Virginia Commonwealth University
Richmond, Virginia, 23219, United States
NCT Number: NCT04023318
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.
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Notify Me18 year–25 year
All sexes
Interventional
Not applicable
Richmond, Virginia, 23219, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 4 months
Self-monitoring of weight is a critical metric for demonstrating feasibility and will be tracked throughout the intervention period.
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.
Time frame: Baseline and 4 months
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
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
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
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.
Virginia Commonwealth University
Other
A Novel Integrated Lifestyle Intervention to Reduce Obesity and Inflammation Among Emerging Adults
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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