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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL119453 | U.S. NIH Grant/Contract | View source | |
| UH2HL132368 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| University of Washington | OTHER |
| University of Pittsburgh | OTHER |
| Stanford University |
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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.
The large numbers of primary care patients affected by coexisting obesity and depression and common risk factors for diabetes and heart disease underscore the urgency of developing effective, accessible, and sustainable interventions that use an integrated, multicondition care management approach. The RAINBOW trial will rigorously evaluate the clinical and cost effectiveness and potential for "real-world" implementation of an innovative intervention that integrates a behavioral weight loss program and a collaborative stepped care program for depression, incorporates conventional clinic- and home-based modes of care delivery (e.g., office visits plus phone consults and take-home DVD), and leverages low-cost, wide-reach health information technologies (e.g., Web, secure email, and mobile texting). Beginning Jan 11, 2016, at least 100 of newly enrolled trial participants will also be consented to undergo additional assays evaluating neurobiological mechanisms of self-regulation, including emotional regulation, cognitive control and self-reflection. Given its focus on transforming primary care management of obesity and depression and common cardiometabolic risk factors to evidence-based, patient-centered care, as well as the likely scalability of the proposed intervention, the study has high potential for significant clinical and public health impact. Furthermore, elucidating the neurobiological mechanisms of self-regulation will significantly advance precision lifestyle medicine by enabling mechanism-targeted individualization of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAINBOW Intervention Program | Experimental | An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease. |
|
| Usual Care | No Intervention | Usual Care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAINBOW Intervention Program | Behavioral | Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care |
| Measure | Description | Time Frame |
|---|---|---|
| Co-Primary Outcome: Body Mass Index (BMI) | Integrated intervention treatment response | 12 months |
| Co-Primary Outcome: Depression Symptom Checklist 20 (SCL-20) Score | Depression Symptom Checklist 20 (SCL-20) questionnaire score. SCL-20, average scores of the 20 items with a range from 0 (not at all) to 4 (extremely). SCL-20 cutoff points scores of ≤0.75, >0.75-1.5, >1.5- 2.0, and >2.0 represent remission, mild depression, moderate depression, and severe depression, respectively. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | Derived from height and weight measurements | 24 months |
| Depression Symptom Checklist 20 (SCL-20) Score | SCL-20 full questionnaire. SCL-20, average scores of the 20 items with a range from 0 (not at all) to 4 (extremely). SCL-20 cutoff points scores of ≤0.75, >0.75-1.5, >1.5- 2.0, and >2.0 represent remission, mild depression, moderate depression, and severe depression, respectively. |
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RAINBOW
Inclusion criteria:
Exclusion criteria:
ENGAGE
Inclusion criteria:
• RAINBOW participant
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Ma, MD, PhD | University of Illinois at Chicago | Principal Investigator |
| Leanne Williams, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palo Alto Medical Foundation | Palo Alto | California | 94301 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39615398 | Derived | Lv N, Chin SW, Xiao L, Tang Z, Parikh A, Ma J. Sex moderates diet quality differences in integrated collaborative care for comorbid obesity and depression: Post-hoc analysis of the RAINBOW RCT. J Nutr Health Aging. 2025 Jan;29(1):100426. doi: 10.1016/j.jnha.2024.100426. Epub 2024 Nov 29. | |
| 39231241 | Derived | Zhang X, Pines A, Stetz P, Goldstein-Piekarski AN, Xiao L, Lv N, Tozzi L, Lavori PW, Snowden MB, Venditti EM, Smyth JM, Suppes T, Ajilore O, Ma J, Williams LM. Adaptive cognitive control circuit changes associated with problem-solving ability and depression symptom outcomes over 24 months. Sci Transl Med. 2024 Sep 4;16(763):eadh3172. doi: 10.1126/scitranslmed.adh3172. Epub 2024 Sep 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | RAINBOW Intervention Program | An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease. RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care |
| FG001 | Usual Care | Usual Care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 12-months (Primary Outcome) |
| |||||||||||||
| 24-months (Secondary Outcome) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RAINBOW Intervention Program | An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease. RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Co-Primary Outcome: Body Mass Index (BMI) | Integrated intervention treatment response | In the case of missing study-measured weight, the closest EHR weight within 3 months of the due date of a missed study visit or self-reported weight (if no EHR weight) was used. So the number of participants analyzed is not consistent with the number in the Participant Flow module. | Posted | Mean | Standard Deviation | kg/m^2 | 12 months |
