Digital InteGrated Behavioral TreatmeNt for Comorbid ObesITy and DeprEssion Among Racial and Ethnic Adults Age 50 and Older

Launched by UNIVERSITY OF ILLINOIS AT CHICAGO · Oct 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new digital program designed to help adults aged 50 and older who are dealing with both obesity and depression. The program combines a virtual coach to help manage depression with a video-based weight loss program. Researchers want to see if this digital approach can effectively help participants lose weight and reduce their depression symptoms over six months. They will also look at what factors might help someone succeed in this program and gather feedback about participants' experiences.

To join the study, participants need to be between 50 and 74 years old, have a body mass index (BMI) of 27 or higher, and show moderate depression symptoms. They should also identify as a racial or ethnic minority and have access to the internet. Participants will be randomly assigned to either start the program right away or wait for six months before starting. Throughout the study, they will have regular check-ins to monitor their progress. This trial is currently recruiting participants who meet these criteria, so if you or someone you know fits this description, it could be a good opportunity to receive support for both weight loss and mental health.

Gender

ALL

Eligibility criteria

• • Inclusion 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
• • Exclusion Criteria
• • 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 long-term care facility, life expectancy \<24 months
• • 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 recruiting clinic or in the local community
• • 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