ABSTRACT: BACKGROUND:Low-income older adults experience disparities in oral health problems, including caries and periodontal disease, that can exacerbate already high levels of chronic and acute health problems. Behavioral interventions have been shown to improve oral health status but are typically administered in institutional rather than community settings. Furthermore, multiple simultaneous interventions at different levels in the locations where people live and work are likely to have more impact and sustainability than single interventions in clinical settings. OBJECTIVE:This paper outlines a protocol for conducting a bilingual 5-year community-based trial of a bilevel intervention that addresses community norms, beliefs, intentions, and practices to improve oral health hygiene of vulnerable older adults living in publicly subsidized housing. The intervention utilizes (1) a face-to-face counseling approach (adapted motivational interviewing [AMI]) and (2) resident-run oral health campaigns in study buildings. METHODS:The study's modified fractional factorial crossover design randomizes 6 matched buildings into 2 conditions: AMI followed by campaign (AB) and campaign followed by AMI (BA). The total intervention cycle is approximately 18 months in duration. The design compares the 2 interventions alone (T0-T1), and in different sequences (T1-T2), using a self-reported survey and clinical assessment to measure Plaque Score (PS) and Gingival Index (GI) as outcomes. A final timepoint (T3), 6 months post T2, assesses sustainability of each sequence. The intervention is based on the Fishbein integrated model that includes both individual and contextual modifiers, norms and social influence, beliefs, attitudes, efficacy, and intention as predictors of improvements in PS, GI, and oral health quality of life. The cognitive and behavioral domains in the intervention constitute the mechanisms through which the intervention should have a positive effect. They are tailored through the AMI and targeted to building populations through the peer-facilitated oral health campaigns. The sample size is 360, 180 in each condition, with an attrition rate of 25%. The study is funded by National Institute of Dental and Craniofacial Research (NIDCR) and has been reviewed by University of Connecticut and NIDCR institutional review boards and NIDCR's clinical trials review procedures. RESULTS:When compared against each other, the face-to-face intervention is expected to have greater positive effects on clinical outcomes and oral health quality of life through the mediators. When sequences are compared, the results may be similar but affected by different mediators. The arm consisting of the BA is expected to have better sustainability. The protocol's unique features include the comparative effectiveness crossover design; the introduction of new emotion-based mediators; the balancing of fidelity, tailoring, and targeting; and resident engagement in the intervention. CONCLUSIONS:If successful, the evaluated interventions can be scaled up for implementation in other low-income congregate living and recreational settings with older adult collectives. TRIAL REGISTRATION:ClinicalTrials.gov NCT02419144; https://clinicaltrials.gov/ct2/show/NCT02419144. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/14555.