|
Primary and secondary outcome period (up to 24-months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RAINBOW Intervention Program | An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease. RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Digestive system problem | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphatic problems | Blood and lymphatic system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nan Lv, PhD, Research Scientist | Univeristy of Illinois, Chicago | 312-802-1072 | lvn2017@uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2016 | May 8, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D009765 | Obesity |
| D000068356 | Self-Control |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D050177 | Overweight |
| D044343 | Overnutrition |
Not provided
Not provided
| OTHER |
| University of Illinois at Chicago | OTHER |
| Sutter Health | OTHER |
Not provided
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| 24 months |
| Weight | Weight measurements | 12 months |
| Weight | Weight measurements | 24 months |
| Depression Remission (Number of Participants With SCL-20 Scores <0.5) | Depression remission defined by Depression Symptom Checklist 20 (SCL-20) scores <0.5 | 12 months |
| Depression Remission (Number of Participants With SCL-20 Score <0.5) | Depression remission defined by Depression Symptom Checklist 20 (SCL-20) scores <0.5 | 24 months |
| Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline) | Depression treatment response defined by 50% decline in SCL-20 symptom scores | 12 months |
| Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline) | Depression treatment response defined by 50% decline in SCL-20 symptom scores | 24 months |
| Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline) | 5% or greater weight loss from baseline | 12 months |
| Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline) | 5% or greater weight loss from baseline | 24 months |
| Cost-effectiveness | Average annual per person spending on medical care services (2018 real US dollars) | 12 months |
| Obesity-related Psychosocial Functioning (Obesity-related Problem Scale) | Obesity-related Problem Scale, average scores of 8 questions with a range from 0 (no at all) to 3 (extremely). The average score is then multiplied by 100 and divided by 3 to convert to a scale of 0-100, with a higher score indicating more obesity-related problems. | 12 months |
| Anxiety (GAD-7) | Self-administered questionnaire. Total scores of the 7 items with a range from 0 (no symptoms) to 21 (most severe symptoms). | 12 months |
| Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) ) | Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - physical component (PCS) ) Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life. | 12 months |
| Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ) | Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ). Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life. | 12 months |
| Disability (Sheehan Disability Scale) | Self-administered Sheehan Disability Scale questionnaire. Sheehan Disability Scale, total scores of the 3 items with a range from 0 (unimpaired) to 30 (highly impaired). Scores of ≥5 on any of the 3 scales (Work/school [0-10], Social life [0-10], and Family life/home responsibilities [0-10]) are associated with significant functional impairment. | 12 months |
| Utility-based Health-related Quality of Life (EQ-5D-Activity) | Self-administered questionnaire: Utility-based Health-related Quality of Life - USUAL ACTIVITIES (e.g. work, study, housework, family or leisure activities). A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems. | 12 months |
| Utility-based Health-related Quality of Life (EQ-5D-Pain) | Self-administered questionnaire: Utility-based Health-related Quality of Life - PAIN/DISCOMFORT. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems. | 12 months |
| Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression) | Self-administered questionnaire: Utility-based Health-related Quality of Life - Anxiety and depression. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems. | 12 months |
| Utility-based Health-related Quality of Life (EQ-5D-Mobility) | Self-administered questionnaire: Utility-based Health-related Quality of Life - Mobility. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems. | 12 months |
| Utility-based Health-related Quality of Life (EQ-5D-Self-care) | Self-administered questionnaire: Utility-based Health-related Quality of Life - Self-care. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems. | 12 months |
| Sleep Disturbance T-score | Sleep disturbance T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness. | 12 months |
| Sleep Impairment T-score | Sleep Impairment T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness. | 12 months |
