, and perceived effectiveness of content on COVID-19 preventive practices for future inclusion in a social media-based intervention for smoking cessation specifically tailored for AN people.

Impact of a Prenatal Vitamin D Supplementation Program on Vitamin D Deficiency, Rickets and Early Childhood Caries in an Alaska Native Population.

Background: Early childhood rickets increased in Alaska Native children after decreases in vitamin D-rich subsistence diet in childbearing-aged women. We evaluated the impact of routine prenatal vitamin D supplementation initiated in Alaska's Yukon Kuskokwim Delta in Fall 2016. Methods: We queried electronic health records of prenatal women with 25(OH) vitamin D testing during the period 2015−2019. We evaluated 25(OH)D concentrations, vitamin D3 supplement refills, and decayed, missing, and filled teeth (dmft) scores and rickets in offspring. Results: Mean 25(OH)D concentrations increased 36.5% from pre- to post-supplementation; the percentage with deficient 25(OH)D decreased by 66.4%. Women with ≥ 60 vitamin D3 refill days had higher late pregnancy 25(OH)D concentrations than those with no refill days (p < 0.0001). Women with late pregnancy insufficient 25(OH)D concentrations had offspring with higher dmft scores than those with sufficient 25(OH)D (RR 1.3, p < 0.0001). Three children were diagnosed with nutritional rickets during the period 2001−2021, and none after 2017. Conclusions: These findings suggest that prenatal vitamin D supplementation can improve childhood outcomes in high-risk populations with high rates of rickets.

Testing of a mobile heating facility to sanitize N-95 respirators against an enveloped respiratory virus.

In the spring of 2020, the Alaska Native Tribal Health Consortium (ANTHC) designed and built a sanitizing treatment system to address shortages of filtering facepiece respirators (FFRs). The design criteria included sanitizing large numbers of FFRs, repeatedly achieving FFR fit test requirements, and deactivating enveloped respiratory viruses, such as SARS-CoV-2. The outcome was the Mobile Sanitizing Trailer (MST), a 20 by 8-foot modified trailer designed to process up to 1,000 FFRs during a standard heat cycle. This paper reports on the MST's ability to: (1) sustain a target temperature, (2) produce tolerable conditions for FFRs as measured by fit factor and (3) successfully deactivate an infectious model virus. We found that the MST reliably and uniformly produced 75 degrees Celsius in the treatment chamber for the prescribed periods. Quantitative analysis showed that the FFRs achieved acceptable post-treatment fit factor even after 18, 60-minute heat cycles. Finally, the treated FFR materials had at least a log 3.0 reduction in viral RNA and no viable virus after 30, 60 or 90 minutes of heat treatment. As a sanitizing treatment during supply shortages, we found the MST a viable option for deactivation of virus and extending the usable life of FFRs.

Lessons Learned From Beta-Testing a Facebook Group Prototype to Promote Treatment Use in the "Connecting Alaska Native People to Quit Smoking" (CAN Quit) Study.

Social media provides an effective tool to reach, engage, and connect smokers in cessation efforts. Our team developed a Facebook group, CAN Quit (Connecting Alaska Native People to Quit smoking), to promote use of evidence-based smoking cessation resources for Alaska Native people living in Alaska, which are underused despite their effectiveness. Often separated by geography and climate, Alaska Native people prefer group-based approaches for tobacco cessation that support their culture and values. Such preferences make Alaska Native people candidates for social media-based interventions that promote connection. This viewpoint discusses the steps involved and lessons learned in building and beta-testing our Facebook group prototype, which will then be evaluated in a pilot randomized controlled trial. We describe the process of training moderators to facilitate group engagement and foster community, and we describe how we developed and tested our intervention prototype and Facebook group. All parts of the prototype were designed to facilitate use of evidence-based cessation treatments. We include recommendations for best practices with the hope that lessons learned from the CAN Quit prototype could provide a model for others to create similar platforms that benefit Alaska Native and American Indian people in the context of smoking cessation.

Health-related economic benefits of universal access to piped water in Arctic communities: Estimates for the Yukon-Kuskokwim Delta region of Alaska.

This paper presents estimates of the potential health-related economic benefits of providing universal access to in-home water and sanitation services to households in rural Alaska. In particular, we use data on disease incidence rates, health care costs, and local estimates of the impact of piped water on disease reduction to estimate the potential health-related economic benefits of providing universal access to piped water in the Yukon Kuskokwim (Y.K.) Delta region of Alaska. We include estimates of avoided treatment and diagnosis costs as well as private benefits associated with reduced morbidity and mortality associated with improved access to in-home piped water. To our knowledge, these are the first estimates of the economic benefits of improved access to water and sanitation in rural Alaska and the Arctic. Our analysis suggests increased access to in-home piped water in the region may yield substantial reductions in direct medical expenses incurred by public agencies and families, as well as reductions in time and travel costs associated with improved health outcomes. These benefits, along with the array of health and non-health-related benefits not included in our analysis, may provide new impetus to expanding access to high-quality water and sanitation services in the region.

Impact of Assistance Programs on Indigenous Ways of Life in 12 Rural Remote Western Alaska Native Communities: Elder Perspectives Shared in Formative Work for the "Got Neqpiaq?" Project.

