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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 belowSelect...
I am between 50 and 74 years old.
Select...
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
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 moreAwards & 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
Find a Location
Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
640 Previous Clinical Trials
1,567,769 Total Patients Enrolled
University of PittsburghOTHER
1,792 Previous Clinical Trials
16,358,957 Total Patients Enrolled
Washington University School of MedicineOTHER
2,000 Previous Clinical Trials
2,343,233 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your weight and height measurements show that you have a high body mass index (BMI).I am between 50 and 74 years old.I have not had weight loss surgery in the last 2 years.I am willing to use a study-provided scale, activity tracker, and tablet for the trial.You have a current diagnosis of bulimia nervosa or binge eating disorder based on a specific questionnaire.I have been diagnosed with a condition like prediabetes, high blood pressure, or high cholesterol.You have trouble with thinking and memory based on a specific test.You have serious physical or mental health issues, such as type 1 diabetes, recent heart attack or stroke, active cancer treatment, or end-stage organ failure.You have a problem with drinking alcohol or using drugs.I am currently on a weight loss program or taking prescription weight loss medication.You do not have a good Wi-Fi connection at home.
Research Study Groups:
This trial has the following groups:- Group 1: Group E: Augmented Intervention (Non-responders)
- Group 2: Group A: Waitlist-Base Intervention
- Group 3: Group C: Base Intervention (Responders)
- Group 4: Group B: Waitlist-Augmented Intervention
- Group 5: Group D: Base Intervention (Non-responders)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Cardiometabolic Conditions Patient Testimony for trial: Trial Name: NCT05654142 — N/A