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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

Age 50 - 74 years (inclusive)

Diagnosis of 1 or more cardiometabolic condition (prediabetes, metabolic syndrome, type 2 diabetes, hypertension, dyslipidemia) in the EHR

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 50 and 74 years old.

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I have been diagnosed with a condition like prediabetes, high blood pressure, or high cholesterol.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess change in weight from baseline to 52 weeks post randomization

Secondary study objectives

Assess changes in cardiovascular risk at 52 weeks

Assess changes in cognitive functioning at 6, 12, 24 and 52 weeks

Assess changes in efficacy in diet change at 6, 12, 24 and 52 weeks

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 2Eligibility criteria met