← Back to Search

Lifestyle Interventions for Obesity (PIVOT Trial)

N/A
Recruiting
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Age 50 - 74 years (inclusive)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks
Awards & highlights

PIVOT Trial Summary

This trial will investigate how a lifestyle program and coaching can help middle-aged adults reduce their risk for chronic disease by improving their weight. Results may help to tailor the program for personalized care.

Who is the study for?
Adults aged 50-74 with a BMI ≥27 and diagnosed with conditions like high blood pressure, dyslipidemia, or type 2 diabetes can join. They must be willing to use digital tools for monitoring and have Wi-Fi at home. Exclusions include active weight loss treatment, substance abuse disorders, serious health issues like recent heart attack or cancer treatment.Check my eligibility
What is being tested?
The PIVOT Trial is testing if a video-based lifestyle program improves weight and reduces chronic disease risk in older adults when enhanced by remote coaching. It explores personal success factors and integrates the program into patients' electronic health records for easy access at home.See study design
What are the potential side effects?
Since this trial involves lifestyle changes rather than medication, side effects are not typical as with drug trials. However, participants may experience discomfort adjusting to new diet or exercise routines.

PIVOT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am willing to use a study-provided scale, activity tracker, and tablet for the trial.
Select...
I am between 50 and 74 years old.
Select...
I have been diagnosed with a condition like prediabetes, high blood pressure, or high cholesterol.

PIVOT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess changes in weight at baseline 0, 6, 12,24 and 52

PIVOT Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Group E: Augmented Intervention (Non-responders)Experimental Treatment1 Intervention
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.
Group II: Group D: Base Intervention (Non-responders)Experimental Treatment1 Intervention
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.
Group III: Group C: Base Intervention (Responders)Experimental Treatment1 Intervention
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.
Group IV: Group A: Waitlist-Base InterventionActive Control1 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.
Group V: Group B: Waitlist-Augmented InterventionActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Base intervention
2019
N/A
~70

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
604 Previous Clinical Trials
1,557,566 Total Patients Enrolled
Washington University School of MedicineOTHER
1,928 Previous Clinical Trials
2,295,935 Total Patients Enrolled
University of PittsburghOTHER
1,716 Previous Clinical Trials
16,345,425 Total Patients Enrolled

Media Library

Augmented Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05654142 — N/A
Cardiometabolic Conditions Research Study Groups: Group D: Base Intervention (Non-responders), Group E: Augmented Intervention (Non-responders), Group A: Waitlist-Base Intervention, Group B: Waitlist-Augmented Intervention, Group C: Base Intervention (Responders)
Cardiometabolic Conditions Clinical Trial 2023: Augmented Intervention Highlights & Side Effects. Trial Name: NCT05654142 — N/A
Augmented Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05654142 — N/A
Cardiometabolic Conditions Patient Testimony for trial: Trial Name: NCT05654142 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I potentially qualify to partake in this exploration?

"To be eligible for this trial, individuals should have high blood pressure and must fall within the age range of 50-74. Currently, 1029 participants are being sought after for enrollment."

Answered by AI

Does this trial include geriatric individuals?

"This clinical study is looking for patient participation from those aged 50 to 74. Concomitantly, there are 438 studies currently recruiting people under 18 years old and 2231 studies that involve patients over 65."

Answered by AI

Does this clinical research have any open enrollment opportunities currently?

"As per the clinicaltrials.gov information, this particular trial is not currently recruiting patients. This research was first made available on February 1st 2023 and its last edition occurred 8th December 2022. Although no longer seeking participants for this study, 2993 other trials are presently enrolling individuals."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
Illinois
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
University of Pittsburgh School of Medicine
Washington University School of Medicine in St Louis
Department of Medicine, Vitoux Program on Aging and Prevention
How many prior treatments have patients received?
3+
0

Why did patients apply to this trial?

Need to lower blood pressure and blood sugar. The only time I can lose weight is when I'm seriously ill. I finally got.
PatientReceived no prior treatments
I don’t want to get any type of diabetes, looking for help to accomplish my goal.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Will I have to eat fish?
PatientReceived 1 prior treatment
~686 spots leftby Oct 2026