Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
32 participants
INTERVENTIONAL
2025-09-26
2027-03-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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.
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.
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 Weight Loss (BWL)
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) 25-50 kg/m\^2
* Female
Exclusion Criteria
* 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
18 Years
25 Years
FEMALE
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Jessica LaRose
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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Virginia Commonwealth Universtity
Richmond, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HM20028726
Identifier Type: -
Identifier Source: org_study_id