ObesityNCT03841682
Engaging Self-regulation Targets to Improve Mood and Weight and Understand Mechanism in Depressed and Obese Adults
A study testing I-CARE2 in people with Obesity and Depression, run by University of Illinois Chicago at 2 sites in United States.
Trial summary
Multimorbidity (i.e., the coexistence of 2 or more chronic conditions in an individual) is increasingly recognized as a pressing public health problem. Effective interventions targeting coexisting depression and obesity are critical given the high prevalence and worsened outcomes for patients with both conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Depression
- What is being tested?
- I-CARE2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2019to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: ≥18 years
- Body mass index based on study measurements at baseline group orientation: ≥30.0 kg/m2 (≥27.0 if Asian), and weight <350 pounds (due to fMRI scanner size limitations)
- Elevated depressive symptoms as per 9-item Patient Health Questionnaire (PHQ-9) scores ≥10 on study screening
- UI Health patient seen in primary care at least once in the preceding 18 months
- Able and willing to enroll and provide written informed consent
Who cannot join
- Active suicidal ideation based on PHQ-9 or the 20-item depression symptom checklist (SCL-20) that includes active plan and/or intent
- Any other psychiatric disorder other than persistent depressive disorder and/or major depressive disorder, with the exception of any comorbid anxiety disorder
- Active Bulimia Nervosa within the past 3 months (however Binge Eating Disorder without purging is not an exclusionary condition)
- Active alcohol or substance use disorder (including prescription drugs)
- Currently under the care of a psychiatrist or licensed mental health therapist outside of UI Health
- Had bariatric surgery (e.g., bypass, banding, sleeve, or biliopancreatic diversion with duodenal switch) within the past 12 months or plan to undergo bariatric surgery during the study period
Show all 21Show fewer
- Pre-existing diabetes (other than during pregnancy)
- Pre-existing cardiovascular disease: e.g., coronary heart disease (myocardial infarction, angina pectoris, percutaneous coronary intervention, and coronary artery bypass graft surgery), cerebrovascular disease (stroke, transient ischemic attack), peripheral vascular disease, heart failure, or aortic aneurysm.
- Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past year
- Severe medical comorbidities that require aggressive treatment, e.g., stage 4 or greater renal disease, and liver failure
- Diagnosis of a terminal illness and/or residence in a long-term care facility
- Cognitive impairment based on the Callahan 6-item screener
- MRI is contraindicated (weight over 350 pounds, traumatic brain injury, tumor or any other known structural abnormality in brain, bullet, shrapnel, or other projectile above the shoulder, not being able to lie down in an fMRI scanner for about an hour due to claustrophobia, personal history of epilepsy, convulsions, or seizures, have piercings that cannot be removed)
- Traumatic brain injury; Tumor or any other known structural abnormality in brain
- Inability to speak, read or understand English
- No reliable telephone service, or no regular Internet access via a computer and/or mobile device (e.g., smartphone)
- Plan to move out of the area or transfer care outside UI Health during the study period
- Currently pregnant, lactating, or planning to become pregnant during the study period
- Already enrolled, or planning to enroll, in another medical or behavioral intervention research study
- Family/household member of another participant or of a staff member
- Investigator discretion for clinical safety or protocol adherence reasons
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Institute for Health Research and Policy (IHRP), Center for Health Behavior Research
Chicago, Illinois, 60608
UIMC Advanced Imaging Center
Chicago, Illinois, 60612
About this study
Official title: Engaging Self-Regulation Targets to Understand the Mechanism of Behavior Change and Improve Mood and Weight Outcomes- Second Phase (ENGAGE-2)
Multimorbidity (i.e., the coexistence of 2 or more chronic conditions in an individual) is increasingly recognized as a pressing public health problem. Effective interventions targeting coexisting depression and obesity are critical given the high prevalence and worsened outcomes for patients with both conditions.