For more than 50 years, government programmes in the USA have been in place to help those in need have consistent access to food and education. However, questions have surfaced regarding whether or not these support impact traditional ways, such as cultural activities, food preferences, and overall health, particularly for Indigenous populations. In this paper, we share insights voiced by Alaska Native Elders in the Yukon-Kuskokwim region of Alaska and their perceptions of regulations, assistance, and the impact government assistance programmes have had on their culture. Elders raised concerns so that those administering these programmes will consider how best to meet food security and education needs without interfering with Indigenous cultural practices and traditional lifestyle.

Alaska Native Elders' perspectives on dietary patterns in rural, remote communities.

BACKGROUND: Given the increasing rates of childhood obesity in Alaska Native children and the understanding that the most effective interventions are informed by and reflect the cultural knowledge of the community in which they are implemented, this project sought to gather the wisdom of local Yup'ik and Cup'ik Elders in the Yukon-Kuskokwim region of Alaska around how to maintain a healthy diet and active lifestyle. METHODS: Perspectives were sought through the use of semi-structured focus groups, which were completed in person in twelve communities. All conversations were recorded, translated, transcribed, and analyzed using a qualitative approach, where key themes were identified. RESULTS: Elders provided a clear and consistent recollection of what their life looked like when they were young and expressed their perspectives related to maintaining a healthy and traditional lifestyle. The key themes the Elders discussed included an emphasis on the nutritional and cultural benefits of traditional foods; concerns around changing dietary patterns such as the consumption of processed foods and sugar sweetened beverages; and concerns on the time and use of screens. Elders also expressed a desire to help younger generations learn traditional subsistence practices. CONCLUSIONS: The risk of obesity in Alaska Native children is high and intervention efforts should be grounded in local knowledge and values. The perspectives from Yup'ik and Cup'ik Elders in the Yukon-Kuskokwim Delta area of Alaska provide a better understanding on local views of how to maintain a healthy diet, physical activities, and traditional values.

Storekeeper perspectives on improving dietary intake in 12 rural remote western Alaska communities: the "Got Neqpiaq?" project.

Low intake of fruits and vegetables and high intake of sugar-sweetened beverages persists as a public health concern in rural remote Alaska Native (AN) communities. Conducting key informant interviews with 22 storekeepers in 12 communities in the Yukon-Kuskokwim region of Alaska, we explored potential factors impeding or facilitating dietary change towards healthier food choices. We selected these sites as part of a multi-level intervention aimed at introducing more traditional AN subsistence foods, increasing fruit and vegetable intake, and decreasing SSB consumption among young children enrolled in Head Start (preschool) programmes (Clinicaltrials.gov #NCT03601299). Storekeepers in these communities agreed that seasonality and flight schedules were primary factors determining commercial foods' availability. Several storekeepers noted that federal food assistance programmes that specify which food items may be purchased with funds received from the programme and community policies that set limits on less healthy items promote customer purchases of healthier products. The fact that storekeepers are comfortable enforcing government assistance programme guidelines, company policies, and tribal resolutions suggests an important role storekeepers play in improving nutritional intake in their communities.

Dietary fibre to reduce colon cancer risk in Alaska Native people: the Alaska FIRST randomised clinical trial protocol.

INTRODUCTION: Diet, shown to impact colorectal cancer (CRC) risk, is a modifiable environmental factor. Fibre foods fermented by gut microbiota produce metabolites that not only provide food for the colonic epithelium but also exert regulatory effects on colonic mucosal inflammation and proliferation. We describe methods used in a double-blinded, randomised, controlled trial with Alaska Native (AN) people to determine if dietary fibre supplementation can substantially reduce CRC risk among people with the highest reported CRC incidence worldwide. METHODS AND ANALYSES: Eligible patients undergoing routine screening colonoscopy consent to baseline assessments and specimen/data collection (blood, urine, stool, saliva, breath and colon mucosal biopsies) at the time of colonoscopy. Following an 8-week stabilisation period to re-establish normal gut microbiota post colonoscopy, study personnel randomise participants to either a high fibre supplement (resistant starch, n=30) or placebo (digestible starch, n=30) condition, repeating stool sample collection. During the 28-day supplement trial, each participant consumes their usual diet plus their supplement under direct observation. On day 29, participants undergo a flexible sigmoidoscopy to obtain mucosal biopsy samples to measure the effect of the supplement on inflammatory and proliferative biomarkers of cancer risk, with follow-up assessments and data/specimen collection similar to baseline. Secondary outcome measures include the impact of a high fibre supplement on the oral and colonic microbiome and biofluid metabolome. ETHICS AND DISSEMINATION: Approvals were obtained from the Alaska Area and University of Pittsburgh Institutional Review Boards and Alaska Native Tribal Health Consortium and Southcentral Foundation research review bodies. A data safety monitoring board, material transfer agreements and weekly study team meetings provide regular oversight throughout the study. Study findings will first be shared with AN tribal leaders, health administrators, providers and community members. Peer-reviewed journal articles and conference presentations will be forthcoming once approved by tribal review bodies. TRIAL REGISTRATION NUMBER: NCT03028831.