Trial Outcomes & Findings for Research Aimed at Improving Both Mood and Weight (NCT NCT02246413)
NCT ID: NCT02246413
Last Updated: 2024-04-26
Results Overview
Integrated intervention treatment response
COMPLETED
NA
409 participants
12 months
2024-04-26
Participant Flow
Participant milestones
| Measure |
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
|
Usual Care
Usual Care.
|
|---|---|---|
|
12-months (Primary Outcome)
STARTED
|
204
|
205
|
|
12-months (Primary Outcome)
COMPLETED
|
169
|
175
|
|
12-months (Primary Outcome)
NOT COMPLETED
|
35
|
30
|
|
24-months (Secondary Outcome)
STARTED
|
204
|
205
|
|
24-months (Secondary Outcome)
COMPLETED
|
153
|
173
|
|
24-months (Secondary Outcome)
NOT COMPLETED
|
51
|
32
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
287 women plus 122 men equal to the 409 total sample.
Baseline characteristics by cohort
| Measure |
RAINBOW Intervention Program
n=204 Participants
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
|
Usual Care
n=205 Participants
Usual Care.
|
Total
n=409 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.9 years
STANDARD_DEVIATION 12.2 • n=204 Participants
|
51.0 years
STANDARD_DEVIATION 11.9 • n=205 Participants
|
51.0 years
STANDARD_DEVIATION 12.1 • n=409 Participants
|
|
Sex: Female, Male
Female
|
144 Participants
n=204 Participants
|
143 Participants
n=205 Participants
|
287 Participants
n=409 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=204 Participants
|
62 Participants
n=205 Participants
|
122 Participants
n=409 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
147 Participants
n=204 Participants
|
142 Participants
n=205 Participants
|
289 Participants
n=409 Participants
|
|
Race/Ethnicity, Customized
African American
|
3 Participants
n=204 Participants
|
3 Participants
n=205 Participants
|
6 Participants
n=409 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
20 Participants
n=204 Participants
|
20 Participants
n=205 Participants
|
40 Participants
n=409 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
26 Participants
n=204 Participants
|
30 Participants
n=205 Participants
|
56 Participants
n=409 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 Participants
n=204 Participants
|
10 Participants
n=205 Participants
|
18 Participants
n=409 Participants
|
|
Region of Enrollment
United States
|
204 participants
n=204 Participants
|
205 participants
n=205 Participants
|
409 participants
n=409 Participants
|
|
Body Mass Index (BMI)
All
|
36.7 kg/m^2
STANDARD_DEVIATION 6.9 • n=204 Participants • 287 women plus 122 men equal to the 409 total sample.
|
36.6 kg/m^2
STANDARD_DEVIATION 5.8 • n=205 Participants • 287 women plus 122 men equal to the 409 total sample.
|
36.7 kg/m^2
STANDARD_DEVIATION 6.4 • n=409 Participants • 287 women plus 122 men equal to the 409 total sample.
|
|
Body Mass Index (BMI)
Women
|
36.8 kg/m^2
STANDARD_DEVIATION 6.6 • n=144 Participants • 287 women plus 122 men equal to the 409 total sample.
|
37.3 kg/m^2
STANDARD_DEVIATION 5.9 • n=143 Participants • 287 women plus 122 men equal to the 409 total sample.
|
37.0 kg/m^2
STANDARD_DEVIATION 6.2 • n=287 Participants • 287 women plus 122 men equal to the 409 total sample.
|
|
Body Mass Index (BMI)
Men
|
36.4 kg/m^2
STANDARD_DEVIATION 7.5 • n=60 Participants • 287 women plus 122 men equal to the 409 total sample.
|
35.1 kg/m^2
STANDARD_DEVIATION 5.5 • n=62 Participants • 287 women plus 122 men equal to the 409 total sample.
|
35.7 kg/m^2
STANDARD_DEVIATION 6.6 • n=122 Participants • 287 women plus 122 men equal to the 409 total sample.
