BridgeMD
New treatment option for Obesity
Official title Digital InteGrated Behavioral TreatmeNt for Comorbid ObesITy and DeprEssion Among Racial and Ethnic Adults Age 50 and Older
ClinicalTrials.gov ID: NCT06636058
What this study is testing
- What it's testing
- The goal of this randomized clinical trial is to test the efficacy of a fully digital intervention, combining the Lumen problem-solving therapy virtual coach for depression management with the Diabetes Prevention Program video-based program for weight loss, among racial and ethnic minorities with comorbid depression and obesity. The study aims include: Determine the efficacy of the vCare intervention at 6 months.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 74
You may be able to join if
- Age 50-74 years (inclusive)
- Confirmed body mass index (BMI) between ≥27.0 and \<45.0 based on weight and height measured by study staff at device distribution
- Confirmed weight ≤396 lbs
- Patient Health Questionnaire-9 (PHQ-9) scores between ≥10 and \<20, indicating moderate to moderately severe depressive symptoms
- Self-identified race and ethnicity other than non-Hispanic White
You likely can't join if
- Unable to speak, read, understand English sufficiently for informed consent
- No reliable Wi-Fi Internet access at home
- Pre-existing type 1 or type 2 diabetes, coronary heart disease, heart failure, stroke, cancer diagnosis (other than non-melanoma skin cancer) or...
- Self-report of weight change \>15 lbs. during prior 3 months
- Current active weight loss treatment, including research-based commercial weight loss programs (e.g., Weight Watchers, Jenny Craig, HMR, Omada...
- Taking prescription medications regularly that affect appetite/weight (e.g., anti-obesity medicines, oral corticosteroids, oral hypoglycemics, etc.)...
See the full eligibility criteria
- Age 50-74 years (inclusive)
- Confirmed body mass index (BMI) between ≥27.0 and \<45.0 based on weight and height measured by study staff at device distribution
- Confirmed weight ≤396 lbs
- Patient Health Questionnaire-9 (PHQ-9) scores between ≥10 and \<20, indicating moderate to moderately severe depressive symptoms
- Self-identified race and ethnicity other than non-Hispanic White
- Willing and able to accept randomization, and provide informed e-consent and HIPAA authorization
- Unable to speak, read, understand English sufficiently for informed consent
- No reliable Wi-Fi Internet access at home
- Pre-existing type 1 or type 2 diabetes, coronary heart disease, heart failure, stroke, cancer diagnosis (other than non-melanoma skin cancer) or treatment in the past 12 months, end-stage organ failure, residence in a...
- Self-report of weight change \>15 lbs. during prior 3 months
- Current active weight loss treatment, including research-based commercial weight loss programs (e.g., Weight Watchers, Jenny Craig, HMR, Omada, TOPS), other programs led by trained personnel (professional or lay) at the...
- Taking prescription medications regularly that affect appetite/weight (e.g., anti-obesity medicines, oral corticosteroids, oral hypoglycemics, etc.) for chronic disease management
- Planned or prior bariatric surgery (Note: patients who are more than 2 years post bariatric surgery may otherwise be eligible)
- Screen positive for bulimia nervosa using PHQ- eating disorder module
- Unable to pass the Revised Physical Activity Readiness Questionnaire (PAR-Q) or obtain physician clearance to participate
- Active suicidal ideation (PHQ-9 item 9 score ≥1 or SCL-20 item 2 score ≥2) with active plan and/or intent
- Bipolar or psychotic disorder, or pharmacotherapy or psychotherapy (individual or professionally-led group therapy), or brain stimulation therapy for depression or any other psychiatric condition
- Cognitive impairment based on the Callahan 6-item screener
- Active alcohol or substance use disorder (including prescription drugs) based on the CAGE Questionnaire Adapted to Include Drugs (CAGE-AID)
- Current or planned pregnancy or lactating (\<6 months postpartum)
- Participation in other behavioral, medical or surgical treatment studies by self-report that conflict with the primary weight loss and depression outcomes of this study
- Family/household member of an already enrolled participant or of a study team member
- Investigator discretion for serious safety or protocol adherence reasons
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.