N/A
Completed N=409
Research Aimed at Improving Both Mood and Weight
Source: ClinicalTrials.gov NCT02246413 ↗Enrolled (actual)
409
Serious AEs
8.8%
Results posted
Jun 2020
Primary outcomePrimary: Co-Primary Outcome: Body Mass Index (BMI) — 35.9; 36.6 kg/m^2
Summary
The RAINBOW study is an NIH R01-funded randomized controlled trial to evaluate the clinical and cost effectiveness and implementation potential of a primary care integrated multicondition intervention program to help improve mood and weight for obese adults with clinically significant depressive symptoms. The ENGAGE study is a mechanistic investigation added to the main trial with funding through the NIH common fund for the Science of Behavior Change roadmap initiative. Beginning Jan 11, 2016, at least 100 of newly enrolled trial participants will be consented to undergo additional assays evaluating neurobiological mechanisms of self-regulation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Co-Primary Outcome: Body Mass Index (BMI) |
35.9; 36.6 | — |
| PRIMARY Co-Primary Outcome: Depression Symptom Checklist 20 (SCL-20) Score |
1.1; 1.4 | — |
| SECONDARY Body Mass Index |
36.2; 36.2 | — |
| SECONDARY Depression Symptom Checklist 20 (SCL-20) Score |
1.3; 1.4 | — |
| SECONDARY Weight |
101.8; 102.4 | — |
| SECONDARY Depression Remission (Number of Participants With SCL-20 Scores <0.5) |
30; 23 | — |
| SECONDARY Depression Remission (Number of Participants With SCL-20 Score <0.5) |
31; 20 | — |
| SECONDARY Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline) |
40; 39 | — |
| SECONDARY Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline) |
42; 37 | — |
| SECONDARY Cost-effectiveness |
1994; 1773 | — |
| SECONDARY Obesity-related Psychosocial Functioning (Obesity-related Problem Scale) |
51.1; 50.6 | — |
| SECONDARY Anxiety (GAD-7) |
4.8; 5.9 | — |
| SECONDARY Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) ) |
47.3; 45.4 | — |
| SECONDARY Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ) |
45.9; 43.9 | — |
| SECONDARY Disability (Sheehan Disability Scale) |
6; 6.9 | — |
| SECONDARY Utility-based Health-related Quality of Life (EQ-5D-Activity) |
1.5; 1.7 | — |
| SECONDARY Utility-based Health-related Quality of Life (EQ-5D-Pain) |
2; 2.3 | — |
| SECONDARY Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression) |
2; 2.2 | — |
| SECONDARY Utility-based Health-related Quality of Life (EQ-5D-Mobility) |
1.6; 1.6 | — |
| SECONDARY Utility-based Health-related Quality of Life (EQ-5D-Self-care) |
1.2; 1.2 | — |
| SECONDARY Sleep Disturbance T-score |
52.9; 55 | — |
| SECONDARY Sleep Impairment T-score |
52.2; 54.2 | — |
| SECONDARY Change in Activation of Left Amygdala From Baseline Functional Magnetic Resonance Scan at 2 Months (Regulation of Emotion) |
-0.32; 0.43 | — |
| SECONDARY Change in Activation of Right Amygdala From Baseline Functional Magnetic Resonance Scan at 2 Months (Regulation of Emotion) |
-0.07; 0.01 | — |
| SECONDARY Leisure Time Physical Activity |
704.5; 752.4 | — |
| SECONDARY Total Energy Expenditure |
33.1; 33.5 | — |
| SECONDARY Total Calorie Intake |
1592.4; 1591.3 | — |
| SECONDARY DASH (Dietary Approach to Stop Hypertension) Score |
2.4; 2.5 | — |
Eligibility Criteria
RAINBOW
Inclusion criteria
- Ethnicity and race: Any;
- Obesity: BMI≥30 kg/m2 for non-Asians; BMI≥27 kg/m2 for Asians;
- Clinically significant depressive symptoms: PHQ-9≥10;
- A PAMF patient for ≥1 year
- Seen in primary care at least once in the preceding 24 months;
- Able and willing to enroll and meet the requirements of the study
Exclusion criteria
- Inability to speak, read or understand English;
- Having no reliable telephone service, no device to use to watch a DVD, or no regular Internet access via a computer and/or mobile device;
- Had bariatric surgery within the past 12 months or plans to undergo bariatric surgery during the 24-month study period;
- Ongoing psychiatric care outside of the PAMF network.
- Active suicidal ideation that includes active plan and/or intent;
- Any Axis I disorder other than Minor or Major Depressive Disorder and/or Dysthymia, with the exception of any comorbid Anxiety Disorder;
- Active Bulimia Nervosa within the past 12 months (however Binge Eating Disorder without purging is not an exclusionary condition);
- Active alcohol or substance use disorder (including prescription drugs).
- Pre-existing diabetes (other than during pregnancy) or diabetes diagnosed as a result of fasting blood glucose or hemoglobin A1c levels obtained through study screening;
- Pre-existing cardiovascular disease.
- Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past 12 months;
- Severe medical comorbidities that require aggressive treatment, e.g., stage 4 or greater renal disease, liver failure;
- Diagnosis of a terminal illness and/or in hospice care;
- Residence in long-term care facility;
- Cognitive impairment based on the Callahan 6-item scale
- Plan to move out of the area or transfer care outside PAMF during the study period;
- Investigator discretion for reasons of clinical safety or protocol adherence.
ENGAGE
Inclusion criteria
- RAINBOW participant
Exclusion criteria
- Weight over 350 pounds
- MRI is contraindicated
- Traumatic brain injury
Data sourced from ClinicalTrials.gov (NCT02246413). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.