|
|
Patient Health Questionnaire 9-items (PHQ-9)
|
14.1 units on a scale
STANDARD_DEVIATION 3.2 • n=204 Participants
|
13.5 units on a scale
STANDARD_DEVIATION 3.0 • n=205 Participants
|
13.8 units on a scale
STANDARD_DEVIATION 3.1 • n=409 Participants
|
|
Depression Symptom Checklist 20-items (SCL-20)
|
1.5 units on a scale
STANDARD_DEVIATION 0.5 • n=204 Participants
|
1.5 units on a scale
STANDARD_DEVIATION 0.6 • n=205 Participants
|
1.5 units on a scale
STANDARD_DEVIATION 0.5 • n=409 Participants
|
|
Taking antidepressant medications
|
85 Participants
n=204 Participants
|
84 Participants
n=205 Participants
|
169 Participants
n=409 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 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.
Integrated intervention treatment response
Outcome measures
| Measure |
RAINBOW Intervention Program
n=183 Participants
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
|
Usual Care
n=184 Participants
Usual Care.
|
|---|---|---|
|
Co-Primary Outcome: Body Mass Index (BMI)
|
35.9 kg/m^2
Standard Deviation 7.1
|
36.6 kg/m^2
Standard Deviation 6.0
|
PRIMARY outcome
Timeframe: 12 monthsDepression 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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=169 Participants
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
|
Usual Care
n=175 Participants
Usual Care.
|
|---|---|---|
|
Co-Primary Outcome: Depression Symptom Checklist 20 (SCL-20) Score
|
1.1 score on a scale
Standard Deviation 0.7
|
1.4 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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.
Derived from height and weight measurements
Outcome measures
| Measure |
RAINBOW Intervention Program
n=178 Participants
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
|
Usual Care
n=179 Participants
Usual Care.
|
|---|---|---|
|
Body Mass Index
|
36.2 kg/m2
Standard Deviation 7.3
|
36.2 kg/m2
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: 24 monthsSCL-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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=153 Participants
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
|
Usual Care
n=173 Participants
Usual Care.
|
|---|---|---|
|
Depression Symptom Checklist 20 (SCL-20) Score
|
1.3 score on a scale
Standard Deviation 0.8
|
1.4 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
Weight measurements
Outcome measures
| Measure |
RAINBOW Intervention Program
n=183 Participants
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
|
Usual Care
n=184 Participants
Usual Care.
|
|---|---|---|
|
Weight
|
100.8 kg
Standard Deviation 22.8
|
103.4 kg
Standard Deviation 20.9
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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.
Weight measurements
Outcome measures
| Measure |
RAINBOW Intervention Program
n=178 Participants
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
|
Usual Care
n=179 Participants
Usual Care.
|
|---|---|---|
|
Weight
|
101.8 kg
Standard Deviation 24
|
102.4 kg
Standard Deviation 22.4
|
SECONDARY outcome
Timeframe: 12 monthsDepression remission defined by Depression Symptom Checklist 20 (SCL-20) scores \<0.5
Outcome measures
| Measure |
RAINBOW Intervention Program
n=169 Participants
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
|
Usual Care
n=175 Participants
Usual Care.
|
|---|---|---|
|
Depression Remission (Number of Participants With SCL-20 Scores <0.5)
|
30 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 24 monthsDepression remission defined by Depression Symptom Checklist 20 (SCL-20) scores \<0.5
Outcome measures
| Measure |
RAINBOW Intervention Program
n=153 Participants
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
|
Usual Care
n=173 Participants
Usual Care.
|
|---|---|---|
|
Depression Remission (Number of Participants With SCL-20 Score <0.5)
|
31 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 12 monthsDepression treatment response defined by 50% decline in SCL-20 symptom scores
Outcome measures
| Measure |
RAINBOW Intervention Program
n=169 Participants
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
|
Usual Care
n=175 Participants
Usual Care.
|
|---|---|---|
|
Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline)
|
49 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: 24 monthsDepression treatment response defined by 50% decline in SCL-20 symptom scores
Outcome measures
| Measure |
RAINBOW Intervention Program
n=153 Participants
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
|
Usual Care
n=173 Participants
Usual Care.
|
|---|---|---|
|
Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline)
|
40 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
5% or greater weight loss from baseline
Outcome measures
| Measure |
RAINBOW Intervention Program
n=183 Participants
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
|
Usual Care
n=184 Participants
Usual Care.
|
|---|---|---|
|
Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline)
|
51 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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.
