Intensive Lifestyle Intervention for Weight Loss

(PROPEL-IT Trial)

Overseen By Peter T Katzmarzyk, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pennington Biomedical Research Center

Must not be taking: Weight loss medications

Disqualifiers: Recent weight loss, Pregnancy, Bariatric surgery, Life-threatening disease, others

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

Compensation: Varies

Number of Visits: 6

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an innovative weight-loss program called Intensive Lifestyle Intervention, which uses a health coach to guide participants remotely through their electronic medical records. The goal is to determine if this method can effectively help people lose weight over 24 months. Participants are divided into two groups: one receiving usual care and the other receiving intensive, remote support. This trial is suitable for Black or African American adults in Louisiana with obesity and Type II diabetes or pre-diabetes who are willing to change their diet and exercise habits. Participants must also have internet access and an active account with Ochsner Health System. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research in weight-loss methods.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it does exclude those currently using weight loss medication.

What prior data suggests that this intensive lifestyle intervention is safe for weight loss?

Research has shown that intensive lifestyle changes are generally safe for people. In one study, participants with type 2 diabetes who followed such a program lost a significant amount of weight over eight years, suggesting the approach is well-tolerated for long-term use. Another study found that these changes can be effective with remote support, such as phone calls, similar to what this trial offers.

Guidelines recommend this type of high-intensity program as a first step in managing obesity. The program usually focuses on reducing calorie intake and increasing physical activity. Although intensive, these changes are typically safe because they involve practical lifestyle adjustments rather than medications or surgeries.

In another study, adding a medication called tirzepatide to an intensive lifestyle program helped participants lose even more weight, demonstrating that lifestyle changes can be safely combined with other treatments if needed.

Overall, evidence suggests that intensive lifestyle changes are a safe way to manage weight, with few reports of serious side effects. This makes them a solid option for those looking to lose weight through sustainable changes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Intensive Lifestyle Intervention is unique because it leverages cutting-edge eHealth technology to deliver a comprehensive weight loss program remotely. Unlike standard care, which often involves sporadic check-ins with healthcare providers, this intervention offers a high-intensity schedule with weekly sessions initially, followed by monthly support. Health coaches from the Ochsner Health System use evidence-based strategies, including portion control and behavioral techniques, to guide participants. Researchers are excited because this approach could make effective weight loss support more accessible and personalized, potentially leading to better long-term outcomes.

What evidence suggests that this trial's treatments could be effective for weight loss?

Research has shown that significant lifestyle changes can lead to substantial weight loss. In this trial, participants in the Intensive Lifestyle Intervention arm will engage in a comprehensive, "high-intensity" program designed to support weight loss. One study found that half of the individuals with type 2 diabetes lost at least 5% of their body weight over eight years. Another study reported that individuals who were very overweight lost 13.1% of their weight after one year, although some weight was regained by the second year. This method typically aims for an initial steady weight loss of about 0.5 to 1 kilogram (about 1 to 2 pounds) per week. Overall, intensive lifestyle changes have proven effective in managing weight long-term. ^{1 2 3 4 6}

Who Is on the Research Team?

Peter T Katzmarzyk, PhD

Principal Investigator

Pennington Biomedical Research Center

Are You a Good Fit for This Trial?

This trial is for Black/African American residents of Louisiana aged 40-70 with Type II diabetes or pre-diabetes, obesity (BMI 30.0-50.0 kg/m2), and internet access. Participants must be willing to change their diet/activity and not be pregnant, in a weight loss program, have life-threatening diseases, past bariatric surgery, or recent significant weight loss.

Inclusion Criteria

I am between 40 and 70 years old.

My BMI is between 30.0 and 50.0.

Have weight measured at an Ochsner clinic within 4 weeks of screening

Exclusion Criteria

I have had bariatric surgery or plan to within 2 years.

You plan to move away from the area within the next 2 years.

My condition can worsen with exercise or weight loss.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a comprehensive, 'high-intensity' program delivered remotely using eHealth technology, with weekly sessions in the first six months followed by monthly sessions for the remaining 18 months

24 months

Weekly sessions for 6 months, then monthly sessions for 18 months

Follow-up

Participants are monitored for changes in various health metrics such as body weight, cholesterol levels, and blood pressure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intensive Lifestyle Intervention

Trial Overview

The study tests a remote intensive lifestyle intervention over 24 months for weight loss in primary care using technology. A health coach will guide patients through changes in diet and physical activity via an electronic medical record patient portal.

How Is the Trial Designed?

Group I: Intensive Lifestyle Intervention Experimental Treatment 1 Intervention

The intervention arm receives a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Obesity Guidelines, delivered remotely using eHealth technology, by trained health coaches embedded in the Digital Medicine Group in the Ochsner Health System. The intervention includes remote sessions with the health coach using evidence-based components such as the use of portion control and various behavioral strategies .Patients in the Intervention arm attend weekly sessions in the first six months, followed by monthly sessions for the remaining 18 months.

Group II: Usual Care Active Control 1 Intervention

Patients in the usual care arm will receive their normal, usual care from their primary care team.

Who Is Running the Clinical Trial?

