Redefining BMI: The Body, Mind, and Inflammation Trial

Launched by VIRGINIA COMMONWEALTH UNIVERSITY · Jul 31, 2024

Keywords

ClinConnect Summary

The "Redefining BMI: The Body, Mind, and Inflammation Trial" is a research study aimed at helping young women aged 18 to 25 who are dealing with obesity. This study will compare two different programs to see which one better helps participants reduce body fat and improve their health over a year. One program is an intensive lifestyle intervention that includes personalized guidance on diet and exercise, while the other is a more traditional weight loss approach. By focusing on this age group, the study hopes to make a positive impact on their overall health and well-being during a key period in their lives.

To be eligible for this trial, participants must be females aged 18-25 with a body mass index (BMI) between 25 and 50, which indicates they are overweight or obese. However, some individuals may not qualify if they are currently pregnant, using weight loss medications, or have certain health conditions that could complicate their participation. If eligible, participants can expect to receive support and resources to help them improve their lifestyle and health, while also contributing to important research that could benefit others in their community.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Ages 18-25 years
• • Body mass index (BMI) 25-50 kg/m\^2
• • Female
• Exclusion Criteria:
• • 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
• • Diagnosis of type 2 diabetes and/or impaired fasting blood glucose
• • Diagnosis of type 1 diabetes
• • Rheumatologic and gastrointestinal conditions associated with severe systemic inflammation
• • Medical conditions resulting in known perturbations in the hypothalamic-pituitary-adrenal axis
• • Report of a heart condition, chest pain during periods of activity or rest, or loss of consciousness
• • Current or recent (during the past 3 months) use of medications that may impact weight or metabolic function
• • Current or recent (during the past 3 months) use of anti-inflammatory medications
• • Report of diagnosis or history of Anorexia Nervosa or Bulimia Nervosa, or any compensatory behaviors within the previous 3 months
• • Hospitalization for depression or other psychiatric disorder within the past 12 months
• • Uncontrolled bipolar disorder or psychotic disorder
• • Current suicidal intent
• • Planning to move from the area within the study period
• • Unwilling to be randomized to either study condition
• • Unable to read and speak English