5% or greater weight loss from baseline
Outcome measures
| Measure |
RAINBOW Intervention Program
n=178 Participants
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
|
Usual Care
n=179 Participants
Usual Care.
|
|---|---|---|
|
Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline)
|
42 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: 12 monthsAverage annual per person spending on medical care services (2018 real US dollars)
Outcome measures
| Measure |
RAINBOW Intervention Program
n=178 Participants
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
|
Usual Care
n=180 Participants
Usual Care.
|
|---|---|---|
|
Cost-effectiveness
|
1994 US dollars
Interval 1473.0 to 2515.0
|
1773 US dollars
Interval 1209.0 to 2337.0
|
SECONDARY outcome
Timeframe: 12 monthsObesity-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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=132 Participants
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
|
Usual Care
n=137 Participants
Usual Care.
|
|---|---|---|
|
Obesity-related Psychosocial Functioning (Obesity-related Problem Scale)
|
54.3 score on a scale
Standard Deviation 25.9
|
56.1 score on a scale
Standard Deviation 27.2
|
SECONDARY outcome
Timeframe: 12 monthsSelf-administered questionnaire. Total scores of the 7 items with a range from 0 (no symptoms) to 21 (most severe symptoms).
Outcome measures
| Measure |
RAINBOW Intervention Program
n=131 Participants
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
|
Usual Care
n=137 Participants
Usual Care.
|
|---|---|---|
|
Anxiety (GAD-7)
|
4.6 score on a scale
Standard Deviation 3.8
|
6.1 score on a scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: 12 monthsSelf-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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=132 Participants
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
|
Usual Care
n=138 Participants
Usual Care.
|
|---|---|---|
|
Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) )
|
47.1 score on a scale
Standard Deviation 8.7
|
46.3 score on a scale
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: 12 monthsSelf-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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=132 Participants
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
|
Usual Care
n=138 Participants
Usual Care.
|
|---|---|---|
|
Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) )
|
45 score on a scale
Standard Deviation 9.6
|
43.3 score on a scale
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: 12 monthsSelf-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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=129 Participants
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
|
Usual Care
n=132 Participants
Usual Care.
|
|---|---|---|
|
Disability (Sheehan Disability Scale)
|
6.8 score on a scale
Standard Deviation 6.7
|
8.4 score on a scale
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: 12 monthsSelf-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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=132 Participants
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
|
Usual Care
n=138 Participants
Usual Care.
|
|---|---|---|
|
Utility-based Health-related Quality of Life (EQ-5D-Activity)
|
1.4 score on a scale
Standard Deviation 0.7
|
1.6 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 12 monthsSelf-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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=132 Participants
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
|
Usual Care
n=138 Participants
Usual Care.
|
|---|---|---|
|
Utility-based Health-related Quality of Life (EQ-5D-Pain)
|
2.0 score on a scale
Standard Deviation 0.8
|
2.1 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 12 monthsSelf-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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=132 Participants
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
|
Usual Care
n=138 Participants
Usual Care.
|
|---|---|---|
|
Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression)
|
2.1 score on a scale
Standard Deviation 0.9
|
2.1 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 12 monthsSelf-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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=132 Participants
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
|
Usual Care
n=138 Participants
Usual Care.
|
|---|---|---|
|
Utility-based Health-related Quality of Life (EQ-5D-Mobility)
|
1.5 score on a scale
Standard Deviation 0.7
|
1.5 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 12 monthsSelf-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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=132 Participants
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
|
Usual Care
n=138 Participants
Usual Care.
|
|---|---|---|
|
Utility-based Health-related Quality of Life (EQ-5D-Self-care)
|
1.1 score on a scale
Standard Deviation 0.3
|
1.1 score on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 12 monthsSleep 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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=132 Participants
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
|
Usual Care
n=137 Participants
Usual Care.
|
|---|---|---|
|
Sleep Disturbance T-score
|
53.4 score on a scale
Standard Deviation 9.3
|
55.1 score on a scale
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: 12 monthsSleep 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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=132 Participants
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
|
Usual Care
n=137 Participants
Usual Care.
|
|---|---|---|
|
Sleep Impairment T-score
|
53.4 score on a scale
Standard Deviation 9.6
|
55.5 score on a scale
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: Baseline, 2 monthsPopulation: 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.