ENGAGE-2 is a pilot randomized controlled trial (RCT). The objective is to investigate the outcomes and mechanisms of an integrated depression and obesity intervention that combines collaborative stepped depression treatment and evidence-based behavioral weight loss treatment. The Integrated Coaching for Better Mood and Weight-2 (I-CARE2) intervention synergistically integrates 2 proven national programs: the Program to Encourage Active and Rewarding Lives (PEARLS) for depression care and the Group Lifestyle Balance (GLB) program for weight loss and cardiometabolic risk reduction.
In Phase 1 of the ENGAGE project, investigators developed a new protocol to quantify activation and connectivity of the Affective, Cognitive Control, and Default Mode brain circuits from functional magnetic resonance imaging (fMRI) among 108 depressed obese patients. Investigators implement the same fMRI protocol in this second phase of the project to examine the mechanistic role of these brain circuits as potential neural targets in treatment engagement and response in the I-CARE2 intervention. A new sample of 105 depressed obese patients are randomized in a 2:1 ratio to receive the I-CARE2 intervention (n=70) or usual care (n=35). Study assessments occur at 0 (baseline), 2 and 6 months. Investigators hypothesize that 1 or more of the neural targets under study will moderate (baseline state) and/or mediate (change at follow-up) the effect of the I-CARE2 intervention versus usual care on health behaviors (problem-solving ability, dietary intakes, physical activity) and clinical outcomes (weight loss, depression, anxiety).
Read the detailed description
Participants in this study are adult patients with comorbid depression and obesity from outpatient clinics in the University of Illinois Hospital and Health Sciences System (UI Health). Participants will be randomly assigned to receive intervention or usual care control.
The I-CARE2 intervention synergistically integrates the PEARLS program for depression care the GLB program for weight loss. The PEARLS program provides problem-solving therapy (PST) as first-line for treating depression, with as-needed antidepressant medication intensification. Adapted from the original Diabetes Prevention Program, the GLB program promotes healthy lifestyle change for weight loss and increased physical activity. For combination treatment, the I-CARE2 intervention provides 9 individual counseling sessions (4 weekly, 2 biweekly, and then 3 monthly; 1 hour each) and participant self-study materials (GLB videos, handouts, weight and activity tracking) over 6 months.
In response to the funding mechanism for this project, the specific aim of the ENGAGE-2 pilot study is to test the degree to which engaging the validated self-regulation target(s) produces desired behavior change important for weight management and mood.
- Conditions
- Obesity, Depression
- Being tested
- I-CARE2
- Medical subject headings
- Obesity, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-CARE2Behavioural
I-CARE2 intervention synergistically integrates 2 proven national programs: the Program to Encourage Active and Rewarding Lives (PEARLS) for depression care and the Group Lifestyle Balance (GLB) program for weight loss and cardiometabolic risk reduction.
The PEARLS program provides problem-solving therapy (PST) as first-line for treating depression, with as-needed antidepressant medication intensification. Adapted from the original Diabetes Prevention Program, the GLB program promotes healthy lifestyle change for weight loss and increased physical activity.
| Study group | Role | What they receive |
|---|---|---|
| I-CARE2 Intervention | Experimental | Participants should continue with their usual medical care. Additionally, participant receive the I-CARE2 intervention.
Trained health coaches deliver the I-CARE2 intervention over 6 months. The intervention provides 9 individual counseling sessions on problem solving treatment and behavior counselling to manage mood and lose weight (4 weekly, 2 biweekly, and then 3 monthly; 1 hour each), 11 home-viewed GLB videos (weekly; 20-30 minutes each), and self-study and self-monitoring activities. Throughout the intervention, participants are asked to wear and sync a study-provided Fitbit pedometer, and to log their weight, minutes of physical activity, and dietary intake using the Fitbit website or mobile app. Receives: Behavioral: I-CARE2 |
| Usual Care | No intervention | Participants should continue with their Usual Medical Care. Additionally, participants receive information on wellness and behavioral health promotion at UI Health and a Fitbit pedometer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression Symptom Checklist 20 items (SCL-20) at 6 months
The SCL-20 is a valid, reliable measure of depression severity, scores ranging from 0 (best) to 4 (worst). SCL-20 cutoff points of 1.5 and 2.0 correspond to moderate and severe depression, respectively. 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.