| Change in Activation of Left Amygdala From Baseline Functional Magnetic Resonance Scan at 2 Months (Regulation of Emotion) | Regulation of emotion, specially activation of the amygdala for nonconscious threat-related emotional reactivity, is assessed using fMRI. In the facial emotion viewing paradigm, facial expression stimuli are standardized black and white photographs of 8 identities (4 female, 4 male) with evoked expressions of threat-related emotions (fear, anger), sad-related emotions (sadness) and reward-related emotions (happiness), along with neutral. To assess amygdala activation for the negative affect circuit, our analysis focused on threatening faces only. Threat stimuli included a combination of fear and anger stimuli relative to neutral blocks. A hemodynamic response convolved boxcar function was used to model the BOLD response for each block of emotional expressions to threat and to sadness relative to neutral face blocks. General linear models were then specified for each task to investigate the contrasts of interest. Higher beta-weight indicates higher activation of the amygdala. | Baseline, 2 months |
| Change in Activation of Right Amygdala From Baseline Functional Magnetic Resonance Scan at 2 Months (Regulation of Emotion) | Regulation of emotion, specially activation of the amygdala for nonconscious threat-related emotional reactivity, is assessed using fMRI. In the facial emotion viewing paradigm, facial expression stimuli are standardized black and white photographs of 8 identities (4 female, 4 male) with evoked expressions of threat-related emotions (fear, anger), sad-related emotions (sadness) and reward-related emotions (happiness), along with neutral. To assess amygdala activation for the negative affect circuit, our analysis focused on threatening faces only. Threat stimuli included a combination of fear and anger stimuli relative to neutral blocks. A hemodynamic response convolved boxcar function was used to model the BOLD response for each block of emotional expressions to threat and to sadness relative to neutral face blocks. General linear models were then specified for each task to investigate the contrasts of interest. Higher beta-weight indicates higher activation of the amygdala. | Baseline, 2 months |
| Obesity-related Psychosocial Functioning (Obesity-related Problem Scale) | Obesity-related Problem Scale, average scores of 8 questions with a range from 0 (no at all) to 3 (extremely). The average score is then multiplied by 100 and divided by 3 to convert to a scale of 0-100, with a higher score indicating more obesity-related problems. | 24 months |
| Anxiety (GAD-7) | Self-administered questionnaire. Total scores of the 7 items with a range from 0 (no symptoms) to 21 (most severe symptoms). | 24 months |
| Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) ) | Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - physical component (PCS) ). Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life. | 24 months |
| Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ) | Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ). Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life. | 24 months |
| Disability (Sheehan Disability Scale) | Self-administered Sheehan Disability Scale questionnaire. Sheehan Disability Scale, total scores of the 3 items with a range from 0 (unimpaired) to 30 (highly impaired). Scores of ≥5 on any of the 3 scales (Work/school [0-10], Social life [0-10], and Family life/home responsibilities [0-10]) are associated with significant functional impairment. | 24 months |
| Utility-based Health-related Quality of Life (EQ-5D-Activity) | Self-administered questionnaire: Utility-based Health-related Quality of Life - USUAL ACTIVITIES (e.g. work, study, housework, family or leisure activities). A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems. | 24 months |
| Utility-based Health-related Quality of Life (EQ-5D-Pain) | Self-administered questionnaire: Utility-based Health-related Quality of Life - PAIN/DISCOMFORT. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems. | 24 months |
| Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression) | Self-administered questionnaire: Utility-based Health-related Quality of Life - Anxiety and depression. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems. | 24 months |
| Utility-based Health-related Quality of Life (EQ-5D-Mobility) | Self-administered questionnaire: Utility-based Health-related Quality of Life - Mobility. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems. | 24 months |
| Utility-based Health-related Quality of Life (EQ-5D-Self-care) | Self-administered questionnaire: Utility-based Health-related Quality of Life - Self-care. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems. | 24 months |
| Sleep Disturbance T-score | Sleep disturbance T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness. | 24 months |
| Sleep Impairment T-score | Sleep Impairment T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness. | 24 months |
| Leisure Time Physical Activity | Physical activity was assessed as metabolic equivalent task (MET) minutes per week of leisure-time physical activity of at least moderate intensity based on the sum of the weighted physical activity minutes for moderate (weight: 4 METs), hard (weight: 6 METs), and very hard (weight: 10 METs) activities from the 7-day Physical Activity Recall. | 7-day Physical Activity Recall was administered at 12 months |
