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The BMI Project (Body, Mind, Inflammation)

Primary Purpose

Overweight and Obesity, Chronic Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integrated Lifestyle Intervention
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Integrated Lifestyle Intervention

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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).
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.

Full Information

First Posted
July 15, 2019
Last Updated
May 5, 2022
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT04023318
Brief Title
The BMI Project (Body, Mind, Inflammation)
Official Title
A Novel Integrated Lifestyle Intervention to Reduce Obesity and Inflammation Among Emerging Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
June 18, 2021 (Actual)
Study Completion Date
June 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Chronic Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrated Lifestyle Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Integrated Lifestyle Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of sessions attended throughout the intervention period
Description
Attendance at in-person treatment sessions is one critical metric for demonstrating feasibility and will be tracked throughout the intervention period.
Time Frame
4 months
Title
Number of days self-monitoring weight in LoseIt
Description
Self-monitoring of weight is a critical metric for demonstrating feasibility and will be tracked throughout the intervention period.
Time Frame
4 months
Title
Number of days self-monitoring weight-related behaviors in LoseIt
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Change in diet
Description
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.
Time Frame
Baseline and 4 months
Title
Change in physical activity
Description
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.
Time Frame
Baseline and 4 months
Title
Change in sleep
Description
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).
Time Frame
Baseline and 4 months
Title
Percent Weight Change
Description
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.
Time Frame
Baseline and 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica LaRose, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The BMI Project (Body, Mind, Inflammation)

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