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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=35 Participants
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
|
Usual Care
n=28 Participants
Usual Care.
|
|---|---|---|
|
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
|
0.43 beta weights
Standard Deviation 1.69
|
SECONDARY outcome
Timeframe: Baseline, 2 monthsPopulation: 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.
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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=35 Participants
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
|
Usual Care
n=28 Participants
Usual Care.
|
|---|---|---|
|
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
|
0.01 beta weights
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: 24 monthsObesity-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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=106 Participants
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
|
Usual Care
n=127 Participants
Usual Care.
|
|---|---|---|
|
Obesity-related Psychosocial Functioning (Obesity-related Problem Scale)
|
51.1 score on a scale
Standard Deviation 30.6
|
50.6 score on a scale
Standard Deviation 28.6
|
SECONDARY outcome
Timeframe: 24 monthsSelf-administered questionnaire. Total scores of the 7 items with a range from 0 (no symptoms) to 21 (most severe symptoms).
Outcome measures
| Measure |
RAINBOW Intervention Program
n=106 Participants
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
|
Usual Care
n=128 Participants
Usual Care.
|
|---|---|---|
|
Anxiety (GAD-7)
|
4.8 score on a scale
Standard Deviation 4.8
|
5.9 score on a scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: 24 monthsSelf-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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=106 Participants
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
|
Usual Care
n=127 Participants
Usual Care.
|
|---|---|---|
|
Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) )
|
47.3 score on a scale
Standard Deviation 9.1
|
45.4 score on a scale
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: 24 monthsSelf-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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=106 Participants
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
|
Usual Care
n=127 Participants
Usual Care.
|
|---|---|---|
|
Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) )
|
45.9 score on a scale
Standard Deviation 9.9
|
43.9 score on a scale
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: 24 monthsSelf-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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=100 Participants
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
|
Usual Care
n=124 Participants
Usual Care.
|
|---|---|---|
|
Disability (Sheehan Disability Scale)
|
6 score on a scale
Standard Deviation 6
|
6.9 score on a scale
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: 24 monthsSelf-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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=106 Participants
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
|
Usual Care
n=128 Participants
Usual Care.
|
|---|---|---|
|
Utility-based Health-related Quality of Life (EQ-5D-Activity)
|
1.5 score on a scale
Standard Deviation 0.8
|
1.7 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 24 monthsSelf-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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=106 Participants
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
|
Usual Care
n=128 Participants
Usual Care.
|
|---|---|---|
|
Utility-based Health-related Quality of Life (EQ-5D-Pain)
|
2 score on a scale
Standard Deviation 0.8
|
2.3 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 24 monthsSelf-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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=106 Participants
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
|
Usual Care
n=128 Participants
Usual Care.
|
|---|---|---|
|
Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression)
|
2 score on a scale
Standard Deviation 0.9
|
2.2 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 24 monthsSelf-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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=106 Participants
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
|
Usual Care
n=127 Participants
Usual Care.
|
|---|---|---|
|
Utility-based Health-related Quality of Life (EQ-5D-Mobility)
|
1.6 score on a scale
Standard Deviation 0.9
|
1.6 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 24 monthsSelf-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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=106 Participants
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
|
Usual Care
n=128 Participants
Usual Care.
|
|---|---|---|
|
Utility-based Health-related Quality of Life (EQ-5D-Self-care)
|
1.2 score on a scale
Standard Deviation 0.4
|
1.2 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 24 monthsSleep 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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=106 Participants
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
|
Usual Care
n=127 Participants
Usual Care.
|
|---|---|---|
|
Sleep Disturbance T-score
|
52.9 score on a scale
Standard Deviation 9.7
|
55 score on a scale
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: 24 monthsSleep 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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=106 Participants
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
|
Usual Care
n=127 Participants
Usual Care.