| Total Energy Expenditure | Totally energy expenditure was measured using the 7-day Physical Activity Recall and provides estimates of total daily energy expenditures (total energy expenditure = sleep hours × 1 MET + light activity hours × 1.5 METs + moderate activity hours × 4 METs + hard activity hours × 6 METs + very hard activity hours × 10 METs). | 7-day Physical Activity Recall was administered at 12 months |
| Total Calorie Intake | Total calorie intake was measured using 24-hour dietary recalls and provides total energy intake. | One day's 24-hour dietary recall was administered at 12 months |
| DASH (Dietary Approach to Stop Hypertension) Score | Using 24-hour diet recalls, DASH scores were calculated based on combining nine nutrient targets (i.e. total fat, saturated fat, protein, cholesterol, fiber, magnesium, calcium, sodium and potassium). The intermediate target of each nutrient was half-way between the DASH target and population mean (based on the National Health and Nutrition Examination Surveys 2007-2008, latest data available at the inception of the study). For a nutrient, participants reaching the DASH target were assigned one point, those reaching the intermediate target were assigned a half-point, and those not meeting the intermediate target were given 0 points. The DASH score was the sum of points for all nine nutrients and ranged from 0 to 9. DASH score is a measure of diet quality, with higher score indicating higher diet quality | One day's 24-hour dietary recall was administered at 12 months |
| Stanford |
| California |
| 94305 |
| United States |
| 35398399 | Derived | Kannampallil 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. |
| 34476464 | Derived | Lv N, Lefferts WK, Xiao L, Goldstein-Piekarski AN, Wielgosz J, Lavori PW, Simmons JM, Smyth JM, Stetz P, Venditti EM, Lewis MA, Rosas LG, Snowden MB, Ajilore OA, Suppes T, Williams LM, Ma J. Problem-solving therapy-induced amygdala engagement mediates lifestyle behavior change in obesity with comorbid depression: a randomized proof-of-mechanism trial. Am J Clin Nutr. 2021 Dec 1;114(6):2060-2073. doi: 10.1093/ajcn/nqab280. |
| 34004422 | Derived | Goldstein-Piekarski AN, Wielgosz J, Xiao L, Stetz P, Correa CG, Chang SE, Lv N, Rosas LG, Lavori PW, Snowden MB, Venditti EM, Simmons JM, Smyth JM, Suppes T, Lewis MA, Ajilore O, Ma J, Williams LM. Early changes in neural circuit function engaged by negative emotion and modified by behavioural intervention are associated with depression and problem-solving outcomes: A report from the ENGAGE randomized controlled trial. EBioMedicine. 2021 May;67:103387. doi: 10.1016/j.ebiom.2021.103387. Epub 2021 May 17. |
| 33616188 | Derived | Lv N, Xiao L, Rosas LG, Venditti EM, Smyth JM, Lewis MA, Snowden MB, Ronneberg CR, Williams LM, Gerber BS, Ajilore OA, Patel AS, Ma J. Sex Moderates Treatment Effects of Integrated Collaborative Care for Comorbid Obesity and Depression: The RAINBOW RCT. Ann Behav Med. 2021 Nov 18;55(12):1157-1167. doi: 10.1093/abm/kaaa125. |
| 32320533 | Derived | Goldhaber-Fiebert JD, Prince L, Xiao L, Lv N, Rosas LG, Venditti EM, Lewis MA, Snowden MB, Ma J. First-Year Economic and Quality of Life Effects of the RAINBOW Intervention to Treat Comorbid Obesity and Depression. Obesity (Silver Spring). 2020 Jun;28(6):1031-1039. doi: 10.1002/oby.22805. Epub 2020 Apr 22. |
| 32315362 | Derived | Lv N, Xiao L, Majd M, Lavori PW, Smyth JM, Rosas LG, Venditti EM, Snowden MB, Lewis MA, Ward E, Lesser L, Williams LM, Azar KMJ, Ma J. Variability in engagement and progress in efficacious integrated collaborative care for primary care patients with obesity and depression: Within-treatment analysis in the RAINBOW trial. PLoS One. 2020 Apr 21;15(4):e0231743. doi: 10.1371/journal.pone.0231743. eCollection 2020. |
| 32067873 | Derived | Rosas LG, Azar KMJ, Lv N, Xiao L, Goldhaber-Fiebert JD, Snowden MB, Venditti EM, Lewis MM, Goldstein-Piekarski AN, Ma J. Effect of an Intervention for Obesity and Depression on Patient-Centered Outcomes: An RCT. Am J Prev Med. 2020 Apr;58(4):496-505. doi: 10.1016/j.amepre.2019.11.005. Epub 2020 Feb 14. |
| 30835308 | Derived | Ma J, Rosas LG, Lv N, Xiao L, Snowden MB, Venditti EM, Lewis MA, Goldhaber-Fiebert JD, Lavori PW. Effect of Integrated Behavioral Weight Loss Treatment and Problem-Solving Therapy on Body Mass Index and Depressive Symptoms Among Patients With Obesity and Depression: The RAINBOW Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):869-879. doi: 10.1001/jama.2019.0557. |
| 28840096 | Derived | Ma J, Xiao L, Lv N, Rosas LG, Lewis MA, Goldhaber-Fiebert JD, Venditti EM, Snowden MB, Lesser L, Ward E. Profiles of sociodemographic, behavioral, clinical and psychosocial characteristics among primary care patients with comorbid obesity and depression. Prev Med Rep. 2017 Aug 5;8:42-50. doi: 10.1016/j.pmedr.2017.07.010. eCollection 2017 Dec. |
| 26096714 | Derived | Ma J, Yank V, Lv N, Goldhaber-Fiebert JD, Lewis MA, Kramer MK, Snowden MB, Rosas LG, Xiao L, Blonstein AC. Research aimed at improving both mood and weight (RAINBOW) in primary care: A type 1 hybrid design randomized controlled trial. Contemp Clin Trials. 2015 Jul;43:260-78. doi: 10.1016/j.cct.2015.06.010. Epub 2015 Jun 19. |
