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

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ClinicalTrials.gov Identifier: NCT05654142
Recruitment Status : Recruiting
First Posted : December 16, 2022
Last Update Posted : May 10, 2023
Sponsor:
Collaborators:
Washington University School of Medicine
University of Pittsburgh
Information provided by (Responsible Party):
Jun Ma, University of Illinois at Chicago

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.


Condition or disease Intervention/treatment Phase
CARDIOMETABOLIC CONDITIONS Obesity Pre-diabetes Metabolic Syndrome Type2diabetes Hypertension Dyslipidemias Behavioral: Base intervention Behavioral: Augmented Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1029 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The PIVOT Trial: Project on EHR-Integrated Lifestyle Interventions for Adults Aged Fifty and Older
Actual Study Start Date : April 17, 2023
Estimated Primary Completion Date : October 31, 2026
Estimated Study Completion Date : October 31, 2026

Arm Intervention/treatment
Active Comparator: Group A: Waitlist-Base Intervention
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.
Behavioral: Base intervention
12 Group Lifestyle Balance videos and digital motivational messages

Active Comparator: Group B: Waitlist-Augmented Intervention
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.
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

Experimental: Group C: Base Intervention (Responders)
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.
Behavioral: Base intervention
12 Group Lifestyle Balance videos and digital motivational messages

Experimental: Group D: Base Intervention (Non-responders)
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.
Behavioral: Base intervention
12 Group Lifestyle Balance videos and digital motivational messages

Experimental: Group E: Augmented Intervention (Non-responders)
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.
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




Primary Outcome Measures :
  1. Assess changes in weight at baseline 0, 6, 12,24 and 52 [ Time Frame: Baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05654142


Locations
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United States, Illinois
Department of Medicine, Vitoux Program on Aging and Prevention Recruiting
Chicago, Illinois, United States, 60608
Contact: Jun Ma, MD, PhD    312-413-9830    maj2015@uic.edu   
Contact: Amruta Barve, MPH    7377810681    amruta@uic.edu   
United States, Missouri
Washington University School of Medicine in St Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Thomas Kannampallil, PhD    314-273-7801    thomas.k@wustl.edu   
United States, Pennsylvania
University of Pittsburgh School of Medicine Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Elizabeth Venditti, PhD    412-647-1027    vendittiem@upmc.edu   
Sponsors and Collaborators
University of Illinois at Chicago
Washington University School of Medicine
University of Pittsburgh
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Responsible Party: Jun Ma, MD, PhD, Principal Investigator, Beth and George Vitoux Professor of Medicine, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT05654142    
Other Study ID Numbers: 2022-1230
First Posted: December 16, 2022    Key Record Dates
Last Update Posted: May 10, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Metabolic Syndrome
Dyslipidemias
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism
Lipid Metabolism Disorders