Measured: Baseline, 6 months
Change in Boby Mass Index (BMI) at 6 months
BMI will be calculated based on height and weight measured per standard protocols
Measured: Baseline, 6 months
Secondary outcomes (26)
Anxiety
Anxiety is measured using Panic Disorder module of the Mini-International Neuropsychiatric Interview (MINI).
Measured: Baseline, 6 months
Self-regulation of emotion, cognition, and self-reflection
fMRI scan will be used to evaluate self-regulation of emotion, cognition, and self-reflection
Measured: Baseline, 2 months, 6 months
Change in Depression Symptom Checklist 20 items (SCL-20) at 2 months
The SCL-20 is a valid, reliable measure of depression severity, scores ranging from 0 (best) to 4 (worst). SCL-20 cutoff points of 1.5 and 2.0 correspond to moderate and severe depression, respectively. 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.
Measured: Baseline, 2 months
Change in Body Mass Index (BMI) at 2 months
BMI will be calculated based on height and weight measured per standard protocols
Measured: Baseline, 2 months
Anxiety
Anxiety is measured using Generalized Anxiety Disorder Scale (GAD-7).
Measured: Baseline, 2 months, 6 months
Dietary Intake
Dietary intake will be recorded using 24-hours dietary recalls
Measured: Baseline, 2 months, 6 months
Fruit, vegetable, fat and fiber intake
17-item fruit, vegetable, fat, and fiber screener will be used.
Measured: Baseline, 2 months, 6 months
Physical activity (PA)
PA will be measured using 7-day Physical Activity Recall
Measured: Baseline, 2 months, 6 months
Steps
Steps will be calculated using Fitbit
Measured: Baseline, 2 months, 6 months
Problem solving
Problem Solving will be evaluated using Social Problem-Solving Inventory-Revised: Short Form
Measured: Baseline, 2 months, 6 months
Depression Response
This will be evaluated using depression symptom checklist SCL-20 (50% decline in SCL-20 scores from baseline)
Measured: 2 months, 6 months
Complete Depression Remission
Evaluated using depression symptom checklist SCL-20 (SCL-20 <0.5)
Measured: 2 months, 6 months
Weight (kg)
Measured using a weight scale. Missing study-measured weight may be replaced with weight from electronic health records or self-reported weight.
Measured: Baseline, 2 months, 6 months
Clinically significant weight change from baseline
Dichotomous variable based on if participants reaching 5% weight loss from baseline.
Measured: 2 months, 6 months
Blood pressure
The American Heart Association recommendations for BP measurement will be followed. BP will be measured in the seated position after at least a 5-minute rest in a separate, quiet room where no other activity is taking place and where temperature fluctuations are minimal. At baseline, both arms will be measured once and 2 more times on the arm with higher systolic reading using standard equipment. This same arm will be measured 3 times at each follow-up assessment. Wait 1 minute between each measurement.
Measured: Baseline, 2 months, 6 months
Waist circumference
Waist circumference will be measured using a study-provided body tape measure placed on bare skin in a horizontal plane around the abdomen at the uppermost lateral border of the right iliac crest. Waist circumference will be measured to the nearest 0.1 centimeters. Two measurements will be taken, and if the measurements differ by 1.0 cm or more, then take a third.
