ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-04-17
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05654142

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 74 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 50 - 74 years (inclusive)
  2. * Confirmed body mass index (BMI) ≥27.0 based on:
  3. * Weight measured by participant at home using the study-provided wireless weight scale
  4. * Height documented in the EHR during at least 2 separate ambulatory care encounters within the past 2 years
  5. * Diagnosis of 1 or more cardiometabolic condition (prediabetes, metabolic syndrome, type 2 diabetes, hypertension, dyslipidemia) in the EHR
  6. * Willing and able to accept randomization, and provide written informed consent and HIPAA authorization
  7. * 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
  1. * Unable to speak, read, understand English sufficiently for informed consent
  2. * No reliable Wi-Fi Internet access at home
  3. * 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
  4. * Screen positive for active eating disorder (bulimia nervosa or binge eating disorder) using PHQ- eating disorder module
  5. * 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)
  6. * Unable to pass the Revised Physical Activity Readiness Questionnaire (PAR-Q) or obtain physician medical clearance to participate
  7. * 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)
  8. * Cognitive impairment based on the Callahan 6-item screener
  9. * Active alcohol or substance use disorder (including prescription drugs) based on the CAGE Questionnaire Adapted to Include Drugs (CAGE-AID)
  10. * Discontinued health care at the recruiting site, or plan to discontinue in the next 12 months
  11. * Participation in other behavioral, medical or surgical treatment studies by self-report that conflict with the primary weight loss outcome of this study.
  12. * Family/household member of an already enrolled participant or of a study team member
  13. * Investigator discretion for clinical safety or protocol adherence reasons

Contacts and Locations

Study Locations (Sites)

Department of Medicine, Vitoux Program on Aging and Prevention
Chicago, Illinois, 60608
United States
Washington University School of Medicine in St Louis
St Louis, Missouri, 63110
United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: University of Illinois at Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-17
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2023-04-17
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • CARDIOMETABOLIC CONDITIONS
  • Obesity
  • Pre-diabetes
  • Metabolic Syndrome
  • Type2diabetes
  • Hypertension
  • Dyslipidemias