Depression, Obesity
Conditions
Keywords
BMI, Depressive symptoms, Integrated therapy, Cardiometabolic risk, Self-regulation, Behavior change, Precision medicine, Lifestyle
Brief 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.
Detailed description
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.
Interventions
BEHAVIORALRAINBOW Intervention Program
Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Washington
University of Pittsburgh
Stanford University
University of Illinois at Chicago
Sutter Health
Palo Alto Medical Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Co-Primary Outcome: Body Mass Index (BMI) | 12 months | Integrated intervention treatment response |
| Co-Primary Outcome: Depression Symptom Checklist 20 (SCL-20) Score | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight | 12 months | Weight measurements |
| Depression Remission (Number of Participants With SCL-20 Scores <0.5) | 12 months | Depression remission defined by Depression Symptom Checklist 20 (SCL-20) scores \<0.5 |
| Depression Remission (Number of Participants With SCL-20 Score <0.5) | 24 months | Depression remission defined by Depression Symptom Checklist 20 (SCL-20) scores \<0.5 |
| Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline) | 12 months | Depression treatment response defined by 50% decline in SCL-20 symptom scores |
| Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline) | 12 months | 5% or greater weight loss from baseline |
| Cost-effectiveness | 12 months | Average annual per person spending on medical care services (2018 real US dollars) |
| Obesity-related Psychosocial Functioning (Obesity-related Problem Scale) | 12 months | 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. |
| Anxiety (GAD-7) | 12 months | Self-administered questionnaire. Total scores of the 7 items with a range from 0 (no symptoms) to 21 (most severe symptoms). |
| Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) ) | 12 months | 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. |
| Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ) | 12 months | 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. |
| Disability (Sheehan Disability Scale) | 12 months | 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. |
| Utility-based Health-related Quality of Life (EQ-5D-Activity) | 12 months | 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. |
| Body Mass Index | 24 months | Derived from height and weight measurements |
| Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression) | 12 months | 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. |
| Utility-based Health-related Quality of Life (EQ-5D-Mobility) | 12 months | 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. |
| Utility-based Health-related Quality of Life (EQ-5D-Self-care) | 12 months | 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. |
| Sleep Disturbance T-score | 12 months | 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. |
| Sleep Impairment T-score | 12 months | 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. |
| Change in Activation of Left Amygdala From Baseline Functional Magnetic Resonance Scan at 2 Months (Regulation of Emotion) | Baseline, 2 months | 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. |
| Change in Activation of Right Amygdala From Baseline Functional Magnetic Resonance Scan at 2 Months (Regulation of Emotion) | Baseline, 2 months | 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. |
| Leisure Time Physical Activity | 7-day Physical Activity Recall was administered at 12 months | 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. |
| Total Energy Expenditure | 7-day Physical Activity Recall was administered at 12 months | 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). |
| Total Calorie Intake | One day's 24-hour dietary recall was administered at 12 months | Total calorie intake was measured using 24-hour dietary recalls and provides total energy intake. |
| DASH (Dietary Approach to Stop Hypertension) Score | One day's 24-hour dietary recall was administered at 12 months | 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 |