Measured: Baseline, 2 months, 6 months
Sleep and wake function
Sleep quality will be assessed on the 8-item Patient-Reported Outcomes Measurement Information System (PROMIS™) sleep disturbance (SD) and sleep-related impairment (SRI) scales short forms. The former measures symptoms of insomnia and the latter measures symptoms of daytime sleepiness. Each item is scaled from 1 (not at all) to 5 (very much). Correlation between the SD short form and the Pittsburgh Sleep Quality Index (PSQI, hypothesized to measure similar attributes) is 0.83 and correlation between the SRI short form and the Epworth Sleepiness Scale (ESS, hypothesized to measure a related but slightly different construct, the propensity to doze during activities) is 0.46, similar to the correlations between the SD full banks and PSQI (0.85) and between SRI full banks and the ESS (0.45).
Measured: Baseline, 2 months, 6 months
Perceived stress
Perceived stress is measured using Perceived stress scale (PSS). PSS measures the perception of stress (i.e., the degree to which situations in one's life are appraised as stressful). PSS contains 14 items, rated on a 5-point scale ranging from "never" to "very often." After reversing the scores on 7 positive items, a sum of score is calculated with higher score indicating higher perceived stress. Cronbach's alpha ranged from 0.84 to 0.86.
Measured: Baseline, 6 months
Disability
Disability is measured using Sheehan Disability Scale. The Sheehan Disability Scale is a validated questionnaire that measures functional disability and is sensitive to treatment effects in clinical trials. Patients rate the extent to which their symptoms impair work/school, social, and family life on a visual analog scale from0 to 10 and answer the number of days when their symptoms cause them to miss work/school and be unproductive at work/school.
Measured: Baseline, 6 months
Generic health related quality of life
Generic health related quality of life is measured using SF-8 Health Survey. The SF-8 is an 8-item version of the SF-36 that measures overall health-related quality of life. Physical and mental health composite scores are computed using the scores of 8 questions and range from 0 to 100, with 0 indicating the lowest level of health and 100 indicating the highest level of health. Correlation between the SF-8 and the SF-36 is 0.825 for physical health component and 0.881 for mental health component.
Measured: Baseline, 6 months
Obesity-specific health related questions
The Obesity-Related Problem Scale specifically measures the impact of obesity on psychosocial functioning. The 8-item scale has high internal reliability and sound test-retest reliability, correlates strongly with a wide range of theoretically related constructs, and is responsive to weight loss intervention.
Measured: Baseline, 6 months
Posttraumatic stress disorder
Posttraumatic stress disorder is measured using the 17-item PTSD checklist - Civilian Version (PCL-C) that has high reliability and validity.
Measured: Baseline, 6 months
Pain interference and intensity
Pain is measured using PROMIS SF - Pain Interference 4a and Numeric Rating Scale - Pain Intensity 1a.
Measured: Baseline, 6 months
Binge eating severity
Binge eating severity is measured using the Binge eating severity scale.
Measured: Baseline, 6 months
Use of general wellness programs and services questionnaire
This questionnaire asks participants if they have received a list of wellness programs and services for general physical and mental well-being in the past 6 months.
Measured: 6 months
Self-regulation of emotion, cognition, & self-reflection
BiAffect (Smart phone passive data collection) will be used, as an alternative, to evaluate self-regulation of emotion, cognition, and self-reflection
Measured: Baseline, 2 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Mar 2019
- Primary completion31 Aug 2020
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, University of Washington, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jun Ma, University of Illinois Chicago
- Investigators
- Jun Ma, MD,PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841682
- Sponsor's protocol ID
- 2018-1174
- Other IDs
- UH3HL132368
- Status last verified
- Oct 2021
- First submitted
- 2 Feb 2019
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lv N, Hallihan H, Xiao L, Williams LM, Ajilore OA, Ma J. Association of Changes in Neural Targets and Dietary Outcomes among Patients with Comorbid Obesity and Depression: Post hoc Analysis of ENGAGE-2 Mechanistic Clinical Trial. J Nutr. 2023 Mar;153(3):880-896. doi: 10.1016/j.tjnut.2023.01.022. Epub 2023 Jan 23.
