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Clinical Trials/NCT04023318
NCT04023318
Completed
Not Applicable

A Novel Integrated Lifestyle Intervention to Reduce Obesity and Inflammation Among Emerging Adults

Virginia Commonwealth University1 site in 1 country19 target enrollmentJuly 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Overweight and Obesity
Sponsor
Virginia Commonwealth University
Enrollment
19
Locations
1
Primary Endpoint
Number of sessions attended throughout the intervention period
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2019
End Date
June 18, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Number of sessions attended throughout the intervention period

Time Frame: 4 months

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-related behaviors in LoseIt

Time Frame: 4 months

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.

Number of days self-monitoring weight in LoseIt

Time Frame: 4 months

Self-monitoring of weight is a critical metric for demonstrating feasibility and will be tracked throughout the intervention period.

Secondary Outcomes

  • Change in sleep(Baseline and 4 months)
  • Percent Weight Change(Baseline and 4 months)
  • Change in diet(Baseline and 4 months)
  • Change in physical activity(Baseline and 4 months)

Study Sites (1)

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