Redefining BMI: The Body, Mind, and Inflammation Trial
NCT Number: NCT06532747
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity|Adiposity
Interventions: BEHAVIORAL: Integrated Lifestyle Intervention (ILI)|BEHAVIORAL: Monitoring with digital tools
Sponsor: Virginia Commonwealth University
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sex: FEMALE
Age: ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-10
Completion Date: 2026-04
Locations: Virginia Commonwealth Universtity, Richmond, Virginia, 23298, United States

Summary:
Emerging adulthood (18-25 years of age) represents a critical developmental window for promoting cardiometabolic health given high rates of obesity, proinflammatory behaviors, life stressors, and psychological symptoms-all of which perpetuate chronic low-level inflammation, thereby increasing cardiometabolic risk. Furthermore, the prevalence of obesity among emerging adults (EA) has increased five-fold over the last 4 decades-over half of EAs meet criteria for overweight or obesity. Yet, very few behavioral obesity management trials focus specifically on EAs. Those that do have produced modest treatment effects, with EA women experiencing considerably less benefit than EA men-a pattern even more pronounced for Black and Latina EA women. Thus, efforts are urgently needed to enhance behavioral obesity treatment outcomes among EA women.

Primary Outcome Measures: To test the preliminary efficacy of the intensive lifestyle intervention for EA women in reducing adiposity over 12 months compared with BWL, Change in adiposity (weight) between the two treatment arms across 12-months, Change in weight at 4, 8, and 12-months|To test the preliminary efficacy of the intensive lifestyle intervention for EA women in reducing waist circumference over 12 months compared with BWL, Change in adiposity (waist circumference) between the two treatment arms across 12-months, Change in waist circumference at 4, 8, and 12-months.|To test the preliminary efficacy of the intensive lifestyle intervention for EA women in reducing % body fat over 12 months compared with BWL, Change in adiposity (% body fat) between the two treatment arms across 12-months, Change in % body fat at 4, 8, and 12-months.
Secondary Outcome Measures: To test the preliminary efficacy of ILI to improve biomarkers of inflammation and cardiometabolic risk over 12 months compared with BWL examining Change in serum IL-1β and IL-6 at 4, 8, and 12-months., Change in serum IL-1β and IL-6. Bursts of IL-1β can indicate acute inflammation, myocardial infarction, or stroke. IL-1β can also trigger the expression of IL-6 in various cell types. Elevated IL-6 levels can indicate an inflammatory condition, such as rheumatoid arthritis, lupus, or other autoimmune disorders. IL-6 levels can also correlate with disease activity., 4, 8, and 12-months|To test the preliminary efficacy of ILI to improve biomarkers of inflammation and cardiometabolic risk over 12 months compared with BWL examining Change in serum TNF-α at 4, 8, and 12-months., Change in serum TNF-α. A systematic review and meta-analysis found that patients with T1DM had significantly higher serum TNF-α levels than controls. TNF-α levels were also correlated with age, disease duration, and ethnicity., 4, 8, and 12-months|To test the preliminary efficacy of ILI to improve biomarkers of inflammation and cardiometabolic risk over 12 months compared with BWL examining Change in CRP at 4, 8, and 12-months., Change in CRP. Factors that can cause CRP levels to be slightly higher than normal include obesity, lack of exercise, cigarette smoking, diabetes, cancer, heart attack, inflammatory bowel disease (IBD), rheumatoid arthritis, lupus, and related diseases, and rheumatic fever., 4, 8, and 12-months|To test the preliminary efficacy of ILI to improve biomarkers of inflammation and cardiometabolic risk over 12 months compared with BWL examining Change in free cortisol at 4, 8, and 12-months., Change in free cortisol, The normal range for adults is 3.5-45 micrograms per 24 hours, but this can vary by age. Factors that can affect free cortisol levels include: Stress, Alcoholism, Depression., 4, 8, and 12-months|To test the preliminary efficacy of ILI to improve biomarkers of inflammation and cardiometabolic risk over 12 months compared with BWL examining Change in HOMA-IR at 4, 8, and 12-months, Change in HOMA-IR, HOMA-IR measures the insulin level needed in the blood to maintain normal sugar levels. This test helps diagnose insulin resistance, the early stage of type 2 diabetes, a condition that increases the risks of several chronic health conditions., 4, 8, and 12-months|Change in cholesterol level at 4, 8, and 12-months., Change in lipids, Lipid disorders can lead to serious health problems, such as heart disease and stroke, because they prevent the body from properly metabolizing fats. High levels of certain lipids, especially cholesterol, can also lead to long-term problems like atherosclerosis., 4, 8, and 12-months|To test the preliminary efficacy of ILI to improve biomarkers of inflammation and cardiometabolic risk over 12 months compared with BWL examining Change in ALT/AST at 4, 8, and 12-months., Change in ALT/AST (Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)) There are many causes of mildly elevated ALT and AST levels. The most common causes are nonalcoholic fatty liver disease (NAFLD) and alcoholic liver disease. In NAFLD, the liver has more fatty tissue in it than normal., 4, 8, and 12-months|To test the preliminary efficacy of ILI to improve biomarkers of inflammation and cardiometabolic risk over 12 months compared with BWL examining Change in systolic and diastolic blood pressure at 4, 8, and 12-months., Change in systolic and diastolic blood pressure. Your systolic and diastolic pressures change depending on your activity level, stress, fluid intake, and other factors. It's important to limit how these other factors might change your pressure when you're taking a blood pressure reading., 4, 8, and 12-months