The BMI Project (Body, Mind, Inflammation)

NCT04023318 | Completed

• 3 other identifiers: MCC-18-14509HM20015075NCI-2019-04792
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity; Chronic Inflammation

Outcome Measures

Primary Outcomes (3)

• 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.

  4 months

• 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.

  4 months

• 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.

  4 months

Secondary Outcomes (4)

• Change in diet

  Baseline and 4 months

• Change in physical activity

  Baseline and 4 months

• Change in sleep

  Baseline and 4 months

• Percent Weight Change

  Baseline and 4 months

Study Arms (1)

Integrated Lifestyle Intervention

EXPERIMENTAL

Behavioral: Integrated Lifestyle Intervention

Interventions

Integrated Lifestyle Intervention BEHAVIORAL

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.

Integrated Lifestyle Intervention

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 25 years
• Body Mass Index between 25 and 45 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jessica LaRose, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 17, 2019
• Study Start: July 15, 2019
• Primary Completion: June 18, 2021
• Study Completion: June 18, 2021
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)