The BMI Project (Body, Mind, Inflammation)

Not Applicable

Completed

• Conditions: Overweight and Obesity; Chronic Inflammation
• Interventions: Behavioral: Integrated Lifestyle Intervention

• Registration Number: NCT04023318
• Lead Sponsor: Virginia Commonwealth University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-15
• Study First Submitted: 2019-07-15
• Study First Submitted QC: 2019-07-15
• Study First Posted: 2019-07-17
• Primary Completion: 2021-06-18
• Study Completion: 2021-06-18
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Integrated Lifestyle Intervention	Integrated Lifestyle Intervention	-

Primary Outcome Measures

Name	Time	Method
Number of sessions attended throughout the intervention period	4 months	Attendance at in-person treatment sessions is one critical metric for demonstrating feasibility and will be tracked throughout the intervention period.
Number of days self-monitoring weight-related behaviors in LoseIt	4 months	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.
Number of days self-monitoring weight in LoseIt	4 months	Self-monitoring of weight is a critical metric for demonstrating feasibility and will be tracked throughout the intervention period.

Secondary Outcome Measures

Name	Time	Method
Change in sleep	Baseline and 4 months	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).
Percent Weight Change	Baseline and 4 months	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.
Change in diet	Baseline and 4 months	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.
Change in physical activity	Baseline and 4 months	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.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States