|
|---|---|---|
|
Sleep Impairment T-score
|
52.2 score on a scale
Standard Deviation 9.7
|
54.2 score on a scale
Standard Deviation 9
|
SECONDARY outcome
Timeframe: 7-day Physical Activity Recall was administered at 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=134 Participants
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
|
Usual Care
n=139 Participants
Usual Care.
|
|---|---|---|
|
Leisure Time Physical Activity
|
704.5 MET minutes/week
Standard Deviation 984.4
|
752.4 MET minutes/week
Standard Deviation 1111.1
|
SECONDARY outcome
Timeframe: 7-day Physical Activity Recall was administered at 12 monthsPopulation: 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.
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).
Outcome measures
| Measure |
RAINBOW Intervention Program
n=134 Participants
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
|
Usual Care
n=139 Participants
Usual Care.
|
|---|---|---|
|
Total Energy Expenditure
|
33.1 kilocalories/kilogram/day
Standard Deviation 2.2
|
33.5 kilocalories/kilogram/day
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: One day's 24-hour dietary recall was administered at 12 monthsPopulation: 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.
Total calorie intake was measured using 24-hour dietary recalls and provides total energy intake.
Outcome measures
| Measure |
RAINBOW Intervention Program
n=131 Participants
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
|
Usual Care
n=135 Participants
Usual Care.
|
|---|---|---|
|
Total Calorie Intake
|
1592.4 kilocalories/day
Standard Deviation 587.0
|
1591.3 kilocalories/day
Standard Deviation 621.9
|
SECONDARY outcome
Timeframe: One day's 24-hour dietary recall was administered at 12 monthsPopulation: 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.
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
Outcome measures
| Measure |
RAINBOW Intervention Program
n=131 Participants
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
|
Usual Care
n=135 Participants
Usual Care.
|
|---|---|---|
|
DASH (Dietary Approach to Stop Hypertension) Score
|
2.4 score on a scale
Standard Deviation 1.3
|
2.5 score on a scale
Standard Deviation 1.4
|
Adverse Events
RAINBOW Intervention Program
Usual Care
Serious adverse events
| Measure |
RAINBOW Intervention Program
n=204 participants at risk
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
|
Usual Care
n=205 participants at risk
Usual Care.
|
|---|---|---|
|
Gastrointestinal disorders
Digestive system problem
|
0.98%
2/204 • Number of events 2 • Primary and secondary outcome period (up to 24-months)
|
2.0%
4/205 • Number of events 5 • Primary and secondary outcome period (up to 24-months)
|
|
Endocrine disorders
Diabetes diagnosis
|
0.00%
0/204 • Primary and secondary outcome period (up to 24-months)
|
0.49%
1/205 • Number of events 1 • Primary and secondary outcome period (up to 24-months)
|
|
Blood and lymphatic system disorders
Lymphoma diagnosis
|
0.49%
1/204 • Number of events 1 • Primary and secondary outcome period (up to 24-months)
|
0.98%
2/205 • Number of events 2 • Primary and secondary outcome period (up to 24-months)
|
|
General disorders
Cataract surgery
|
0.00%
0/204 • Primary and secondary outcome period (up to 24-months)
|
0.00%
0/205 • Primary and secondary outcome period (up to 24-months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal problems
|
3.4%
7/204 • Number of events 7 • Primary and secondary outcome period (up to 24-months)
|
4.4%
9/205 • Number of events 11 • Primary and secondary outcome period (up to 24-months)
|
|
Nervous system disorders
Nervous system problem
|
0.00%
0/204 • Primary and secondary outcome period (up to 24-months)
|
0.49%
1/205 • Number of events 1 • Primary and secondary outcome period (up to 24-months)
|
|
Psychiatric disorders
Psychiatric problems
|
0.98%
2/204 • Number of events 2 • Primary and secondary outcome period (up to 24-months)
|
0.00%
0/205 • Primary and secondary outcome period (up to 24-months)
|
|
Reproductive system and breast disorders
Reproductive system problems
|
0.49%