| NOT COMPLETED |
|
| BG001 |
| Usual Care |
Usual Care. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | 287 women plus 122 men equal to the 409 total sample. | Mean | Standard Deviation | kg/m^2 |
|
| Patient Health Questionnaire 9-items (PHQ-9) | The 9-item Patient Health Questionnaire (PHQ-9) total score is the sum of the scores of the 9 items, ranging from 0 to 27. Higher scores represent more severe depression symptoms. Scores of 5, 10, 15, and 20 represent cut points for mild, moderate, moderately severe and severe depression, respectively. | Mean | Standard Deviation | units on a scale |
|
| Depression Symptom Checklist 20-items (SCL-20) | Depression Symptom Checklist 20 (SCL-20), total average scores of the 20 items with a range from 0 (not at all) to 4 (extremely). Higher scores represent more severe depression symptoms. SCL-20 cutoff points of 1.5 and 2.0 correspond to moderate and severe depression, respectively. | Mean | Standard Deviation | units on a scale |
|
| Taking antidepressant medications | Count of Participants | Participants |
|
| Usual Care |
Usual Care. |
|
|
| Primary | Co-Primary Outcome: Depression Symptom Checklist 20 (SCL-20) Score | Depression Symptom Checklist 20 (SCL-20) questionnaire score. SCL-20, average scores of the 20 items with a range from 0 (not at all) to 4 (extremely). SCL-20 cutoff points scores of ≤0.75, >0.75-1.5, >1.5- 2.0, and >2.0 represent remission, mild depression, moderate depression, and severe depression, respectively. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| Secondary | Body Mass Index | Derived from height and weight measurements | In the case of missing study-measured weight, the closest EHR weight within 3 months of the due date of a missed study visit or self-reported weight (if no EHR weight) was used. So the number of participants analyzed is not consistent with the number in the Participant Flow module. | Posted | Mean | Standard Deviation | kg/m2 | 24 months |
|
|
|
| Secondary | Depression Symptom Checklist 20 (SCL-20) Score | SCL-20 full questionnaire. SCL-20, average scores of the 20 items with a range from 0 (not at all) to 4 (extremely). SCL-20 cutoff points scores of ≤0.75, >0.75-1.5, >1.5- 2.0, and >2.0 represent remission, mild depression, moderate depression, and severe depression, respectively. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
|
|
|
| Secondary | Weight | Weight measurements | In the case of missing study-measured weight, the closest EHR weight within 3 months of the due date of a missed study visit or self-reported weight (if no EHR weight) was used. So the number of participants analyzed is not consistent with the number in the Participant Flow module. | Posted | Mean | Standard Deviation | kg | 12 months |
|
|
|
| Secondary | Weight | Weight measurements | In the case of missing study-measured weight, the closest EHR weight within 3 months of the due date of a missed study visit or self-reported weight (if no EHR weight) was used. So the number of participants analyzed is not consistent with the number in the Participant Flow module. | Posted | Mean | Standard Deviation | kg | 24 months |
|
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| Secondary | Depression Remission (Number of Participants With SCL-20 Scores <0.5) | Depression remission defined by Depression Symptom Checklist 20 (SCL-20) scores <0.5 | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Depression Remission (Number of Participants With SCL-20 Score <0.5) | Depression remission defined by Depression Symptom Checklist 20 (SCL-20) scores <0.5 | Posted | Count of Participants | Participants | 24 months |
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| Secondary | Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline) | Depression treatment response defined by 50% decline in SCL-20 symptom scores | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline) | Depression treatment response defined by 50% decline in SCL-20 symptom scores | Posted | Count of Participants | Participants | 24 months |
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| Secondary | Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline) | 5% or greater weight loss from baseline | In the case of missing study-measured weight, the closest EHR weight within 3 months of the due date of a missed study visit or self-reported weight (if no EHR weight) was used. So the number of participants analyzed is not consistent with the number in the Participant Flow module. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline) | 5% or greater weight loss from baseline | In the case of missing study-measured weight, the closest EHR weight within 3 months of the due date of a missed study visit or self-reported weight (if no EHR weight) was used. So the number of participants analyzed is not consistent with the number in the Participant Flow module. | Posted | Count of Participants | Participants | 24 months |
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| Secondary | Cost-effectiveness | Average annual per person spending on medical care services (2018 real US dollars) | Posted | Mean | 95% Confidence Interval | US dollars | 12 months |
