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The BMI Project (Body, Mind, Inflammation)

Virginia Commonwealth University (VCU) logo

Virginia Commonwealth University (VCU)

Status

Completed

Conditions

Chronic Inflammation
Overweight and Obesity

Treatments

Behavioral: Integrated Lifestyle Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04023318
HM20015075 (Other Identifier)
NCI-2019-04792 (Other Identifier)
MCC-18-14509

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18 to 25 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

19 participants in 1 patient group

Integrated Lifestyle Intervention
Experimental group
Treatment:
Behavioral: Integrated Lifestyle Intervention

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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