NCT05654142Active, not recruiting
The PIVOT Trial: Project on EHR-Integrated Lifestyle Interventions for Adults Aged Fifty and Older
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 1029 (actual)
- First submitted
- 8 Dec 2022
- Start date
- Apr 2023
- Primary completion date
- Dec 2026
- Lead sponsor
- University of Illinois Chicago
- Diseases
- Obesity, High blood pressure
- NCT number
- NCT05654142
What you commit to
- Study type: Interventional
- Participants enrolled: 1029
- From Apr 2023 to the primary completion date, Dec 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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)
- 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)
- Participation in other behavioral, medical or surgical treatment studies by self-report that conflict with the primary weight loss outcome of this study.
Other illness
- Screen positive for active eating disorder (bulimia nervosa or binge eating disorder) using PHQ- eating disorder module
- 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)
Lab values
- Unable to pass the Revised Physical Activity Readiness Questionnaire (PAR-Q) or obtain physician medical clearance to participate
Other
- Unable to speak, read, understand English sufficiently for informed consent
- No reliable Wi-Fi Internet access at home
- Discontinued health care at the recruiting site, or plan to discontinue in the next 12 months
- Family/household member of an already enrolled participant or of a study team member
- Investigator discretion for clinical safety or protocol adherence reasons
Who the study is looking for
- 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
Age in the registry: 50 years to 74 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Medicine, Vitoux Program on Aging and Prevention Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Pittsburgh School of Medicine Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Washington University School of Medicine in St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.