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| Secondary | Obesity-related Psychosocial Functioning (Obesity-related Problem Scale) | Obesity-related Problem Scale, average scores of 8 questions with a range from 0 (no at all) to 3 (extremely). The average score is then multiplied by 100 and divided by 3 to convert to a scale of 0-100, with a higher score indicating more obesity-related problems. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Anxiety (GAD-7) | Self-administered questionnaire. Total scores of the 7 items with a range from 0 (no symptoms) to 21 (most severe symptoms). | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) ) | Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - physical component (PCS) ) Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ) | Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ). Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Disability (Sheehan Disability Scale) | Self-administered Sheehan Disability Scale questionnaire. Sheehan Disability Scale, total scores of the 3 items with a range from 0 (unimpaired) to 30 (highly impaired). Scores of ≥5 on any of the 3 scales (Work/school [0-10], Social life [0-10], and Family life/home responsibilities [0-10]) are associated with significant functional impairment. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Utility-based Health-related Quality of Life (EQ-5D-Activity) | Self-administered questionnaire: Utility-based Health-related Quality of Life - USUAL ACTIVITIES (e.g. work, study, housework, family or leisure activities). A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Utility-based Health-related Quality of Life (EQ-5D-Pain) | Self-administered questionnaire: Utility-based Health-related Quality of Life - PAIN/DISCOMFORT. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression) | Self-administered questionnaire: Utility-based Health-related Quality of Life - Anxiety and depression. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Utility-based Health-related Quality of Life (EQ-5D-Mobility) | Self-administered questionnaire: Utility-based Health-related Quality of Life - Mobility. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Utility-based Health-related Quality of Life (EQ-5D-Self-care) | Self-administered questionnaire: Utility-based Health-related Quality of Life - Self-care. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Sleep Disturbance T-score | Sleep disturbance T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Sleep Impairment T-score | Sleep Impairment T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Change in Activation of Left Amygdala From Baseline Functional Magnetic Resonance Scan at 2 Months (Regulation of Emotion) | Regulation of emotion, specially activation of the amygdala for nonconscious threat-related emotional reactivity, is assessed using fMRI. In the facial emotion viewing paradigm, facial expression stimuli are standardized black and white photographs of 8 identities (4 female, 4 male) with evoked expressions of threat-related emotions (fear, anger), sad-related emotions (sadness) and reward-related emotions (happiness), along with neutral. To assess amygdala activation for the negative affect circuit, our analysis focused on threatening faces only. Threat stimuli included a combination of fear and anger stimuli relative to neutral blocks. A hemodynamic response convolved boxcar function was used to model the BOLD response for each block of emotional expressions to threat and to sadness relative to neutral face blocks. General linear models were then specified for each task to investigate the contrasts of interest. Higher beta-weight indicates higher activation of the amygdala. | Not all participants completed fMRI at baseline and 2 months. In addition, quality control diagnostics included removing scans with incidental findings, scanner artefacts, and signal dropout. So the number of participants analyzed is not consistent with the number in the Participant Flow module. | Posted | Mean | Standard Deviation | beta weights | Baseline, 2 months |
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| Secondary | Change in Activation of Right Amygdala From Baseline Functional Magnetic Resonance Scan at 2 Months (Regulation of Emotion) | Regulation of emotion, specially activation of the amygdala for nonconscious threat-related emotional reactivity, is assessed using fMRI. In the facial emotion viewing paradigm, facial expression stimuli are standardized black and white photographs of 8 identities (4 female, 4 male) with evoked expressions of threat-related emotions (fear, anger), sad-related emotions (sadness) and reward-related emotions (happiness), along with neutral. To assess amygdala activation for the negative affect circuit, our analysis focused on threatening faces only. Threat stimuli included a combination of fear and anger stimuli relative to neutral blocks. A hemodynamic response convolved boxcar function was used to model the BOLD response for each block of emotional expressions to threat and to sadness relative to neutral face blocks. General linear models were then specified for each task to investigate the contrasts of interest. Higher beta-weight indicates higher activation of the amygdala. | Not all participants completed fMRI at baseline and 2 months. In addition, quality control diagnostics included removing scans with incidental findings, scanner artefacts, and signal dropout. So the number of participants analyzed is not consistent with the number in the Participant Flow module. | Posted | Mean | Standard Deviation | beta weights | Baseline, 2 months |
