Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT06636058
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
74 Years
Study:
NCT06636058
Study Brief:
Protocol Section:
NCT06636058