PubMed 36931755Burton TC, Lv N, Tsai P, Penalver Bernabe B, Tussing-Humphreys L, Xiao L, Pandey GN, Wu Y, Ajilore OA, Ma J. Associations between fecal short-chain fatty acids, plasma inflammatory cytokines, and dietary markers with depression and anxiety: Post hoc analysis of the ENGAGE-2 pilot trial. Am J Clin Nutr. 2023 Apr;117(4):717-730. doi: 10.1016/j.ajcnut.2023.01.018. Epub 2023 Feb 1.
PubMed 36796440Kannampallil T, Dai R, Lv N, Xiao L, Lu C, Ajilore OA, Snowden MB, Venditti EM, Williams LM, Kringle EA, Ma J. Cross-trial prediction of depression remission using problem-solving therapy: A machine learning approach. J Affect Disord. 2022 Jul 1;308:89-97. doi: 10.1016/j.jad.2022.04.015. Epub 2022 Apr 7.
PubMed 35398399Lv N, Ajilore OA, Ronneberg CR, Venditti EM, Snowden MB, Lavori PW, Xiao L, Goldstein-Piekarski AN, Wielgosz J, Wittels NE, Barve A, Patel AS, Eckley TL, Stetz P, Gerber BS, Smyth JM, Simmons JM, Rosas LG, Williams LM, Ma J. The ENGAGE-2 study: Engaging self-regulation targets to understand the mechanisms of behavior change and improve mood and weight outcomes in a randomized controlled trial (Phase 2). Contemp Clin Trials. 2020 Aug;95:106072. doi: 10.1016/j.cct.2020.106072. Epub 2020 Jul 2.
PubMed 32621905
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Self-Regulation Targets to Understand the Mechanism of Behavior Change and Improve Mood and Weight Outcomes- Second Phase (ENGAGE-2)
- ClinicalTrials.gov ID
- NCT03841682
- Acronym / sponsor ID
- 2018-1174
- Conditions
- Obesity, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Stanford University, University of Washington, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multimorbidity (i.e., the coexistence of 2 or more chronic conditions in an individual) is increasingly recognized as a pressing public health problem. Effective interventions targeting coexisting depression and obesity are critical given the high prevalence and worsened outcomes for patients with both conditions.
ENGAGE-2 is a pilot randomized controlled trial (RCT). The objective is to investigate the outcomes and mechanisms of an integrated depression and obesity intervention that combines collaborative stepped depression treatment and evidence-based behavioral weight loss treatment. The Integrated Coaching for Better Mood and Weight-2 (I-CARE2) intervention synergistically integrates 2 proven national programs: the Program to Encourage Active and Rewarding Lives (PEARLS) for depression care and the Group Lifestyle Balance (GLB) program for weight loss and cardiometabolic risk reduction.
In Phase 1 of the ENGAGE project, investigators developed a new protocol to quantify activation and connectivity of the Affective, Cognitive Control, and Default Mode brain circuits from functional magnetic resonance imaging (fMRI) among 108 depressed obese patients. Investigators implement the same fMRI protocol in this second phase of the project to examine the mechanistic role of these brain circuits as potential neural targets in treatment engagement and response in the I-CARE2 intervention. A new sample of 105 depressed obese patients are randomized in a 2:1 ratio to receive the I-CARE2 intervention (n=70) or usual care (n=35). Study assessments occur at 0 (baseline), 2 and 6 months. Investigators hypothesize that 1 or more of the neural targets under study will moderate (baseline state) and/or mediate (change at follow-up) the effect of the I-CARE2 intervention versus usual care on health behaviors (problem-solving ability, dietary intakes, physical activity) and clinical outcomes (weight loss, depression, anxiety).
Detailed description
Participants in this study are adult patients with comorbid depression and obesity from outpatient clinics in the University of Illinois Hospital and Health Sciences System (UI Health). Participants will be randomly assigned to receive intervention or usual care control.
