Trial Outcomes & Findings for Peer Navigators to Address Obesity-Related Concerns for African Americans With Serious Mental Illness (NCT NCT03382782)
NCT ID: NCT03382782
Last Updated: 2023-12-08
Results Overview
Change in Weight (pounds/lbs)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
234 participants
Primary outcome timeframe
0, 4, 8 and 12 months
Results posted on
2023-12-08
Participant Flow
213 participants were assigned to an arm/group.
Participant milestones
| Measure |
Behavioral Weight Loss Intervention
Participants will enroll in the BWLI program for 12 months. BWLI consists of a 8-month initial intervention phase followed by 4-month maintenance phase. The initial intervention phase comprises four types of contact:
* 1-hour to 1-hour, 30 minute group weight-management class led by facilitator (once per week; 26 classes followed by a one week break and an additional 8 weight management review classes)
* 45 minute, physical activity led by facilitator (one-two times per week);
* 20 minute, monthly individual visit with facilitator to address barriers to goals and appropriate skills; and
* weigh-in during weight management group and individual visits (once each week).
BWLI: BWLI includes group weight management classes, physical activity classes, individual sessions with a facilitator to address goals and barriers to weight loss, and weigh-ins.
|
BWLI & Peer Navigator
Participants randomly assigned to this condition will begin simultaneously with BWLI and run concurrently across the eight months of the intervention. Peer navigators will meet individually and face-to-face with research participants in time and places convenient to the person as needed. Specific practices are determined by the research participant with the peer navigator and may include:
* partnering with participant on BWLI homework;
* meeting with participant and BWLI facilitator individually;
* attending all other health care appointments; and
* partnering on tasks that arise out of those appointments.
BWLI \& Peer Navigator: Participants receive the BWLI condition and partner with a peer navigator. Peer navigators will meet individually and face-to-face with participants to address their health and weight goals (i.e. working on BWLI homework, attending health care appointments, and facilitating diet and exercise activities).
|
Integrated Care (Treatment as Usual)
Participants in this arm will receive integrated care from their usual provider, which is treatment as usual. Integrated care is mental health specialty and general medical care providers working together to address the physical and behavioral health care needs of patients. One-third of research participants will be randomized to integrated care alone.
Integrated Care: Participants receive integrated physical and mental health care from their usual provider.
|
|---|---|---|---|
|
Cohort 1
STARTED
|
41
|
35
|
30
|
|
Cohort 1
COMPLETED
|
30
|
30
|
30
|
|
Cohort 1
NOT COMPLETED
|
11
|
5
|
0
|
|
Cohort 2
STARTED
|
24
|
28
|
27
|
|
Cohort 2
COMPLETED
|
23
|
27
|
27
|
|
Cohort 2
NOT COMPLETED
|
1
|
1
|
0
|
|
Cohort 3
STARTED
|
17
|
19
|
13
|
|
Cohort 3
COMPLETED
|
16
|
17
|
13
|
|
Cohort 3
NOT COMPLETED
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
Behavioral Weight Loss Intervention
Participants will enroll in the BWLI program for 12 months. BWLI consists of a 8-month initial intervention phase followed by 4-month maintenance phase. The initial intervention phase comprises four types of contact:
* 1-hour to 1-hour, 30 minute group weight-management class led by facilitator (once per week; 26 classes followed by a one week break and an additional 8 weight management review classes)
* 45 minute, physical activity led by facilitator (one-two times per week);
* 20 minute, monthly individual visit with facilitator to address barriers to goals and appropriate skills; and
* weigh-in during weight management group and individual visits (once each week).
BWLI: BWLI includes group weight management classes, physical activity classes, individual sessions with a facilitator to address goals and barriers to weight loss, and weigh-ins.
|
BWLI & Peer Navigator
Participants randomly assigned to this condition will begin simultaneously with BWLI and run concurrently across the eight months of the intervention. Peer navigators will meet individually and face-to-face with research participants in time and places convenient to the person as needed. Specific practices are determined by the research participant with the peer navigator and may include:
* partnering with participant on BWLI homework;
* meeting with participant and BWLI facilitator individually;
* attending all other health care appointments; and
* partnering on tasks that arise out of those appointments.
BWLI \& Peer Navigator: Participants receive the BWLI condition and partner with a peer navigator. Peer navigators will meet individually and face-to-face with participants to address their health and weight goals (i.e. working on BWLI homework, attending health care appointments, and facilitating diet and exercise activities).
|
Integrated Care (Treatment as Usual)
Participants in this arm will receive integrated care from their usual provider, which is treatment as usual. Integrated care is mental health specialty and general medical care providers working together to address the physical and behavioral health care needs of patients. One-third of research participants will be randomized to integrated care alone.