Pennington Biomedical Research Center

Lead Sponsor

Trials

314

Recruited

183,000+

Ochsner Health System

Collaborator

Trials

97

Recruited

91,900+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

A new mathematical model was developed to predict weight changes based on dietary energy intake, using data from 8 longitudinal studies with 157 participants, which showed strong accuracy in its predictions (R² values of 0.83 and 0.91).

This model can help obese patients and their doctors set realistic long-term weight maintenance goals by calculating the necessary dietary changes, making it a practical tool for weight management professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling weight-loss maintenance to help prevent body weight regain. Hall, KD., Jordan, PN.[2023]

A 10-14 week inpatient intensive lifestyle intervention (ILI) for 100 severely obese individuals led to significant improvements in quality of life, including reductions in binge eating, anxiety, and depression, as well as enhancements in physical and mental health.

The study found that improvements in binge eating and physical health were directly associated with weight loss, indicating that the ILI not only helped participants lose weight but also positively impacted their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond weight reduction: improvements in quality of life after an intensive lifestyle intervention in subjects with severe obesity. Danielsen, KK., Sundgot-Borgen, J., Mæhlum, S., et al.[2015]

Both in-person and telephone group lifestyle interventions (LI) led to significantly greater weight loss compared to medical nutrition therapy (MNT) in patients with type 2 diabetes, with mean weight loss of 5.6% and 4.6% respectively at 6 months.

The cost-effectiveness of in-person LI was better than telephone LI, with an incremental cost of $789 per kilogram lost compared to $1223 for telephone LI, indicating that in-person programs may provide a more economical option for achieving weight loss in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Lifestyle Intervention for Type 2 Diabetes in Primary Care: the REAL HEALTH-Diabetes Randomized Clinical Trial. Delahanty, LM., Levy, DE., Chang, Y., et al.[2022]

Participants who maintained a weight loss of over 10% after an intensive lifestyle intervention showed significantly better cardiometabolic health outcomes compared to those with moderate weight loss or weight regain, including lower BMI, reduced fat composition, and improved blood markers like triglycerides and glucose levels.

The study involved 80 participants from a larger group of 2420, and it demonstrated that maintaining substantial weight loss is associated with enhanced metabolic health, suggesting that intensive lifestyle interventions can have meaningful long-term benefits for a subset of individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintaining a clinical weight loss after intensive lifestyle intervention is the key to cardiometabolic health. Dandanell, S., Skovborg, C., Præst, CB., et al.[2022]

In the Look AHEAD trial, severely obese participants (BMI ≥40 kg/m²) who underwent an intensive lifestyle intervention (ILI) lost an average of 9.04% of their initial body weight after one year, which was significantly more than the 7.43% weight loss in overweight participants, showing that ILI is effective for severe obesity.

All groups, including severely obese participants, showed similar improvements in cardiovascular disease risk factors such as fitness, LDL cholesterol, and blood pressure, indicating that intensive lifestyle changes can benefit individuals regardless of their initial weight category.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of lifestyle interventions for individuals with severe obesity and type 2 diabetes: results from the Look AHEAD trial. Unick, JL., Beavers, D., Jakicic, JM., et al.[2022]

In a study of 199 morbidly obese patients undergoing a 1-year intensive lifestyle intervention, the average weight loss was 10 kg, with significant predictors of weight loss including the amount lost at 12 weeks, age, and occupational status.

Factors such as adherence to a weight loss diary, absence of type 2 diabetes, and regular follow-ups with general practitioners positively influenced weight loss outcomes at the 12-week mark, which in turn predicted greater weight loss after one year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of weight loss after an intensive lifestyle intervention program in obese patients: a 1-year prospective cohort study. Karlsen, TI., Søhagen, M., Hjelmesæth, J.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3904491/

Eight-Year Weight Losses with an Intensive Lifestyle ...

Look AHEAD's ILI produced clinically meaningful weight loss (≥5%) at year 8 in 50% of patients with type 2 diabetes and can be used to manage other obesity- ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3574274/

The long-term effectiveness of a lifestyle intervention in ...

Severely obese individuals who completed the program achieved a 13.1% weight loss at 1 year and regained approximately one-quarter of lost weight by Year 2 (9.6 ...

3.

gastrojournal.org

gastrojournal.org/article/S0016-5085(17)30139-7/fulltext

Intensive Lifestyle Intervention for Obesity

Comprehensive interventions are designed to induce a weight loss of approximately 0.5–1 kg per week for the first 12 weeks, with more gradual weight loss ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06321809

Intensive Lifestyle Interventions to Overweight and Obese ...

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

5.

nature.com

nature.com/articles/s41591-023-02597-w

Tirzepatide after intensive lifestyle intervention in adults ...

Tirzepatide provided substantial additional reduction in body weight in participants who had achieved ≥5.0% weight reduction with intensive lifestyle ...

6.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa1212914

Cardiovascular Effects of Intensive Lifestyle Intervention in ...

An intensive lifestyle intervention focusing on weight loss did not reduce the rate of cardiovascular events in overweight or obese adults with type 2 diabetes.