The PIVOT Trial: Project on EHR-Integrated Lifestyle Interventions for Adults Aged Fifty and Older

This is a multisite clinical trial of healthy lifestyle programs for middle-to-older-aged adults (50 -74 years) to improve their weight and, therefore, reduce risk for chronic disease. This study will investigate whether a proven, self-directed video-based lifestyle program can be significantly enhanced with the assistance of a coach via videoconference or phone to help people as they adopt healthy eating and exercise behaviors. Additionally, the study will examine what factors might explain why some people achieve better outcomes than others. Understanding this can help to tailor the program to an individual for personalized care in the future.Importantly, this study aims to demonstrate how readily a digital lifestyle program, with or without remote coaching, can be seamlessly delivered to patients at home via the patient portal of their electronic health record. This practical use of existing telehealth tools could be a feasible and effective means to offer behavioral treatments during routine medical care.

Inclusion Criteria:Age 50 - 74 years (inclusive)Confirmed body mass index (BMI) ≥27.0 based on:Weight measured by participant at home using the study-provided wireless weight scaleHeight documented in the EHR during at least 2 separate ambulatory care encounters within the past 2 yearsDiagnosis of 1 or more cardiometabolic condition (prediabetes, metabolic syndrome, type 2 diabetes, hypertension, dyslipidemia) in the EHRWilling and able to accept randomization, and provide written informed consent and HIPAA authorizationWilling and able to participate in all aspects of the data collection and intervention protocols, including remote monitoring with a study-provided wireless weight scale and activity tracker and the use of a study tablet for access of MyChart, REDCap, and Fitbit appsExclusion Criteria:Unable to speak, read, understand English sufficiently for informed consentNo reliable Wi-Fi Internet access at homeSelf-report of current active weight loss treatment, including research-based commercial weight loss programs (e.g., Weight Watchers, Jenny Craig, HMR, Omada, TOPS), other weight loss or related behavioral health or wellness programs led by trained personnel (professional or lay) at the recruiting clinic or in the local community, and prescription weight loss medicationsScreen positive for active eating disorder (bulimia nervosa or binge eating disorder) using PHQ- eating disorder modulePlanned or prior bariatric surgery within the last 2 years (Note: patients who are more than 2 years post bariatric surgery can participate if otherwise eligible)Unable to pass the Revised Physical Activity Readiness Questionnaire (PAR-Q) or obtain physician medical clearance to participatePresence of any significant safety concerns or contraindications related to serious physical or mental health issues based on the EHR or self-report (e.g., type 1 diabetes or insulin dependence, myocardial infarction, stroke, cancer diagnosis (other than non-melanoma skin cancer) within the past 12 months and/or actively receiving cancer treatment, end-stage organ failure, bipolar disorder, psychosis, life expectancy <12 months)Cognitive impairment based on the Callahan 6-item screenerActive alcohol or substance use disorder (including prescription drugs) based on the CAGE Questionnaire Adapted to Include Drugs (CAGE-AID)Discontinued health care at the recruiting site, or plan to discontinue in the next 12 monthsParticipation in other behavioral, medical or surgical treatment studies by self-report that conflict with the primary weight loss outcome of this study.Family/household member of an already enrolled participant or of a study team memberInvestigator discretion for clinical safety or protocol adherence reasons