Dataset Information

Recruitment best practices of a cardiovascular risk reduction randomised control trial in rural Alaska Native communities.

ABSTRACT: Though not native to Alaska, tobacco use is common among Alaska Native people in the Norton Sound region, an area consisting of 16 communities with population size 107 to 3,695. We summarise best practices in recruiting Alaska Native adults who smoke for a randomised controlled tobacco treatment trial. Participants were Alaska Native, 19 years and older, smoking daily, with hypertension and/or high cholesterol, residing in the Norton Sound region of Alaska. Study staff travelled to the remote communities to recruit, typically staying 5 days. Screening and enrolment success was examined by day, season, and staffing level. From June 2015 - December 2018, the study team made 122 trips, screening 1089 individuals and enrolling 314 participants. In the field, days 2-3 (51%) were best for screening, while days 3-4 (53%) had the greatest enrolment. Community size correlated with enrolment (r = 0.83, p <.001). Recruitment was optimised in spring and with multiple staff in the field. Despite challenges (e.g., harsh weather, poor internet connectivity), with active outreach (e.g. tabling in busy areas, attending community events, utilising mixed media, collaborating with clinic staff), the project reached its recruitment goal. Study findings can inform community-based tobacco treatment research trials in remote areas.

Abbreviations

CVD: Cardiovascular disease; VTC: Video teleconferencing; ANMC: Alaska Native Medical Centre; HEALTHH: Healing and Empowering Alaskan Lives Towards Healthy Hearts; NSHC: Norton Sound Health Corporation; RERB: Research Ethics Review Board.

SUBMITTER: Knox M

PROVIDER: S-EPMC7480599 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Recruitment best practices of a cardiovascular risk reduction randomised control trial in rural Alaska Native communities.

Knox Mariah M Skan Jordan J Benowitz Neal L NL Schnellbaecher Matthew M Prochaska Judith J JJ

International journal of circumpolar health 20201201 1

Though not native to Alaska, tobacco use is common among Alaska Native people in the Norton Sound region, an area consisting of 16 communities with population size 107 to 3,695. We summarise best practices in recruiting Alaska Native adults who smoke for a randomised controlled tobacco treatment trial. Participants were Alaska Native, 19 years and older, smoking daily, with hypertension and/or high cholesterol, residing in the Norton Sound region of Alaska. Study staff travelled to the remote co ...[more]

PMID: 32787541

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Project description:IntroductionDiet, 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 analysesEligible 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 disseminationApprovals 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 numberNCT03028831.

Dataset Information

Recruitment best practices of a cardiovascular risk reduction randomised control trial in rural Alaska Native communities.

Abbreviations

Publications

Recruitment best practices of a cardiovascular risk reduction randomised control trial in rural Alaska Native communities.

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