Lifestyle Interventions for Obesity

(PIVOT Trial)

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Weight loss medications

Disqualifiers: Eating disorders, Bariatric surgery, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1029 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether digital lifestyle programs, with or without coaching, can help individuals aged 50–74 lose weight and reduce their risk of chronic diseases. Participants will watch video sessions on healthy eating and exercise, and some will receive personalized support from a coach via video calls or phone. The study aims to understand why some individuals achieve better results than others, enabling future programs to be more personalized. Suitable participants have a BMI of 27 or higher and a condition such as prediabetes or high blood pressure. As an unphased trial, participants contribute to developing more effective, personalized health programs.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, you cannot participate if you are currently using prescription weight loss medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the treatments in this trial focus on lifestyle changes and have undergone prior safety testing. The main treatment uses a program called Group Lifestyle Balance (GLB), which other studies have proven effective and safe. Participants in those studies reported very few negative effects.

Strong evidence also supports the enhanced treatment, which includes extra coaching and support. Problem-solving therapy (PST), part of this treatment, has been safely used in similar situations. Studies involving PST showed that participants handled it well and didn't report major issues.

While past research suggests these treatments are safe, joining a clinical trial is a personal choice. It's always advisable to consult a healthcare provider if there are any concerns or questions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores personalized lifestyle interventions for obesity, which could provide more tailored and effective weight loss solutions. Unlike standard treatments that often rely solely on diet and exercise plans, this trial incorporates digital messages and Problem-Solving Therapy (PST) delivered by trained coaches via videoconference. This approach not only provides ongoing support but also adapts based on individual responses, offering an innovative way to enhance motivation and adherence. By addressing both the physical and psychological aspects of weight loss, this trial could lead to more sustainable outcomes for individuals struggling with obesity.

What evidence suggests that this trial's lifestyle interventions could be effective for obesity?

Research has shown that the Base Intervention, which uses the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB), effectively helps people lose weight. This program has succeeded in the general population by focusing on reducing calorie and fat intake and increasing physical activity. Studies indicate that longer adherence to this program results in greater weight loss. In this trial, some participants will receive the Base Intervention.

Other participants will receive the Augmented Intervention, which adds Problem Solving Treatment (PST) with coaching through video calls or phone. This method aims to boost weight loss further by offering personalized support and strategies to overcome challenges. Early findings suggest that this enhanced approach can lead to better results than the base program alone. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willing and able to accept randomization, and provide written informed consent and HIPAA authorization

Your weight and height measurements show that you have a high body mass index (BMI).

I am between 50 and 74 years old.

Exclusion Criteria

Unable to pass the Revised Physical Activity Readiness Questionnaire (PAR-Q) or obtain physician medical clearance to participate

I have not had weight loss surgery in the last 2 years.

You have a current diagnosis of bulimia nervosa or binge eating disorder based on a specific questionnaire.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive the base intervention or are placed in a waitlist control for 12 weeks

12 weeks

Remote interactions via patient portal

Adaptive Treatment

Non-responders receive augmented intervention with PST coaching; responders continue base intervention

40 weeks

Remote coaching via videoconference or phone

Follow-up

Participants are monitored for weight change and other health metrics

52 weeks

Regular remote monitoring and self-reporting

What Are the Treatments Tested in This Trial?

Interventions

• Augmented Intervention
• Base intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: Group E: Augmented Intervention (Non-responders) Experimental Treatment 1 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 Treatment 1 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 Treatment 1 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 Intervention Active Control 1 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 Intervention Active Control 1 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.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

The adapted Group Lifestyle Balance (GLB) intervention was successfully implemented in a diabetes education program, showing feasibility and effectiveness for weight management among 111 overweight/obese adults, regardless of their diabetes status.