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| Secondary | Obesity-related Psychosocial Functioning (Obesity-related Problem Scale) | Obesity-related Problem Scale, average scores of 8 questions with a range from 0 (no at all) to 3 (extremely). The average score is then multiplied by 100 and divided by 3 to convert to a scale of 0-100, with a higher score indicating more obesity-related problems. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
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| Secondary | Anxiety (GAD-7) | Self-administered questionnaire. Total scores of the 7 items with a range from 0 (no symptoms) to 21 (most severe symptoms). | Posted | Mean | Standard Deviation | score on a scale | 24 months |
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| Secondary | Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) ) | Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - physical component (PCS) ). Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
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| Secondary | Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ) | Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ). Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
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| Secondary | Disability (Sheehan Disability Scale) | Self-administered Sheehan Disability Scale questionnaire. Sheehan Disability Scale, total scores of the 3 items with a range from 0 (unimpaired) to 30 (highly impaired). Scores of ≥5 on any of the 3 scales (Work/school [0-10], Social life [0-10], and Family life/home responsibilities [0-10]) are associated with significant functional impairment. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
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| Secondary | Utility-based Health-related Quality of Life (EQ-5D-Activity) | Self-administered questionnaire: Utility-based Health-related Quality of Life - USUAL ACTIVITIES (e.g. work, study, housework, family or leisure activities). A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
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| Secondary | Utility-based Health-related Quality of Life (EQ-5D-Pain) | Self-administered questionnaire: Utility-based Health-related Quality of Life - PAIN/DISCOMFORT. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
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| Secondary | Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression) | Self-administered questionnaire: Utility-based Health-related Quality of Life - Anxiety and depression. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
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| Secondary | Utility-based Health-related Quality of Life (EQ-5D-Mobility) | Self-administered questionnaire: Utility-based Health-related Quality of Life - Mobility. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
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| Secondary | Utility-based Health-related Quality of Life (EQ-5D-Self-care) | Self-administered questionnaire: Utility-based Health-related Quality of Life - Self-care. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
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| Secondary | Sleep Disturbance T-score | Sleep disturbance T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
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| Secondary | Sleep Impairment T-score | Sleep Impairment T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
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| Secondary | Leisure Time Physical Activity | Physical activity was assessed as metabolic equivalent task (MET) minutes per week of leisure-time physical activity of at least moderate intensity based on the sum of the weighted physical activity minutes for moderate (weight: 4 METs), hard (weight: 6 METs), and very hard (weight: 10 METs) activities from the 7-day Physical Activity Recall. | At 12 months, 169 in RAINBOW intervention and 175 in Usual Care completed the SCL-20, therefore were counted in retention in the Participant Flow module. Among them, 134 in RAINBOW intervention and 139 in Usual care also completed the 7-day Physical Activity Recall at 12 months. | Posted | Mean | Standard Deviation | MET minutes/week | 7-day Physical Activity Recall was administered at 12 months |
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| Secondary | Total Energy Expenditure | Totally energy expenditure was measured using the 7-day Physical Activity Recall and provides estimates of total daily energy expenditures (total energy expenditure = sleep hours × 1 MET + light activity hours × 1.5 METs + moderate activity hours × 4 METs + hard activity hours × 6 METs + very hard activity hours × 10 METs). | At 12 months, 169 in RAINBOW intervention and 175 in Usual Care completed the SCL-20, therefore were counted in retention in the Participant Flow module. Among them, 134 in RAINBOW intervention and 139 in Usual care also completed the 7-day Physical Activity Recall at 12 months. | Posted | Mean | Standard Deviation | kilocalories/kilogram/day | 7-day Physical Activity Recall was administered at 12 months |
