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

Launched by UNIVERSITY OF ILLINOIS AT CHICAGO · Dec 8, 2022

Keywords

ClinConnect Summary

The PIVOT Trial is a research study focused on helping adults aged 50 to 74 improve their health through better eating and exercise habits. The trial will explore whether using a video-based lifestyle program, combined with coaching over the phone or video, can help participants achieve better weight loss and reduce their risk for conditions like obesity, diabetes, and high blood pressure. The goal is to see how well this program can be delivered directly to participants at home using their electronic health records, making it easier for patients to access support for healthier living.

To join the study, participants must be between 50 and 74 years old and have a body mass index (BMI) of 27 or higher, along with a diagnosis of a health condition like pre-diabetes or high blood pressure. Participants will receive tools to help track their weight and activity and will be involved in various aspects of the program. It's important to note that individuals with certain health issues or who are currently undergoing other weight loss treatments may not be eligible for this trial. Overall, this study aims to find effective ways to support healthier lifestyles in older adults, which could lead to more personalized care in the future.

Gender

ALL

Eligibility criteria

• 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 scale
• • Height documented in the EHR during at least 2 separate ambulatory care encounters within the past 2 years
• • Diagnosis of 1 or more cardiometabolic condition (prediabetes, metabolic syndrome, type 2 diabetes, hypertension, dyslipidemia) in the EHR
• • Willing and able to accept randomization, and provide written informed consent and HIPAA authorization
• • Willing 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 apps
• Exclusion Criteria:
• • Unable to speak, read, understand English sufficiently for informed consent
• • No reliable Wi-Fi Internet access at home
• • Self-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 medications
• • Screen positive for active eating disorder (bulimia nervosa or binge eating disorder) using PHQ- eating disorder module
• • Planned 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 participate
• • Presence 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 screener
• • Active 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 months
• • Participation 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 member
• • Investigator discretion for clinical safety or protocol adherence reasons