Participants achieved significant weight loss and increased their physical activity, with many reporting exercising at least 150 minutes per week after completing the 12-week program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting the Group Lifestyle Balance™ Program for Weight Management Within a Large Health Care System Diabetes Education Program. Greenwood, DA., Kramer, MK., Hankins, AI., et al.[2021]

A community-based modified Diabetes Prevention Program, called Group Lifestyle Balance (GLB), effectively helped individuals with metabolic syndrome lose weight, with 46.4% of participants losing at least 5% of their body weight after a 12-week intervention.

Improvements in metabolic syndrome components were observed, with 43.5% of participants showing positive changes, and many of these improvements were sustained at a 6-month follow-up, indicating the potential for long-term benefits in reducing the risk of type 2 diabetes and cardiovascular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating the Diabetes Prevention Program into an urban medically underserved community: a nonrandomized prospective intervention study. Seidel, MC., Powell, RO., Zgibor, JC., et al.[2022]

The Group Lifestyle Balance program (GLB), adapted from the Diabetes Prevention Program (DPP), was evaluated in a pilot project using a DVD format with remote support.

Results indicate that the GLB-DVD with remote support could be an effective alternative method for delivering lifestyle intervention programs, potentially improving accessibility for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel approach to diabetes prevention: evaluation of the Group Lifestyle Balance program delivered via DVD. Kramer, MK., Kriska, AM., Venditti, EM., et al.[2022]

The Group Lifestyle Balance (GLB) program, based on the Diabetes Prevention Program, effectively reduced the prevalence of prediabetes by 2.0%, obesity by 8.7%, and metabolic syndrome by 6.8% among participants who completed the 12-week intervention.

Despite a high initial attendance of 704 patients, only 52% completed the program, with significant dropouts occurring within the first four weeks, particularly among active duty military members, highlighting the need for strategies to improve retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Group Lifestyle Balance Program in a Military Setting: An Investment Worth Expanding. Wardian, JL., True, MW., Sauerwein, TJ., et al.[2019]

The enriched Group Lifestyle Balance (GLB) program, which incorporated habit formation tools, did not lead to greater long-term weight loss maintenance compared to the standard GLB, with both groups experiencing an average weight regain of 7.85 lbs after 24 months.

Despite some weight regain, participants in both groups maintained a significant portion of their weight loss, remaining 12.51 lbs (6.13%) lighter than their baseline weight at the 24-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of if-then plans on weight loss: results of the 24-month follow-up of the McGill CHIP Healthy Weight Program randomized controlled trial. Knäuper, B., Shireen, H., Carrière, K., et al.[2020]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11090521

Project Details - NIH RePORTER Aim 1 is to demonstrate intervention effects on weight loss, behavior change, and patient-reported outcomes. We hypothesize: (1) the augmented intervention will ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05654142

Study Details | NCT05654142 | The PIVOT Trial: Project on ... 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, ...

3. withpower.com withpower.com/trial/phase-hypertension-1-2023-060dd

Lifestyle Interventions for Obesity (PIVOT Trial) The Augmented Intervention treatment for obesity is unique because it combines the Group Lifestyle Balance (GLB) video program with Problem Solving Treatment ( ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05654142/the-pivot-trial-project-on-ehr-integrated-lifestyle-interventions-for-adults-aged-fifty-and-older

The PIVOT Trial: Project on EHR-Integrated Lifestyle ... This study will investigate whether a proven, self-directed video-based lifestyle program can be significantly enhanced with the assistance of a ...

5. reporter.nih.gov reporter.nih.gov/search/aqoTltIQGkaCFojzy6WakQ/project-details/11090521

Project on EHR-Integrated Lifestyle Interventions for Adults Aged ... Responders to the base intervention, defined by ≥3% weight loss at 6 weeks, will continue the base intervention; participants with <3% weight loss or missing ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8538071/

Translating evidence-based behavioral weight loss into a ... The Wellness Engagement (WE) Project sought to translate evidence-based BWL within a CBPR framework to promote change across multiple domains of influence.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0002916522005378

Problem-solving therapy–induced amygdala engagement ... Adults (n = 108) with obesity and depression were randomly assigned to usual care or an intervention that delivered problem-solving therapy (PST) for ...