Lifestyle interventions for adults aged 50 and older to improve health
The PIVOT Trial: Project on EHR-Integrated Lifestyle Interventions for Adults Aged Fifty and Older
This study tests whether a video-based lifestyle program with remote coaching can help adults aged 50 and older with heart and metabolic issues improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1029 (estimated) |
| Ages | 50 Years to 74 Years |
| Sex | All |
| Sponsor | University of Illinois at Chicago Academic / other |
| Locations | 3 sites (Chicago, Illinois and 2 other locations) |
| Trial ID | NCT05654142 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a self-directed video-based lifestyle program, enhanced with remote coaching, for middle-to-older-aged adults (50-74 years) with cardiometabolic conditions. Participants will be randomized to either the base intervention or a waitlist control, with further randomization based on their weight loss response. The program aims to be delivered through the patient portal of electronic health records, utilizing telehealth tools for accessibility. The study will also explore factors influencing individual outcomes to personalize future interventions.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 50-74 with a body mass index of 27 or higher and at least one cardiometabolic condition.
Not a fit: Patients who do not speak or understand English sufficiently or lack reliable internet access at home may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve weight management and reduce the risk of chronic diseases in older adults.
How similar studies have performed: Other studies have shown success with similar lifestyle intervention approaches, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois and 2 other locations
- Department of Medicine, Vitoux Program on Aging and Prevention — Chicago, Illinois, United States (Recruiting)
- Washington University School of Medicine in St Louis — Saint Louis, Missouri, United States (Recruiting)
- University of Pittsburgh School of Medicine — Pittsburgh, Pennsylvania, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.