| Utility-based Health-related Quality of Life (EQ-5D-Pain) | 12 months | 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. |
| Depression Symptom Checklist 20 (SCL-20) Score | 24 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 204 |
| Usual Care Usual Care. | 205 |
| Total | 409 |
Baseline characteristics
| Characteristic | RAINBOW Intervention Program | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 50.9 years STANDARD_DEVIATION 12.2 | 51.0 years STANDARD_DEVIATION 12.1 | 51.0 years STANDARD_DEVIATION 11.9 |
| Body Mass Index (BMI) All | 36.7 kg/m^2 STANDARD_DEVIATION 6.9 | 36.7 kg/m^2 STANDARD_DEVIATION 6.4 | 36.6 kg/m^2 STANDARD_DEVIATION 5.8 |
| Body Mass Index (BMI) Men | 36.4 kg/m^2 STANDARD_DEVIATION 7.5 | 35.7 kg/m^2 STANDARD_DEVIATION 6.6 | 35.1 kg/m^2 STANDARD_DEVIATION 5.5 |
| Body Mass Index (BMI) Women | 36.8 kg/m^2 STANDARD_DEVIATION 6.6 | 37.0 kg/m^2 STANDARD_DEVIATION 6.2 | 37.3 kg/m^2 STANDARD_DEVIATION 5.9 |
| Depression Symptom Checklist 20-items (SCL-20) | 1.5 units on a scale STANDARD_DEVIATION 0.5 | 1.5 units on a scale STANDARD_DEVIATION 0.5 | 1.5 units on a scale STANDARD_DEVIATION 0.6 |
| Patient Health Questionnaire 9-items (PHQ-9) | 14.1 units on a scale STANDARD_DEVIATION 3.2 | 13.8 units on a scale STANDARD_DEVIATION 3.1 | 13.5 units on a scale STANDARD_DEVIATION 3 |
| Race/Ethnicity, Customized African American | 3 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian/Pacific Islander | 20 Participants | 40 Participants | 20 Participants |
| Race/Ethnicity, Customized Hispanic | 26 Participants | 56 Participants | 30 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 147 Participants | 289 Participants | 142 Participants |
| Race/Ethnicity, Customized Other | 8 Participants | 18 Participants | 10 Participants |
| Region of Enrollment United States | 204 participants | 409 participants | 205 participants |
| Sex: Female, Male Female | 144 Participants | 287 Participants | 143 Participants |
| Sex: Female, Male Male | 60 Participants | 122 Participants | 62 Participants |
| Taking antidepressant medications | 85 Participants | 169 Participants | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 204 | 0 / 205 |
| other Total, other adverse events | 42 / 204 | 47 / 205 |
| serious Total, serious adverse events | 17 / 204 | 19 / 205 |
Outcome results
Primary
Co-Primary Outcome: Body Mass Index (BMI)
Integrated intervention treatment response
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Co-Primary Outcome: Body Mass Index (BMI) | 35.9 kg/m^2 | Standard Deviation 7.1 |
| Usual Care | Co-Primary Outcome: Body Mass Index (BMI) | 36.6 kg/m^2 | Standard Deviation 6 |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Co-Primary Outcome: Depression Symptom Checklist 20 (SCL-20) Score | 1.1 score on a scale | Standard Deviation 0.7 |
| Usual Care | Co-Primary Outcome: Depression Symptom Checklist 20 (SCL-20) Score | 1.4 score on a scale | Standard Deviation 0.9 |
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).
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Anxiety (GAD-7) | 4.6 score on a scale | Standard Deviation 3.8 |
| Usual Care | Anxiety (GAD-7) | 6.1 score on a scale | Standard Deviation 4.6 |
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).
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Anxiety (GAD-7) | 4.8 score on a scale | Standard Deviation 4.8 |
| Usual Care | Anxiety (GAD-7) | 5.9 score on a scale | Standard Deviation 4.8 |
Secondary
Body Mass Index
Derived from height and weight measurements
Time frame: 24 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Body Mass Index | 36.2 kg/m2 | Standard Deviation 7.3 |
| Usual Care | Body Mass Index | 36.2 kg/m2 | Standard Deviation 6.5 |
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.
Time frame: Baseline, 2 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Change in Activation of Left Amygdala From Baseline Functional Magnetic Resonance Scan at 2 Months (Regulation of Emotion) | -0.32 beta weights | Standard Deviation 1.25 |
| Usual Care | Change in Activation of Left Amygdala From Baseline Functional Magnetic Resonance Scan at 2 Months (Regulation of Emotion) | 0.43 beta weights | Standard Deviation 1.69 |
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.