1/204 • Number of events 1 • Primary and secondary outcome period (up to 24-months)
|
0.98%
2/205 • Number of events 2 • Primary and secondary outcome period (up to 24-months)
|
|
Skin and subcutaneous tissue disorders
Skin problem
|
0.49%
1/204 • Number of events 1 • Primary and secondary outcome period (up to 24-months)
|
0.49%
1/205 • Number of events 1 • Primary and secondary outcome period (up to 24-months)
|
|
Cardiac disorders
Cardiac problems
|
2.0%
4/204 • Number of events 4 • Primary and secondary outcome period (up to 24-months)
|
0.00%
0/205 • Primary and secondary outcome period (up to 24-months)
|
Other adverse events
| Measure |
RAINBOW Intervention Program
n=204 participants at risk
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
|
Usual Care
n=205 participants at risk
Usual Care.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphatic problems
|
1.5%
3/204 • Number of events 3 • Primary and secondary outcome period (up to 24-months)
|
0.00%
0/205 • Primary and secondary outcome period (up to 24-months)
|
|
Cardiac disorders
Cardiac problems
|
1.5%
3/204 • Number of events 3 • Primary and secondary outcome period (up to 24-months)
|
2.4%
5/205 • Number of events 5 • Primary and secondary outcome period (up to 24-months)
|
|
Ear and labyrinth disorders
Ear problem
|
0.00%
0/204 • Primary and secondary outcome period (up to 24-months)
|
0.00%
0/205 • Primary and secondary outcome period (up to 24-months)
|
|
Endocrine disorders
Endocrine problems
|
0.49%
1/204 • Number of events 1 • Primary and secondary outcome period (up to 24-months)
|
0.49%
1/205 • Number of events 1 • Primary and secondary outcome period (up to 24-months)
|
|
Gastrointestinal disorders
Digestive system problem
|
2.5%
5/204 • Number of events 6 • Primary and secondary outcome period (up to 24-months)
|
3.9%
8/205 • Number of events 9 • Primary and secondary outcome period (up to 24-months)
|
|
General disorders
Other problems
|
0.00%
0/204 • Primary and secondary outcome period (up to 24-months)
|
0.00%
0/205 • Primary and secondary outcome period (up to 24-months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal problems
|
10.8%
22/204 • Number of events 30 • Primary and secondary outcome period (up to 24-months)
|
11.7%
24/205 • Number of events 30 • Primary and secondary outcome period (up to 24-months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign tumor
|
0.00%
0/204 • Primary and secondary outcome period (up to 24-months)
|
0.00%
0/205 • Primary and secondary outcome period (up to 24-months)
|
|
Nervous system disorders
Nervous system problem
|
2.5%
5/204 • Number of events 5 • Primary and secondary outcome period (up to 24-months)
|
2.9%
6/205 • Number of events 11 • Primary and secondary outcome period (up to 24-months)
|
|
Psychiatric disorders
Psychiatric problem
|
0.49%
1/204 • Number of events 1 • Primary and secondary outcome period (up to 24-months)
|
0.49%
1/205 • Number of events 1 • Primary and secondary outcome period (up to 24-months)
|
|
Reproductive system and breast disorders
Reproductive system problems
|
0.49%
1/204 • Number of events 1 • Primary and secondary outcome period (up to 24-months)
|
0.98%
2/205 • Number of events 2 • Primary and secondary outcome period (up to 24-months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory problem
|
4.4%
9/204 • Number of events 10 • Primary and secondary outcome period (up to 24-months)
|
2.4%
5/205 • Number of events 7 • Primary and secondary outcome period (up to 24-months)
|
|
Skin and subcutaneous tissue disorders
Skin problems
|
2.9%
6/204 • Number of events 6 • Primary and secondary outcome period (up to 24-months)
|
3.9%
8/205 • Number of events 8 • Primary and secondary outcome period (up to 24-months)
|
|
Vascular disorders
Vascular problems
|
0.00%
0/204 • Primary and secondary outcome period (up to 24-months)
|
0.49%
1/205 • Number of events 1 • Primary and secondary outcome period (up to 24-months)
|
Additional Information
Nan Lv, PhD, Research Scientist
Univeristy of Illinois, Chicago
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place