Intensive Lifestyle Intervention for Weight Loss

(PROPEL-IT 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.

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

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.

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.

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.¹²³⁴⁶