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Recruiting NCT06532747

Redefining BMI: The Body, Mind, and Inflammation Trial

No phase Interventional Obesity Adiposity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Integrated Lifestyle Intervention (ILI), Monitoring with digital tools.
Who it may be relevant to
Registry conditions: Obesity, Adiposity. Basic parameters: 18 years — 25 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

This is a 2-arm, parallel randomized controlled pilot trial designed to test the preliminary efficacy of a novel integrated lifestyle intervention for emerging adult (EA) women, compared to a developmentally adapted behavioral weight loss arm. Thirty-two participants (female, 18-25 years, BMI 25-50 kg/m\^2) will be randomized to 1 of 2 arms: 1) Integrated Lifestyle Intervention (ILI); or 2) Behavioral Weight Loss (BWL). The primary goals are to test the preliminary efficacy of ILI to reduce adiposity over 12 months compared to BWL, and to test the preliminary efficacy of ILI to improve biomarkers of inflammation and cardiometabolic risk over 12 months compared with BWL. Assessments of adiposity, inflammatory cytokines, cardiovascular disease (CVD) risk factors, and behavioral and psychological treatment targets will occur at 0, 4, 8 and 12 months. In addition, putative psychological mechanisms of action will be explored to inform a future trial.

Interventions

  • Behavioral Integrated Lifestyle Intervention (ILI)
    ILI 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.
  • Behavioral Monitoring with digital tools
    All 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.

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 [Time frame: 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 [Time frame: 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 [Time frame: Change in % body fat at 4, 8, and 12-months.]
Secondary outcome measures (8)
  • 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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 [Time frame: 4, 8, and 12-months]
  • Change in cholesterol level at 4, 8, and 12-months. [Time frame: 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. [Time frame: 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. [Time frame: 4, 8, and 12-months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Virginia Commonwealth Universtity — Richmond

Identifiers

NCT: NCT06532747 · HM20028726 · 5R01DK137998

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