Time frame: Baseline, 2 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Change in Activation of Right Amygdala From Baseline Functional Magnetic Resonance Scan at 2 Months (Regulation of Emotion) | -0.07 beta weights | Standard Deviation 1.38 |
| Usual Care | Change in Activation of Right Amygdala From Baseline Functional Magnetic Resonance Scan at 2 Months (Regulation of Emotion) | 0.01 beta weights | Standard Deviation 0.84 |
Secondary
Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline)
5% or greater weight loss from baseline
Time frame: 24 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RAINBOW Intervention Program | Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline) | 42 Participants |
| Usual Care | Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline) | 37 Participants |
Secondary
Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline)
5% or greater weight loss from baseline
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RAINBOW Intervention Program | Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline) | 51 Participants |
| Usual Care | Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline) | 27 Participants |
Secondary
Cost-effectiveness
Average annual per person spending on medical care services (2018 real US dollars)
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| RAINBOW Intervention Program | Cost-effectiveness | 1994 US dollars |
| Usual Care | Cost-effectiveness | 1773 US dollars |
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
Time frame: One day's 24-hour dietary recall was administered at 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | DASH (Dietary Approach to Stop Hypertension) Score | 2.4 score on a scale | Standard Deviation 1.3 |
| Usual Care | DASH (Dietary Approach to Stop Hypertension) Score | 2.5 score on a scale | Standard Deviation 1.4 |
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
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RAINBOW Intervention Program | Depression Remission (Number of Participants With SCL-20 Score <0.5) | 31 Participants |
| Usual Care | Depression Remission (Number of Participants With SCL-20 Score <0.5) | 20 Participants |
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
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RAINBOW Intervention Program | Depression Remission (Number of Participants With SCL-20 Scores <0.5) | 30 Participants |
| Usual Care | Depression Remission (Number of Participants With SCL-20 Scores <0.5) | 23 Participants |
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.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Depression Symptom Checklist 20 (SCL-20) Score | 1.3 score on a scale | Standard Deviation 0.8 |
| Usual Care | Depression Symptom Checklist 20 (SCL-20) Score | 1.4 score on a scale | Standard Deviation 0.9 |
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
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RAINBOW Intervention Program | Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline) | 49 Participants |
| Usual Care | Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline) | 38 Participants |
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
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RAINBOW Intervention Program | Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline) | 40 Participants |
| Usual Care | Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline) | 39 Participants |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Disability (Sheehan Disability Scale) | 6.8 score on a scale | Standard Deviation 6.7 |
| Usual Care | Disability (Sheehan Disability Scale) | 8.4 score on a scale | Standard Deviation 6.2 |
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.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Disability (Sheehan Disability Scale) | 6 score on a scale | Standard Deviation 6 |
| Usual Care | Disability (Sheehan Disability Scale) | 6.9 score on a scale | Standard Deviation 6.1 |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ) | 45 score on a scale | Standard Deviation 9.6 |
| Usual Care | Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ) | 43.3 score on a scale | Standard Deviation 9.5 |
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.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ) | 45.9 score on a scale | Standard Deviation 9.9 |
| Usual Care | Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ) | 43.9 score on a scale | Standard Deviation 9.8 |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) ) | 47.1 score on a scale | Standard Deviation 8.7 |
| Usual Care | Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) ) | 46.3 score on a scale | Standard Deviation 8.6 |
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.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) ) | 47.3 score on a scale | Standard Deviation 9.1 |
| Usual Care | Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) ) | 45.4 score on a scale | Standard Deviation 9.3 |
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.
Time frame: 7-day Physical Activity Recall was administered at 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Leisure Time Physical Activity | 704.5 MET minutes/week | Standard Deviation 984.4 |
| Usual Care | Leisure Time Physical Activity | 752.4 MET minutes/week | Standard Deviation 1111.1 |
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.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Obesity-related Psychosocial Functioning (Obesity-related Problem Scale) | 51.1 score on a scale | Standard Deviation 30.6 |
| Usual Care | Obesity-related Psychosocial Functioning (Obesity-related Problem Scale) | 50.6 score on a scale | Standard Deviation 28.6 |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Obesity-related Psychosocial Functioning (Obesity-related Problem Scale) | 54.3 score on a scale | Standard Deviation 25.9 |
| Usual Care | Obesity-related Psychosocial Functioning (Obesity-related Problem Scale) | 56.1 score on a scale | Standard Deviation 27.2 |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Sleep Disturbance T-score | 53.4 score on a scale | Standard Deviation 9.3 |
| Usual Care | Sleep Disturbance T-score | 55.1 score on a scale | Standard Deviation 8.5 |
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.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Sleep Disturbance T-score | 52.9 score on a scale | Standard Deviation 9.7 |
| Usual Care | Sleep Disturbance T-score | 55 score on a scale | Standard Deviation 8.7 |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Sleep Impairment T-score | 53.4 score on a scale | Standard Deviation 9.6 |
| Usual Care | Sleep Impairment T-score | 55.5 score on a scale | Standard Deviation 9.2 |
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.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Sleep Impairment T-score | 52.2 score on a scale | Standard Deviation 9.7 |
| Usual Care | Sleep Impairment T-score | 54.2 score on a scale | Standard Deviation 9 |
Secondary
Total Calorie Intake
Total calorie intake was measured using 24-hour dietary recalls and provides total energy intake.
