Clinical trial NCT06636058: Digital InteGrated Behavioral TreatmeNt for Comorbid ObesITy and DeprEssion Among Racial and Ethnic Adults Age 50 and Older
Official title: Digital InteGrated Behavioral TreatmeNt for Comorbid ObesITy and DeprEssion Among Racial and Ethnic Adults Age 50 and Older (IGNITE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Depression
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
name: National Institute on Aging (NIA)
First posted: 2024-10-10
Enrollment: 440
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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. Primary outcomes are weight and depression symptom checklist 20-item (SCL-20) score.
* Identify predictors of treatment success, defined by achieving clinically significant weight loss (5%) and depression outcomes (50% decline or SCL-20\<0.5), at 6 and 12 months.
* Characterize participant experiences and perceptions of the vCare intervention. Eligible participants will be randomized to the early-intervention arm who will receive active treatment for 6 months, followed by maintenance for another 6 months, or the later-intervention arm who will be waitlisted for 6 months and then receive active treatment in the second 6 months.

Detailed description: The objective of this project is to test the efficacy of a fully digital intervention, combining the Lumen problem-solving treatment (PST) virtual coach for depression management with the Diabetes Prevention Program (DPP) video-based program for weight loss. This integrated intervention is named vCare. Patients self-identified as a racial or ethnic minority with depression and obesity will be enrolled from a large minority-serving academic medical center in Chicago.

In this fully remote clinical trial, participants will receive a study iPad, a wireless weight scale, and a wearable activity tracker. Eligible participants who complete baseline assessment (N=440) will be randomly assigned in 1:1 ratio to receive the vCare intervention early (for 6 months of active treatment and 6 months of maintenance) or later (for 6 months waitlist control and 6 months of active treatment). Participants in either the early- or later-intervention arm will be assessed at 6 and 12 months follow-up.

The specific aims of this study are to (1) determine the intervention efficacy to improve the primary depressive symptoms and weight loss outcomes and secondary outcomes (e.g., anxiety, sleep, quality of life, social isolation, loneliness, and psychosocial and cognitive functioning) at 6 months; (2) identify predictors of treatment success, defined by clinically significant weight loss (5%) and depression response (50% symptom reduction) or remission (free of symptoms), at 6 and 12 months; and (3) characterize the experiences and perceptions of intervention participants to inform future adaptation and translation.

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

Primary outcomes:
measure: Changes in weight from baseline to 6 months
timeFrame: From Baseline to 6 months
measure: Changes in Depression Symptom Checklist 20-items (SCL-20) from baseline to 6 months
timeFrame: From Baseline to 6 months
Secondary outcomes:
measure: Changes in weight from baseline to 12 months
timeFrame: From Baseline to 12 months
measure: Changes in Depression Symptom Checklist 20-items (SCL-20) from baseline to 12 months
timeFrame: From Baseline to 12 months
measure: Clinically significant weight change from baseline
timeFrame: From baseline to 6 months, 12 months
measure: Depression Response
timeFrame: From baseline to 6 months, 12 months
measure: Depression Remission
timeFrame: Baseline, 6 months, 12 months
measure: Changes in Generalized Anxiety Disorder 7-item (GAD-7) from baseline to 6, 12 months
timeFrame: From Baseline to 6 months, 12 months
measure: Changes in Sleep disturbance and impairment from baseline to 6, 12 months
timeFrame: From Baseline to 6 months, 12 months
measure: Changes in Sleep impairment from baseline to 6, 12 months
timeFrame: From Baseline to 6 months, 12 months
measure: Changes in functional impairment from baseline to 6, 12 months
timeFrame: From Baseline to 6 months, 12 months
measure: Changes in Cognitive functioning from baseline to 6, 12 months
timeFrame: From Baseline to 6 months, 12 months
measure: Changes in Obesity-related quality of life from baseline to 6, 12 months
timeFrame: From Baseline to 6 months, 12 months
measure: Changes in Generic health-related quality of life from baseline to 6, 12 months
timeFrame: From Baseline to 6 months, 12 months
measure: Changes in Social isolation from baseline to 6, 12 months
timeFrame: From Baseline to 6 months, 12 months
measure: Changes in loneliness from baseline to 6, 12 months
timeFrame: From Baseline to 6 months, 12 months
measure: Changes in physical activity from baseline to 6, 12 months
timeFrame: From Baseline to 6 months, 12 months
measure: Changes in sleep metrics from baseline to 6, 12 months
timeFrame: From Baseline to 6 months, 12 months
measure: Changes in diet intake from baseline to 6, 12 months
timeFrame: From Baseline to 6 months, 12 months
measure: Changes in problem-solving ability from baseline to 6, 12 months
timeFrame: From Baseline to 6 months, 12 months
measure: Changes in food insecurity from baseline to 12 months
timeFrame: From Baseline to 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Department of Medicine, Vitoux Program on Aging and Prevention
state: Illinois
city: Saint Louis
country: United States
facility: Washington University School of Medicine in St Louis
state: Missouri
Study officials:
References: