NCT04023318

The BMI Project (Body, Mind, Inflammation)

A Novel Integrated Lifestyle Intervention to Reduce Obesity and Inflammation Among Emerging Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

Obesity and chronic inflammation influence the development and progression of many types of cancer. These conditions share several of the same causes, including physical inactivity, poor nutrition, stress, and insufficient sleep. Emerging adulthood (ages 18-25) represents an important developmental period in which to address behaviors and psychological variables that affect both weight status and inflammation. At least 40% of emerging adults have overweight/obesity, and this transition from adolescence to early adulthood is associated with significant increases in fast food consumption, decreases in physical activity, unpredictable sleep schedules, and alarmingly high rates of depression and perceived stress. Despite this high risk for obesity, very few weight loss interventions are designed specifically for emerging adults. Preliminary findings from weight loss interventions targeting this population have shown some promise, but generally produce modest outcomes with less consistent effects than programs in older adults. Depression and stress have been found to interfere with weight loss among emerging adults, and may be in part responsible for poorer outcomes. This proposal will develop and test an Integrated Lifestyle Intervention (ILI) that comprehensively addresses both psychological distress and traditional weight management targets. This novel approach has not been tested before and has the potential not only to enhance weight loss outcomes in this high risk population, but also to produce reductions in markers of inflammation beyond those achievable by weight loss alone.

Conditions

• Overweight and Obesity
• Chronic Inflammation

Interventions

Type	Name	Description
BEHAVIORAL	Integrated Lifestyle Intervention	This program is grounded in data demonstrating the dysregulation across multiple domains and considerable life stressors experienced by this population. The central hypothesis is that by simultaneously ameliorating psychological dysregulation and directly targeting proinflammatory behaviors, ILI operates on multiple proposed mediators of poor treatment outcomes in this population, thereby enhancing treatment outcomes. As such, the overall framework emphasizes integration of self-regulation as it applies to both psychological functioning and weight control. Content will highlight the interconnectedness of mood, stress, eating and exercise behaviors, and risk for inflammation and disease. Each treatment session will present a combination of behavioral and psychological content, representing a truly integrated approach. Participants will meet for 75-minute group sessions weekly for months 1-2, followed by bi-weekly groups in months 3-4, for a total of 12 groups.

Timeline

• Start date: 2019-07-15
• Primary completion: 2021-06-18
• Completion: 2021-06-18
• First posted: 2019-07-17
• Last updated: 2022-05-11

Locations

1 site across 1 country: United States