Implementation science strategies promote fidelity in a cluster randomized controlled trial: The Food, Feeding, and Your Family Study

Authors: ARAGON, M - Washington State University Extension Service; AULD, GARY - Colorado State University; BAKER, SUSAN - Colorado State University; BARALE, KAREN - Washington State University Extension Service; SILVA GARCIA, KARINA - Washington State University; MICHELI, NILDA - Children'S Nutrition Research Center (CNRC); PARKER, LOUISE - Washington State University Extension Service; LANIGAN, JANE - Washington State University; POWER, THOMAS - Washington State University; HUGHES, SHERYL - Children'S Nutrition Research Center (CNRC)

Submitted to: Journal of Nutrition Education and Behavior
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 6/1/2021
Publication Date: 7/21/2021
Citation: Aragon, M.C., Auld, G., Baker, S.S., Barale, K.V., Silva Garcia, K., Micheli, N., Parker, L., Lanigan, J., Power, T.G., Hughes, S.O. 2021. Implementation science strategies promote fidelity in a cluster randomized controlled trial: The Food, Feeding, and Your Family Study. Journal of Nutrition Education and Behavior. 53(12):1028-1037. https://doi.org/10.1016/j.jneb.2021.06.001.
DOI: https://doi.org/10.1016/j.jneb.2021.06.001

Interpretive Summary: Assessment of the implementation of an intervention is necessary to accurately assess intervention outcomes. Methodological strategies used to monitor the validity of behavioral interventions include assessments of treatment integrity (whether the intervention was delivered as intended) and treatment differentiation (whether treatment conditions differed in an intended manner with no cross-contamination). Most research interventions including those that test implementation take place in relatively controlled environments. When effective research programs are transferred to the community, outcomes typically weaken. Embedding research interventions into established community programs may promote better community outcomes. Food, Feeding and Your Family (FFYF) is a program that encourages child eating self-regulation. The FFYF program was delivered in the states of Colorado and Washington via the federally funded Expanded Food and Nutrition Education Program (EFNEP). The current study describes the design steps implemented to promote program and curriculum fidelity. As part of testing the efficacy of FFYF, a cluster randomized controlled trial with three conditions (control with Eating Smart Being Active only, FFYF in-class, or FFYF online) was conducted. Participants in all conditions completed a series of lessons and participated in assessments at pre-intervention, post-intervention, 6 months after intervention, and 12 months after intervention. implementation strategies included extensive educator training, the use of scripted curriculum, and frequent feedback. Additionally, observations of 20% of the lessons were performed. Fidelity compliance was assessed, and a qualitative analysis of verbatim educator interviews and classroom observer comments was conducted. Results of the FFYF implementation assessments showed that peer educators followed the scripted lesson plan 78-89% of the time; no evidence of cross-contamination of the content was seen and only minor sharing in the online condition; and that variations in fidelity were primarily tied to the EFNEP curriculum. The retention rate for this trial was 74% at 12 months after the intervention ended. Strategies that contributed to the 74% retention included using bilingual staff and peer educators, who built rapport with participants, cash incentives for completing FFYF data collections, and phone calls or texts to maintain contact. In addition, recruiting through agencies, particularly elementary schools and early learning centers, for which EFNEP had established relations, facilitated continued contacts with participants. Overall, these results indicate that the careful consideration and application of critical Implementation Science factors contributed to the successful delivery of a complex community nutrition education intervention with high program and curriculum fidelity. Programs that value fidelity and have the infrastructure and organization culture to support research protocols may promote more successful programmatic implementation of research-tested approaches.

Technical Abstract: The objective of our study was the use of implementation science strategies to promote fidelity in the Food, Feeding, and Your Family Study (FFYF). Cluster randomized controlled trial with 3 conditions: control, in-class, or online, delivered in English or Spanish. Observations of 20% of classes. The setting for this was Expanded Food and Nutrition Education Program (EFNEP) in 2 states. EFNEP peer educators (n=11). Parental feeding content incorporated into EFNEP lessons (in-class) or through text with links to videos/activities (online). Extensive educator training, scripted curriculum, frequent feedback. Assessment of fidelity compliance. Qualitative analysis of verbatim educator interviews and classroom observer comments. During 128 class observations (40-45 per condition), peer educators followed scripted lesson plan 78-89 percent of the time. No evidence of cross-contamination of parental feeding content in control and only minor sharing in online conditions. Variations in fidelity were primarily tied to the EFNEP curriculum not the parent feeding content. Educators (n=7) expressed favorable opinions about FFYF, thought it provided valuable information, and appreciated support from EFNEP leadership. Incorporating implementation science strategies can help to ensure successful adherence to research protocols. With proper training and support, EFNEP peer educators can deliver an evidence-based curriculum as part of a complex research study.