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| Secondary | Total Calorie Intake | Total calorie intake was measured using 24-hour dietary recalls and provides total energy intake. | At 12 months, 169 in RAINBOW intervention and 175 in Usual Care completed the SCL-20, therefore were counted in retention in the Participant Flow module. Among them, 131 in RAINBOW intervention and 135 in Usual care also completed the 24-hour diet recalls at 12 months. | Posted | Mean | Standard Deviation | kilocalories/day | One day's 24-hour dietary recall was administered at 12 months |
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| Secondary | DASH (Dietary Approach to Stop Hypertension) Score | Using 24-hour diet recalls, DASH scores were calculated based on combining nine nutrient targets (i.e. total fat, saturated fat, protein, cholesterol, fiber, magnesium, calcium, sodium and potassium). The intermediate target of each nutrient was half-way between the DASH target and population mean (based on the National Health and Nutrition Examination Surveys 2007-2008, latest data available at the inception of the study). For a nutrient, participants reaching the DASH target were assigned one point, those reaching the intermediate target were assigned a half-point, and those not meeting the intermediate target were given 0 points. The DASH score was the sum of points for all nine nutrients and ranged from 0 to 9. DASH score is a measure of diet quality, with higher score indicating higher diet quality | At 12 months, 169 in RAINBOW intervention and 175 in Usual Care completed the SCL-20, therefore were counted in retention in the Participant Flow module. Among them, 131 in RAINBOW intervention and 135 in Usual care also completed the 24-hour diet recalls at 12 months. | Posted | Mean | Standard Deviation | score on a scale | One day's 24-hour dietary recall was administered at 12 months |
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| 0 |
| 204 |
| 17 |
| 204 |
| 42 |
| 204 |
| EG001 | Usual Care | Usual Care. | 0 | 205 | 19 | 205 | 47 | 205 |
| Diabetes diagnosis | Endocrine disorders | Systematic Assessment |
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| Lymphoma diagnosis | Blood and lymphatic system disorders | Systematic Assessment |
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| Cataract surgery | General disorders | Systematic Assessment |
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| Musculoskeletal problems | Musculoskeletal and connective tissue disorders | Systematic Assessment | Adverse Events were monitored in these classifications and cannot be separated. |
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| Nervous system problem | Nervous system disorders | Systematic Assessment |
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| Psychiatric problems | Psychiatric disorders | Systematic Assessment |
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| Reproductive system problems | Reproductive system and breast disorders | Systematic Assessment |
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| Skin problem | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Cardiac problems | Cardiac disorders | Systematic Assessment |
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| Cardiac problems | Cardiac disorders | Systematic Assessment |
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| Ear problem | Ear and labyrinth disorders | Systematic Assessment |
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| Endocrine problems | Endocrine disorders | Systematic Assessment |
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| Digestive system problem | Gastrointestinal disorders | Systematic Assessment |
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| Other problems | General disorders | Systematic Assessment |
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| Musculoskeletal problems | Musculoskeletal and connective tissue disorders | Systematic Assessment | Adverse Events were monitored in these classifications and cannot be separated. |
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| Benign tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Nervous system problem | Nervous system disorders | Systematic Assessment |
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| Psychiatric problem | Psychiatric disorders | Systematic Assessment |
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| Reproductive system problems | Reproductive system and breast disorders | Systematic Assessment |
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| Respiratory problem | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Skin problems | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Vascular problems | Vascular disorders | Systematic Assessment |
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Not provided
Not provided
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012919 | Social Behavior |