The I-CARE2 intervention synergistically integrates the PEARLS program for depression care the GLB program for weight loss. The PEARLS program provides problem-solving therapy (PST) as first-line for treating depression, with as-needed antidepressant medication intensification. Adapted from the original Diabetes Prevention Program, the GLB program promotes healthy lifestyle change for weight loss and increased physical activity. For combination treatment, the I-CARE2 intervention provides 9 individual counseling sessions (4 weekly, 2 biweekly, and then 3 monthly; 1 hour each) and participant self-study materials (GLB videos, handouts, weight and activity tracking) over 6 months.
In response to the funding mechanism for this project, the specific aim of the ENGAGE-2 pilot study is to test the degree to which engaging the validated self-regulation target(s) produces desired behavior change important for weight management and mood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-CARE2 Intervention | Experimental | Behavioral: I-CARE2Participants should continue with their usual medical care. Additionally, participant receive the I-CARE2 intervention. Trained health coaches deliver the I-CARE2 intervention over 6 months. The intervention provides 9 individual counseling sessions on problem solving treatment and behavior counselling to manage mood and lose weight (4 weekly, 2 biweekly, and then 3 monthly; 1 hour each), 11 home-viewed GLB videos (weekly; 20-30 minutes each), and self-study and self-monitoring activities. Throughout the intervention, participants are asked to wear and sync a study-provided Fitbit pedometer, and to log their weight, minutes of physical activity, and dietary intake using the Fitbit website or mobile app. |
| Usual Care | No intervention | –Participants should continue with their Usual Medical Care. Additionally, participants receive information on wellness and behavioral health promotion at UI Health and a Fitbit pedometer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: ≥18 years
- Body mass index based on study measurements at baseline group orientation: ≥30.0 kg/m2 (≥27.0 if Asian), and weight <350 pounds (due to fMRI scanner size limitations)
- Elevated depressive symptoms as per 9-item Patient Health Questionnaire (PHQ-9) scores ≥10 on study screening
- UI Health patient seen in primary care at least once in the preceding 18 months
- Able and willing to enroll and provide written informed consent
Key exclusion criteria (21 listed)
- Active suicidal ideation based on PHQ-9 or the 20-item depression symptom checklist (SCL-20) that includes active plan and/or intent
- Any other psychiatric disorder other than persistent depressive disorder and/or major depressive disorder, with the exception of any comorbid anxiety disorder
- Active Bulimia Nervosa within the past 3 months (however Binge Eating Disorder without purging is not an exclusionary condition)
- Active alcohol or substance use disorder (including prescription drugs)
- Currently under the care of a psychiatrist or licensed mental health therapist outside of UI Health
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-CARE2I-CARE2 intervention synergistically integrates 2 proven national programs: the Program to Encourage Active and Rewarding Lives (PEARLS) for depression care and the Group Lifestyle Balance (GLB) program for weight loss and cardiometabolic risk reduction. The PEARLS program provides problem-solving therapy (PST) as first-line for treating depression, with as-needed antidepressant medication intensification. Adapted from the original Diabetes Prevention Program, the GLB program promotes healthy lifestyle change for weight loss and increased physical activity. | Behavioural | I-CARE2 Intervention |
Primary outcome
Change in Depression Symptom Checklist 20 items (SCL-20) at 6 months
Time frame: Baseline, 6 months
The SCL-20 is a valid, reliable measure of depression severity, scores ranging from 0 (best) to 4 (worst). SCL-20 cutoff points of 1.5 and 2.0 correspond to moderate and severe depression, respectively. 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.
