Active — Not RecruitingNot Applicable

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

United States1,029 participantsStarted 2023-04-17

Plain-language summary

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.

Who can participate

Age range

50 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assess change in weight from baseline to 52 weeks

Timeframe: Baseline, 52 weeks

Trial details

NCT IDNCT05654142

SponsorUniversity of Illinois at Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More CARDIOMETABOLIC CONDITIONS trials