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

NCT05654142 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1029

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

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

Interventions

BEHAVIORAL

Base intervention

12 Group Lifestyle Balance videos and digital motivational messages

BEHAVIORAL

Augmented Intervention

12 Group Lifestyle Balance videos and digital motivational messages plus remote coaching for one-on-one and group-based problem-solving treatment via videoconference (preferred) or phone

Sponsors & Collaborators

  • Washington University School of Medicine

    collaborator OTHER

  • University of Pittsburgh

    collaborator OTHER

  • University of Illinois at Chicago

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
50 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-17
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05654142 on ClinicalTrials.gov