About this trial
Emerging adulthood (18-25 years of age) is a critical developmental window to promote weight management and cardiometabolic health, particularly for emerging adult women. The primary purpose of this study is to test the preliminary efficacy of the intensive lifestyle intervention for EA women in reducing adiposity, as well as improving biomarkers of inflammation and metabolic risk over 12 months compared with a traditional behavioral weight loss intervention. This treatment program will be tested in emerging adult (EA) women ages 18-25 years old with a BMI of 25-50 kg/m\^2.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 18-25 years
Body mass index (BMI) 25-50 kg/m²
Female
Disqualifiers
Currently pregnant or lactating
Current involvement in a weight loss program or current use of weight loss medication
Lost >5% of their body weight in the previous 3 months
Uncontrolled medical conditions that may pose a safety issue given the recommendations for the diet and unsupervised physical activity
Trial design
Parallel
Treatments tested in this trial
Integrated Lifestyle Intervention (ILI)
BehavioralILI participants will receive training in empirically supported strategies to improve psychological function (e.g., restructuring negative thoughts, distress tolerance), with a focus on changing discrete behaviors linked to inflammation (e.g., sleep, processed foods, physical activity), all intertwined with BWL content adapted to meet the needs of EAs.
Monitoring with digital tools
BehavioralAll participants will receive digital tools to facilitate self-monitoring-the initial 4-month program will consist of group sessions via Zoom (8 weekly, 4 bi-weekly) with weekly tailored e-coaching, followed by monthly boosters through 12 months.
Treatment groups
Trial outcomes
Primary outcomes
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
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
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
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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Virginia Commonwealth University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator