Digital InteGrated Behavioral TreatmeNt for Comorbid ObesITy and DeprEssion Among Racial and Ethnic Adults Age 50 and Older (IGNITE)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- University of Illinois at Chicago
- Enrollment
- 440
- Locations
- 2
- Primary Endpoint
- Changes in weight from baseline to 6 months
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Jun Ma
MD, PhD, Principal Investigator, Beth and George Vitoux Professor of Medicine Affiliation: University of Illinois at Chicago
University of Illinois at Chicago
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Changes in weight from baseline to 6 months
Time Frame: From Baseline to 6 months
All participants will receive a study-provided wireless weight scale (Withings Body - Digital Wi-Fi Smart Scale), assistance with account and device setup, and as-needed tech support. A study coordinator who is blinded to randomization will proactively contact participants by phone, email, and/or text to remind them to weigh themselves in the morning after urination (and a bowel movement too, if able to do so) on 3 days during the assessment week at baseline (0), 6, 12 months. Participants will be instructed to self-weigh in a T-shirt and undergarment and with no socks or shoes using their study-provided digital scale. We will obtain participants' self-monitored weight data using a developed program for automated daily synchronization via the Fitbit open API.
Changes in Depression Symptom Checklist 20-items (SCL-20) from baseline to 6 months
Time Frame: From Baseline to 6 months
The SCL-20 is a valid, reliable measure of depression severity. It has been used in numerous depression treatment trials in primary care and community settings, making it particularly useful for cross-study comparisons and data synthesis in meta-analyses. The SCL-20 had good internal consistency (Cronbach's alpha=0.859) and correlated well with the General Health Questionnaire (r=0.78), a psychiatric screening test.
Secondary Outcomes
- Changes in weight from baseline to 12 months(From Baseline to 12 months)
- Changes in Depression Symptom Checklist 20-items (SCL-20) from baseline to 12 months(From Baseline to 12 months)
- Clinically significant weight change from baseline(From baseline to 6 months, 12 months)
- Depression Response(From baseline to 6 months, 12 months)
- Depression Remission(Baseline, 6 months, 12 months)
- Changes in Generalized Anxiety Disorder 7-item (GAD-7) from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in Sleep disturbance and impairment from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in Sleep impairment from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in functional impairment from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in Cognitive functioning from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in Obesity-related quality of life from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in Generic health-related quality of life from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in Social isolation from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in loneliness from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in physical activity from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in sleep metrics from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in diet intake from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in problem-solving ability from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in food insecurity from baseline to 12 months(From Baseline to 12 months)