Recruitment strategies for a randomized controlled trial in a rural American Indian community: the Cooking for Health Study

BACKGROUND: Conducting diet-focused interventions in rural, American Indian (AI), and/or under-resourced communities is critical to improve health. However, interventions that may work in urban or suburban settings may not work in rural or under-resourced communities due to differences in types of locally available food, food preferences, food insecurity, and/or limited access to grocery stores or supermarkets. This paper describes the acceptability of recruitment strategies used in the Cooking for Health (CFH) study, a culturally targeted healthy food budgeting, purchasing, and cooking skills intervention for AIs with type 2 diabetes who live on or around a large reservation in the North-Central United States. METHODS: CFH was a two-armed parallel group randomized controlled trial (RCT) designed to evaluate the effectiveness of a 12-month intervention on diet, healthy food self-efficacy, food budgeting and cooking skills, and healthy food purchases. The intervention consisted of monthly lessons and videos related to cooking healthy foods, food budgeting skills, and optimal nutrition for diabetes management. AI men and women 18 + years old with diagnosed type 2 diabetes were eligible to participate. Recruitment strategies included passive, active, and word-of-mouth (refer-a-friend) methodologies. Additionally, research staff worked closely with a community partner, the Tribal Diabetes Program, to facilitate enrollment. RESULTS: Of the 276 individuals screened for eligibility for the study, 226 individuals were deemed eligible to participate. Of these, 176 enrolled, 25 individuals scheduled a baseline study visit but did not show up, and 25 individuals declined participation. Reasons for declining participation included: no longer interested; too busy/employed full-time; already managing diabetes with own healthcare provider; or moved out of the area. CONCLUSIONS: These results support a multi-strategic recruitment approach of passive, active and word-of-mouth strategies for successful recruitment and enrollment of AIs in diet-focused RCTs. It is likely that the recruitment successes were largely due to community involvement and ownership in the study. The importance of trusting mutually beneficial and shared decision-making is also critical to project success. TRIAL REGISTRATION: ClinicalTrials.gov, TRN: NCT03699709. Registered on 5 October 2018, https://clinicaltrials.gov/study/NCT03699709.