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

Primary Purpose

CARDIOMETABOLIC CONDITIONS, Obesity, Pre-diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Base intervention
Augmented Intervention
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CARDIOMETABOLIC CONDITIONS

Eligibility Criteria

50 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Medicine, Vitoux Program on Aging and PreventionRecruiting
  • Washington University School of Medicine in St LouisRecruiting
  • University of Pittsburgh School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Group A: Waitlist-Base Intervention

Group B: Waitlist-Augmented Intervention

Group C: Base Intervention (Responders)

Group D: Base Intervention (Non-responders)

Group E: Augmented Intervention (Non-responders)

Arm Description

Participants in Group A will be in the waitlist control condition initially and transition to receive the base intervention at Week 12, which includes 12 GLB video sessions from Week 13-24 and digital messages from Week 25-52.

Participants in Group B will be in the waitlist control condition initially and transition to receive the augmented intervention at Week 12, which includes 12 GLB video sessions plus one-on-one PST from Week 13-24 and digital messages plus group-based PST from Week 25-52. Trained coaches will deliver the PST via videoconference (preferred) or phone.

Participants in Group C will be the individuals initially randomized to receive the base intervention who achieve 3% weight loss or more by Week 6 after completing the first 6 GLB videos. They will continue the base intervention without re-randomization and complete the next 6 GLB videos from Week 7-12 and receive digital messages from Week 13-52.

Participants in Group D will be the individuals initially randomized to receive the base intervention who do not achieve 3% weight loss by Week 6 after completing the first 6 GLB videos, and who are re-randomized to continue the base intervention. They will complete the next 6 GLB videos from Week 7-12 and receive digital messages from Week 13-52.

Participants in Group E will be the individuals initially randomized to receive the base intervention who do not achieve 3% weight loss by Week 6 after completing the first 6 GLB videos, and who are re-randomized to receive the augmented intervention. They will complete the next 6 GLB videos from Week 7-12 and receive digital messages from Week 13-52. They will also work with a trained coach via videoconference (preferred) or phone to receive one-on-one PST from Week 7-24 and group-based PST from Week 25-52.

Outcomes

Primary Outcome Measures

Assess changes in weight at baseline 0, 6, 12,24 and 52
All participants will be provided a Fitbit Aria weight scale, a Fitbit Inspire 3 activity tracker, and a study tablet (Samsung Galaxy). At baseline (0), 6, 12, 24 and 52 weeks, a study coordinator at each site who is blinded to randomization will proactively contact participants by phone, email, and/or text to remind them to weigh themselves at the same time on at least 3 days during the week. They will be instructed to weigh themselves on their study-provided Aria scale right after waking up and emptying their bladder (and bowel, if possible). They should wear only a t-shirt and undergarments, and bare feet. We will obtain participants' self-monitored weight data using a developed program for automated daily synchronization via the Fitbit open API.

Secondary Outcome Measures

Full Information

First Posted
December 8, 2022
Last Updated
May 8, 2023
Sponsor
University of Illinois at Chicago
Collaborators
Washington University School of Medicine, University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT05654142
Brief Title
The PIVOT Trial: Project on EHR-Integrated Lifestyle Interventions for Adults Aged Fifty and Older
Acronym
PIVOT
Official Title
The PIVOT Trial: Project on EHR-Integrated Lifestyle Interventions for Adults Aged Fifty and Older
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
October 31, 2026 (Anticipated)
Study Completion Date
October 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
Washington University School of Medicine, University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
This multisite clinical trial uses a 2-stage sequential randomization design to test the adaptive and nonadaptive augmentation of a validated Group Lifestyle Balance (GLB) video program (base intervention) using problem solving treatment (PST), a proven behavior therapy. The GLB video program will be delivered via the patient portal of the electronic health record system. Trained coaches will deliver PST remotely via videoconference or phone. English-speaking adults (N=1029), 50-74 years of age with a body mass index ≥27 and ≥1 cardiometabolic conditions, will be randomized at baseline to base intervention or waitlist control. Participants initially randomized to the waitlist control will be re-randomized after a 12-week control period to receive the base (Group A) or the augmented intervention (Group B), without tailoring based on early weight loss. Among participants initially randomized to the base intervention, responders defined by ≥3% weight loss at 6 weeks will continue the base intervention (Group C); nonresponders who are participants with <3% weight loss or missing weight data by 6 weeks will be re-randomized to continue the base intervention alone (Group D) or augmented with PST coaching via videoconference (Group E). We hypothesize: (1) the augmented intervention will be more effective than the base intervention both among early nonresponders to the base intervention (adaptive) and among participants in the waitlist control condition (nonadaptive) at 52 weeks; (2) the adaptive augmented intervention will be more efficacious than the base intervention and more efficacious than the waitlist control condition at 12 weeks. Aim 2 is to identify predictors of clinically significant (5%) weight loss for individual patients, using sociodemographic, clinical and behavioral engagement characteristics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CARDIOMETABOLIC CONDITIONS, Obesity, Pre-diabetes, Metabolic Syndrome, Type2diabetes, Hypertension, Dyslipidemias