Time frame: One day's 24-hour dietary recall was administered at 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Total Calorie Intake | 1592.4 kilocalories/day | Standard Deviation 587 |
| Usual Care | Total Calorie Intake | 1591.3 kilocalories/day | Standard Deviation 621.9 |
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).
Time frame: 7-day Physical Activity Recall was administered at 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Total Energy Expenditure | 33.1 kilocalories/kilogram/day | Standard Deviation 2.2 |
| Usual Care | Total Energy Expenditure | 33.5 kilocalories/kilogram/day | Standard Deviation 2.5 |
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.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Utility-based Health-related Quality of Life (EQ-5D-Activity) | 1.5 score on a scale | Standard Deviation 0.8 |
| Usual Care | Utility-based Health-related Quality of Life (EQ-5D-Activity) | 1.7 score on a scale | Standard Deviation 0.9 |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Utility-based Health-related Quality of Life (EQ-5D-Activity) | 1.4 score on a scale | Standard Deviation 0.7 |
| Usual Care | Utility-based Health-related Quality of Life (EQ-5D-Activity) | 1.6 score on a scale | Standard Deviation 0.8 |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression) | 2.1 score on a scale | Standard Deviation 0.9 |
| Usual Care | Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression) | 2.1 score on a scale | Standard Deviation 0.8 |
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.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression) | 2 score on a scale | Standard Deviation 0.9 |
| Usual Care | Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression) | 2.2 score on a scale | Standard Deviation 0.9 |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Utility-based Health-related Quality of Life (EQ-5D-Mobility) | 1.5 score on a scale | Standard Deviation 0.7 |
| Usual Care | Utility-based Health-related Quality of Life (EQ-5D-Mobility) | 1.5 score on a scale | Standard Deviation 0.7 |
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.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Utility-based Health-related Quality of Life (EQ-5D-Mobility) | 1.6 score on a scale | Standard Deviation 0.9 |
| Usual Care | Utility-based Health-related Quality of Life (EQ-5D-Mobility) | 1.6 score on a scale | Standard Deviation 0.9 |
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.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Utility-based Health-related Quality of Life (EQ-5D-Pain) | 2 score on a scale | Standard Deviation 0.8 |
| Usual Care | Utility-based Health-related Quality of Life (EQ-5D-Pain) | 2.3 score on a scale | Standard Deviation 0.9 |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Utility-based Health-related Quality of Life (EQ-5D-Pain) | 2.0 score on a scale | Standard Deviation 0.8 |
| Usual Care | Utility-based Health-related Quality of Life (EQ-5D-Pain) | 2.1 score on a scale | Standard Deviation 0.8 |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Utility-based Health-related Quality of Life (EQ-5D-Self-care) | 1.1 score on a scale | Standard Deviation 0.3 |
| Usual Care | Utility-based Health-related Quality of Life (EQ-5D-Self-care) | 1.1 score on a scale | Standard Deviation 0.4 |
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.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Utility-based Health-related Quality of Life (EQ-5D-Self-care) | 1.2 score on a scale | Standard Deviation 0.4 |
| Usual Care | Utility-based Health-related Quality of Life (EQ-5D-Self-care) | 1.2 score on a scale | Standard Deviation 0.5 |
Secondary
Weight
Weight measurements
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Weight | 100.8 kg | Standard Deviation 22.8 |
| Usual Care | Weight | 103.4 kg | Standard Deviation 20.9 |
Secondary
Weight
Weight measurements
Time frame: 24 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RAINBOW Intervention Program | Weight | 101.8 kg | Standard Deviation 24 |
| Usual Care | Weight | 102.4 kg | Standard Deviation 22.4 |