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

NCT05654142 | Active Not Recruiting DMC

• 1 other identifier: 2022-1230
• Study Type: interventional
• Target: 1,029
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Assess change in weight from baseline to 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) 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. Participants 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.

  Baseline, 52 weeks

Secondary Outcomes (18)

• Assess change in weight from baseline to 12 weeks

  Baseline, 12 weeks,

• Assess trajectories of weight change from baseline to 6, 12, 24, and 52 weeks

  Baseline, 6 weeks, 12 weeks, 24 weeks

• Assess changes in number of steps using Fitbit activity tracker at 6, 12, 24 and 52 weeks

  Baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks

• Assess changes in physical activity using the International Physical Activity Questionnaire at 6, 12, 24 and 52 weeks

  Baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks

• Assess changes in fruit/veggie/fat/fiber intake at 6, 12, 24 and 52 weeks

  Baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks

Study Arms (5)

Group A: Waitlist-Base Intervention

ACTIVE COMPARATOR

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

Group B: Waitlist-Augmented Intervention

ACTIVE COMPARATOR

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

Group C: Base Intervention (Responders)

EXPERIMENTAL

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

Group D: Base Intervention (Non-responders)

EXPERIMENTAL

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

Group E: Augmented Intervention (Non-responders)

EXPERIMENTAL

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

Interventions

Base intervention BEHAVIORAL

12 Group Lifestyle Balance videos and digital motivational messages

Group A: Waitlist-Base Intervention; Group C: Base Intervention (Responders); Group D: Base Intervention (Non-responders)

Augmented Intervention BEHAVIORAL

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

Group B: Waitlist-Augmented Intervention; Group E: Augmented Intervention (Non-responders)

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: collaborator
• University of Pittsburgh: collaborator
• University of Illinois at Chicago: lead

Study Sites (3)

Department of Medicine, Vitoux Program on Aging and Prevention

Chicago, Illinois, 60608, United States

Location

Washington University School of Medicine in St Louis

St Louis, Missouri, 63110, United States

Location

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Obesity; Glucose Intolerance; Metabolic Syndrome; Hypertension; Dyslipidemias

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Principal Investigator, Beth and George Vitoux Professor of Medicine

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 16, 2022
• Study Start: April 17, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

US (3)