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1029 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: Waitlist-Base Intervention
Arm Type
Active Comparator
Arm Description
Participants in Group A will be in the waitlist control condition initially and transition to receive the base intervention at Week 12, which includes 12 GLB video sessions from Week 13-24 and digital messages from Week 25-52.
Arm Title
Group B: Waitlist-Augmented Intervention
Arm Type
Active Comparator
Arm Description
Participants in Group B will be in the waitlist control condition initially and transition to receive the augmented intervention at Week 12, which includes 12 GLB video sessions plus one-on-one PST from Week 13-24 and digital messages plus group-based PST from Week 25-52. Trained coaches will deliver the PST via videoconference (preferred) or phone.
Arm Title
Group C: Base Intervention (Responders)
Arm Type
Experimental
Arm Description
Participants in Group C will be the individuals initially randomized to receive the base intervention who achieve 3% weight loss or more by Week 6 after completing the first 6 GLB videos. They will continue the base intervention without re-randomization and complete the next 6 GLB videos from Week 7-12 and receive digital messages from Week 13-52.
Arm Title
Group D: Base Intervention (Non-responders)
Arm Type
Experimental
Arm Description
Participants in Group D will be the individuals initially randomized to receive the base intervention who do not achieve 3% weight loss by Week 6 after completing the first 6 GLB videos, and who are re-randomized to continue the base intervention. They will complete the next 6 GLB videos from Week 7-12 and receive digital messages from Week 13-52.
Arm Title
Group E: Augmented Intervention (Non-responders)
Arm Type
Experimental
Arm Description
Participants in Group E will be the individuals initially randomized to receive the base intervention who do not achieve 3% weight loss by Week 6 after completing the first 6 GLB videos, and who are re-randomized to receive the augmented intervention. They will complete the next 6 GLB videos from Week 7-12 and receive digital messages from Week 13-52. They will also work with a trained coach via videoconference (preferred) or phone to receive one-on-one PST from Week 7-24 and group-based PST from Week 25-52.
Intervention Type
Behavioral
Intervention Name(s)
Base intervention
Intervention Description
12 Group Lifestyle Balance videos and digital motivational messages
Intervention Type
Behavioral
Intervention Name(s)
Augmented Intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Assess changes in weight at baseline 0, 6, 12,24 and 52
Description
All participants will be provided a Fitbit Aria weight scale, a Fitbit Inspire 3 activity tracker, and a study tablet (Samsung Galaxy). At baseline (0), 6, 12, 24 and 52 weeks, a study coordinator at each site who is blinded to randomization will proactively contact participants by phone, email, and/or text to remind them to weigh themselves at the same time on at least 3 days during the week. They will be instructed to weigh themselves on their study-provided Aria scale right after waking up and emptying their bladder (and bowel, if possible). They should wear only a t-shirt and undergarments, and bare feet. We will obtain participants' self-monitored weight data using a developed program for automated daily synchronization via the Fitbit open API.
Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Medicine, Vitoux Program on Aging and Prevention
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Ma, MD, PhD
Phone
312-413-9830
Email
maj2015@uic.edu
First Name & Middle Initial & Last Name & Degree
Amruta Barve, MPH
Phone
7377810681
Email
amruta@uic.edu
Facility Name
Washington University School of Medicine in St Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Kannampallil, PhD
Phone
314-273-7801
Email
thomas.k@wustl.edu
Facility Name
University of Pittsburgh School of Medicine
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Venditti, PhD
Phone
412-647-1027
Email
vendittiem@upmc.edu

12. IPD Sharing Statement

Learn more about this trial

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

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