The PIVOT Trial: Project on EHR-Integrated Lifestyle Interventions for Adults Aged Fifty and Older (PIVOT)
CARDIOMETABOLIC CONDITIONS, Obesity, Pre-diabetes
About this trial
This is an interventional treatment trial for CARDIOMETABOLIC CONDITIONS
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
Sites / Locations
- Department of Medicine, Vitoux Program on Aging and PreventionRecruiting
- Washington University School of Medicine in St LouisRecruiting
- University of Pittsburgh School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Active Comparator
Active Comparator
Experimental
Experimental
Experimental
Group A: Waitlist-Base Intervention
Group B: Waitlist-Augmented Intervention
Group C: Base Intervention (Responders)
Group D: Base Intervention (Non-responders)
Group E: Augmented Intervention (Non-responders)
Participants in Group A will be in the waitlist control condition initially and transition to receive the base intervention at Week 12, which includes 12 GLB video sessions from Week 13-24 and digital messages from Week 25-52.
Participants in Group B will be in the waitlist control condition initially and transition to receive the augmented intervention at Week 12, which includes 12 GLB video sessions plus one-on-one PST from Week 13-24 and digital messages plus group-based PST from Week 25-52. Trained coaches will deliver the PST via videoconference (preferred) or phone.
Participants in Group C will be the individuals initially randomized to receive the base intervention who achieve 3% weight loss or more by Week 6 after completing the first 6 GLB videos. They will continue the base intervention without re-randomization and complete the next 6 GLB videos from Week 7-12 and receive digital messages from Week 13-52.
Participants in Group D will be the individuals initially randomized to receive the base intervention who do not achieve 3% weight loss by Week 6 after completing the first 6 GLB videos, and who are re-randomized to continue the base intervention. They will complete the next 6 GLB videos from Week 7-12 and receive digital messages from Week 13-52.
Participants in Group E will be the individuals initially randomized to receive the base intervention who do not achieve 3% weight loss by Week 6 after completing the first 6 GLB videos, and who are re-randomized to receive the augmented intervention. They will complete the next 6 GLB videos from Week 7-12 and receive digital messages from Week 13-52. They will also work with a trained coach via videoconference (preferred) or phone to receive one-on-one PST from Week 7-24 and group-based PST from Week 25-52.