Lifestyle Interventions for Obesity

(PIVOT Trial)

Recruiting at 2 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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Augmented Intervention, Group Lifestyle Balance (GLB) video program augmented with Problem Solving Treatment (PST) coaching?

Research shows that the Group Lifestyle Balance (GLB) program, which focuses on changing diet and physical activity, can help with weight loss and diabetes prevention. Although the average weight loss is modest, the program is designed to be cost-effective and accessible, making it a viable option for lifestyle changes. ^{1 2 3 4 5}

Is the Group Lifestyle Balance (GLB) program safe for humans?

The Group Lifestyle Balance (GLB) program, which is a lifestyle intervention for weight management and diabetes prevention, has been evaluated in various settings and appears to be safe for humans. No specific safety concerns have been reported in the studies reviewed. ^{1 2 3 4 5}

What makes the Augmented Intervention treatment for obesity unique?

The Augmented Intervention treatment for obesity is unique because it combines the Group Lifestyle Balance (GLB) video program with Problem Solving Treatment (PST) coaching, offering a structured approach to lifestyle changes with additional support to address personal challenges, unlike traditional programs that may not include personalized coaching. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 (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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Adapting the Group Lifestyle Balance™ Program for Weight Management Within a Large Health Care System Diabetes Education Program. [2021]

2. England 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. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Translating the Diabetes Prevention Program into an urban medically underserved community: a nonrandomized prospective intervention study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Evaluation of the Group Lifestyle Balance Program in a Military Setting: An Investment Worth Expanding. [2019]

5. Ireland pubmed.ncbi.nlm.nih.gov

A novel approach to diabetes prevention: evaluation of the Group Lifestyle Balance program delivered via DVD. [2022]