Change in Boby Mass Index (BMI) at 6 months
Time frame: Baseline, 6 months
BMI will be calculated based on height and weight measured per standard protocols
26 secondary outcomes
Anxiety
Time frame: Baseline, 6 months
Self-regulation of emotion, cognition, and self-reflection
Time frame: Baseline, 2 months, 6 months
Change in Depression Symptom Checklist 20 items (SCL-20) at 2 months
Time frame: Baseline, 2 months
Change in Body Mass Index (BMI) at 2 months
Time frame: Baseline, 2 months
Anxiety
Time frame: Baseline, 2 months, 6 months
Dietary Intake
Time frame: Baseline, 2 months, 6 months
Fruit, vegetable, fat and fiber intake
Time frame: Baseline, 2 months, 6 months
Physical activity (PA)
Time frame: Baseline, 2 months, 6 months
Steps
Time frame: Baseline, 2 months, 6 months
Problem solving
Time frame: Baseline, 2 months, 6 months
Depression Response
Time frame: 2 months, 6 months
Complete Depression Remission
Time frame: 2 months, 6 months
Weight (kg)
Time frame: Baseline, 2 months, 6 months
Clinically significant weight change from baseline
Time frame: 2 months, 6 months
Blood pressure
Time frame: Baseline, 2 months, 6 months
Waist circumference
Time frame: Baseline, 2 months, 6 months
Sleep and wake function
Time frame: Baseline, 2 months, 6 months
Perceived stress
Time frame: Baseline, 6 months
Disability
Time frame: Baseline, 6 months
Generic health related quality of life
Time frame: Baseline, 6 months
Obesity-specific health related questions
Time frame: Baseline, 6 months
Posttraumatic stress disorder
Time frame: Baseline, 6 months
Pain interference and intensity
Time frame: Baseline, 6 months
Binge eating severity
Time frame: Baseline, 6 months
Use of general wellness programs and services questionnaire
Time frame: 6 months
Self-regulation of emotion, cognition, & self-reflection
Time frame: Baseline, 2 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Derived from this study: PubMed 36931755Lv N, Hallihan H, Xiao L, Williams LM, Ajilore OA, Ma J. Association of Changes in Neural Targets and Dietary Outcomes among Patients with Comorbid Obesity and Depression: Post hoc Analysis of ENGAGE-2 Mechanistic Clinical Trial. J Nutr. 2023 Mar;153(3):880-896. doi: 10.1016/j.tjnut.2023.01.022. Epub 2023 Jan 23.
- Derived from this study: PubMed 36796440Burton TC, Lv N, Tsai P, Penalver Bernabe B, Tussing-Humphreys L, Xiao L, Pandey GN, Wu Y, Ajilore OA, Ma J. Associations between fecal short-chain fatty acids, plasma inflammatory cytokines, and dietary markers with depression and anxiety: Post hoc analysis of the ENGAGE-2 pilot trial. Am J Clin Nutr. 2023 Apr;117(4):717-730. doi: 10.1016/j.ajcnut.2023.01.018. Epub 2023 Feb 1.
- Derived from this study: PubMed 35398399Kannampallil T, Dai R, Lv N, Xiao L, Lu C, Ajilore OA, Snowden MB, Venditti EM, Williams LM, Kringle EA, Ma J. Cross-trial prediction of depression remission using problem-solving therapy: A machine learning approach. J Affect Disord. 2022 Jul 1;308:89-97. doi: 10.1016/j.jad.2022.04.015. Epub 2022 Apr 7.
- Derived from this study: PubMed 32621905Lv N, Ajilore OA, Ronneberg CR, Venditti EM, Snowden MB, Lavori PW, Xiao L, Goldstein-Piekarski AN, Wielgosz J, Wittels NE, Barve A, Patel AS, Eckley TL, Stetz P, Gerber BS, Smyth JM, Simmons JM, Rosas LG, Williams LM, Ma J. The ENGAGE-2 study: Engaging self-regulation targets to understand the mechanisms of behavior change and improve mood and weight outcomes in a randomized controlled trial (Phase 2). Contemp Clin Trials. 2020 Aug;95:106072. doi: 10.1016/j.cct.2020.106072. Epub 2020 Jul 2.
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Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Ma, MD,PhD principal investigator
University of Illinois Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-CARE2 in people with Obesity and Depression, run by University of Illinois Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depression Symptom Checklist 20 items (SCL-20) at 6 months (time frame: Baseline, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03841682, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.