Nurse-led telephone intervention for lifestyle changes on glycaemic control in people with prediabetes: Study protocol for a randomized controlled trial.

Abstract

AIM\nTo evaluate the effectiveness of a nurse-led personalized telephone lifestyle intervention versus automated SMSs in the reduction of fasting plasma glucose in adults with prediabetes.\n\n\nDESIGN\nThe PREDIPHONE is a randomized controlled, parallel, two arms, superiority trial with 15\xa0months of follow-up. Participants will be randomized to either the intervention group (teleconsultations) or the active control group (SMSs).\n\n\nMETHODS\nA total of 428 participants will be randomized in a 1:1 ratio to one of the two arms and followed up during 9\xa0months. The teleconsultations group will receive nurse-led personalized advice, while the SMSs group will receive 4-5 brief SMSs a week. Participants in both groups will receive evidence-based recommendations for diet and physical activity (PA). Outcome measures will be collected at baseline, months 4 and 9 and at month 15, to evaluate post-intervention effects.\n\n\nDISCUSSION\nPrevention of diabetes through the implementation of lifestyle interventions remains an important priority. The current pandemic situation has magnified its urgency as it heavily affected the functionality of the healthcare system. Moreover, it created the need of remotely delivering preventative interventions. This study will provide insights on the effectiveness and feasibility of a telephone-based intervention led by nurses in the amelioration of risk factors associated with diabetes.\n\n\nIMPACT\nFindings from this study will offer health services decision-makers sound evidence regarding an alternative method to face-to-face consultations that could be practical, acceptable and inexpensive, and that concretely answers the need for easily implementable prevention strategies.\n\n\nTRIAL REGISTRATION\nNCT04735640 (ClinicalTrials.gov identifier).\n\n\nPROTOCOL VERSION\nV1.0, 18/02/2021.