The BMI Project (Body, Mind, Inflammation)

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04023318
• Other study ID #: MCC-18-14509
• Secondary ID: HM20015075NCI-20
• Status: Completed
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: June 18, 2021

Study information

• Verified date: May 2022
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 18, 2021
• Est. primary completion date: June 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 25 years

• Body Mass Index between 25 and 45 kg/m2

Exclusion Criteria:

• Currently pregnant or lactating; pregnancy in the last 6 months or plans to become pregnant in the next 6 months

• Type 1 or type 2 diabetes

• Any uncontrolled medical conditions that could make it unsafe to participate in unsupervised exercise

• Medical conditions associated with chronic inflammation

• Inability to read, understand and speak English

Related Conditions & MeSH terms

• Chronic Inflammation
• Inflammation
• Obesity
• Overweight
• Overweight and Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of sessions attended throughout the intervention period	Attendance at in-person treatment sessions is one critical metric for demonstrating feasibility and will be tracked throughout the intervention period.	4 months
Primary	Number of days self-monitoring weight in LoseIt	Self-monitoring of weight is a critical metric for demonstrating feasibility and will be tracked throughout the intervention period.	4 months
Primary	Number of days self-monitoring weight-related behaviors in LoseIt	Self-monitoring of weight-related behaviors (e.g., diet and physical activity) is a critical metric for demonstrating feasibility and will be tracked throughout the intervention period.	4 months
Secondary	Change in diet	Dietary change will be assessed using the Diet History Questionnaire III (DHQ-III), a 166-item adaptive questionnaire developed by NCI which maps on to dietary intervention targets (e.g., saturated fat, alcohol, sugar, fiber, sodium), as well as a measure of overall diet.	Baseline and 4 months
Secondary	Change in physical activity	Participants will report their physical activity using the 6-item Paffenbarger Physical Activity Questionnaire, which yields estimates of minutes spent in moderate-to-vigorous physical activity.	Baseline and 4 months
Secondary	Change in sleep	The EARLY Trials Common Elements Sleep Questionnaire (8 items) will be administered that asks about duration of sleep and problems encountered during sleep (e.g. snoring).	Baseline and 4 months
Secondary	Percent Weight Change	Weight will be measured in light clothes, without shoes, on calibrated Tanita BWB-800S scales. Percent change of initial body weight will be calculated using baseline and 4 month weights.	Baseline and 4 months