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ObesityNCT06532747

Redefining BMI: The Body, Mind, and Inflammation Trial

A study testing Integrated Lifestyle Intervention (ILI) and Monitoring with digital tools in people with Obesity and Adiposity, run by Virginia Commonwealth University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 25 years, women only
Conditions the study is for
Obesity, Adiposity
What is being tested?
Integrated Lifestyle Intervention (ILI) and Monitoring with digital tools
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
26 Sep 2025to 3 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Ages 18-25 years
  • Body mass index (BMI) 25-50 kg/m^2
  • Female

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vivian Hunter contact

(804) 628-3972

huntervr@vcu.edu

Jessica LaRose contact

(804) 628-7521

jlarose@vcu.edu

United States1 site, 1 recruiting

  • Virginia Commonwealth Universtity

    Richmond, Virginia, 23298

    Vivian Hunter, MS, 804-628-3972, huntervr@vcu.edu

    Jessica LaRose, (804) 628-7521, jlarose@vcu.edu

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Conditions
Obesity, Adiposity
Being tested
Integrated Lifestyle Intervention (ILI), Monitoring with digital tools
Keywords
BMI, Emerging Adult (EA) Women, Lifestyle Intervention, Biomarker Inflammation Improvement
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integrated Lifestyle Intervention (ILI)Behavioural

    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.

  • Monitoring with digital toolsBehavioural

    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.

Study groups in NCT06532747
Study groupRoleWhat they receive
Integrated Lifestyle Intervention (ILI)ExperimentalILI 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. 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.
Receives: Behavioral: Integrated Lifestyle Intervention (ILI)
Behavioral Weight Loss (BWL)ExperimentalAll 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.
Receives: Behavioral: Integrated Lifestyle Intervention (ILI); Behavioral: Monitoring with digital tools

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Change in weight at 4, 8, and 12-months

  2. 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

    Measured: Change in waist circumference at 4, 8, and 12-months.

  3. 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

    Measured: Change in % body fat at 4, 8, and 12-months.

Secondary outcomes (8)

  1. 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.

    Measured: 4, 8, and 12-months

  2. 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.

    Measured: 4, 8, and 12-months

  3. 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.

    Measured: 4, 8, and 12-months

  4. 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.

    Measured: 4, 8, and 12-months

  5. 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.

    Measured: 4, 8, and 12-months

  6. 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.

    Measured: 4, 8, and 12-months

  7. 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.

    Measured: 4, 8, and 12-months

  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 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.

    Measured: 4, 8, and 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2024
  2. Study start26 Sep 2025
  3. Primary completion3 Mar 2027 (estimated)
  4. Study completion3 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model 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.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06532747
Sponsor's protocol ID
HM20028726
Other IDs
5R01DK137998
Status last verified
May 2026
First submitted
29 Jul 2024
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Integrated Lifestyle Intervention (ILI) and Monitoring with digital tools in people with Obesity and Adiposity, run by Virginia Commonwealth University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vivian Hunter ((804) 628-3972, huntervr@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06532747.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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