Clinical trial NCT04023318: The BMI Project (Body, Mind, Inflammation)
Official title: A Novel Integrated Lifestyle Intervention to Reduce Obesity and Inflammation Among Emerging Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Chronic Inflammation
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of sessions attended throughout the intervention period
timeFrame: 4 months
measure: Number of days self-monitoring weight in LoseIt
timeFrame: 4 months
measure: Number of days self-monitoring weight-related behaviors in LoseIt
timeFrame: 4 months
Secondary outcomes:
measure: Change in diet
timeFrame: Baseline and 4 months
measure: Change in physical activity
timeFrame: Baseline and 4 months
measure: Change in sleep
timeFrame: Baseline and 4 months
measure: Percent Weight Change
timeFrame: Baseline and 4 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Jessica LaRose, PhD
role: PRINCIPAL_INVESTIGATOR
References: