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NCT04023318 · ClinicalTrials.gov registry record · NA

The BMI Project (Body, Mind, Inflammation)

A NA study, sponsored by Virginia Commonwealth University.

Completed
Registry status
NA
Development phase
19
Enrollment target

NCT04023318: Completed NA study, sponsored by Virginia Commonwealth University.

NCT04023318 is a NA study that has completed, run by Virginia Commonwealth University. The registered enrollment target is 19 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04023318, a NA study, has completed, sponsored by Virginia Commonwealth University.

COMPLETED
Registry status
NA
Development phase
19 participants
Enrollment target

Study 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.

Primary Outcome

Attendance at in-person treatment sessions is one critical metric for demonstrating feasibility and will be tracked throughout the intervention period.

Interventions

  • BEHAVIORAL Integrated Lifestyle Intervention

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2019-07-15
Est. Completion 2021-06-18
Phase NA
Virginia Commonwealth University

558 total trials

What the finished NCT04023318 record still lists

NCT04023318 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Integrated Lifestyle Intervention is the first listed.

NCT04023318 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04023318 about?

NCT04023318 is a clinical study titled "The BMI Project (Body, Mind, Inflammation)". 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 ...

What is the current status of trial NCT04023318?

This trial is currently completed. It is a NA study. The enrollment target is 19 participants. The study started on 2019-07-15. Estimated completion is 2021-06-18.

What interventions are being tested in trial NCT04023318?

The interventions under investigation include: Integrated Lifestyle Intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT04023318?

This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04023318's enrollment target sits among peer trials

19 1861st of 2000 higher than 138 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04023318, the US trial registry maintained by the National Library of Medicine. NCT04023318 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.