Integrated Care: Participants receive integrated physical and mental health care from their usual provider.
|
|---|---|---|---|
|
Cohort 1
Withdrawal by Subject
|
11
|
5
|
0
|
|
Cohort 2
Withdrawal by Subject
|
1
|
1
|
0
|
|
Cohort 3
Withdrawal by Subject
|
1
|
2
|
0
|
Baseline Characteristics
Peer Navigators to Address Obesity-Related Concerns for African Americans With Serious Mental Illness
Baseline characteristics by cohort
| Measure |
Behavioral Weight Loss Intervention
n=69 Participants
Participants will enroll in the BWLI program for 12 months. BWLI consists of a 8-month initial intervention phase followed by 4-month maintenance phase. The initial intervention phase comprises four types of contact:
* 1-hour to 1-hour, 30 minute group weight-management class led by facilitator (once per week; 26 classes followed by a one week break and an additional 8 weight management review classes)
* 45 minute, physical activity led by facilitator (one-two times per week);
* 20 minute, monthly individual visit with facilitator to address barriers to goals and appropriate skills; and
* weigh-in during weight management group and individual visits (once each week).
|
BWLI & Peer Navigator
n=74 Participants
Participants randomly assigned to this condition will begin simultaneously with BWLI and run concurrently across the eight months of the intervention. Peer navigators will meet individually and face-to-face with research participants in time and places convenient to the person as needed. Specific practices are determined by the research participant with the peer navigator and may include:
* partnering with participant on BWLI homework;
* meeting with participant and BWLI facilitator individually;
* attending all other health care appointments; and
* partnering on tasks that arise out of those appointments.
|
Integrated Care (Treatment as Usual)
n=70 Participants
Participants in this arm will receive integrated care from their usual provider, which is treatment as usual. Integrated care is mental health specialty and general medical care providers working together to address the physical and behavioral health care needs of patients. One-third of research participants will be randomized to integrated care alone.
Integrated Care: Participants receive integrated physical and mental health care from their usual provider.
|
Total
n=213 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
66 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
203 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Age, Continuous
|
49.93 years
STANDARD_DEVIATION 10.48 • n=5 Participants
|
52.91 years
STANDARD_DEVIATION 8.81 • n=7 Participants
|
51.37 years
STANDARD_DEVIATION 8.55 • n=5 Participants
|
51.4 years
STANDARD_DEVIATION 9.30 • n=4 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
9 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
1 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American
|
69 participants
n=5 Participants
|
74 participants
n=7 Participants
|
70 participants
n=5 Participants
|
213 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
69 participants
n=5 Participants
|
74 participants
n=7 Participants
|
70 participants
n=5 Participants
|
213 participants
n=4 Participants
|
|
SF-36 Subscale: General Health
|
60.20 units on a scale
STANDARD_DEVIATION 23.05 • n=5 Participants
|
58.00 units on a scale
STANDARD_DEVIATION 22.11 • n=7 Participants
|
59.13 units on a scale
STANDARD_DEVIATION 22.66 • n=5 Participants
|
58.59 units on a scale
STANDARD_DEVIATION 22.72 • n=4 Participants
|
|
SF-36 Subscale: Bodily Pain
|
59.87 units on a scale
STANDARD_DEVIATION 26.25 • n=5 Participants
|
61.94 units on a scale
STANDARD_DEVIATION 28.91 • n=7 Participants
|
59.96 units on a scale
STANDARD_DEVIATION 27.31 • n=5 Participants
|
61.15 units on a scale
STANDARD_DEVIATION 26.90 • n=4 Participants
|
|
SF-36 Subscale: Physical Functioning
|
63.86 units on a scale
STANDARD_DEVIATION 25.07 • n=5 Participants
|
67.00 units on a scale
STANDARD_DEVIATION 26.51 • n=7 Participants
|
69.23 units on a scale
STANDARD_DEVIATION 22.20 • n=5 Participants
|
66.02 units on a scale
STANDARD_DEVIATION 25.69 • n=4 Participants
|
|
SF-36 Subscale: Emotional Well-Being
|
63.58 units on a scale
STANDARD_DEVIATION 20.57 • n=5 Participants
|
60.43 units on a scale
STANDARD_DEVIATION 21.17 • n=7 Participants
|
63.43 units on a scale
STANDARD_DEVIATION 23.53 • n=5 Participants
|
62.40 units on a scale
STANDARD_DEVIATION 21.53 • n=4 Participants
|
|
CES-D (Depression)
|
23.79 units on a scale
STANDARD_DEVIATION 11.87 • n=5 Participants
|
23.67 units on a scale
STANDARD_DEVIATION 10.97 • n=7 Participants
|
21.93 units on a scale
STANDARD_DEVIATION 11.25 • n=5 Participants
|
23.15 units on a scale
STANDARD_DEVIATION 11.24 • n=4 Participants
|
|
RAS-R (Recovery)
|
95.73 units on a scale
STANDARD_DEVIATION 13.81 • n=5 Participants
|
95.32 units on a scale
STANDARD_DEVIATION 12.44 • n=7 Participants
|
98.21 units on a scale
STANDARD_DEVIATION 11.96 • n=5 Participants
|
96.24 units on a scale
STANDARD_DEVIATION 12.61 • n=4 Participants
|
|
QLS (Quality of Life)
|
27.61 units on a scale
STANDARD_DEVIATION 8.12 • n=5 Participants
|
27.00 units on a scale
STANDARD_DEVIATION 6.78 • n=7 Participants
|
27.58 units on a scale
STANDARD_DEVIATION 6.91 • n=5 Participants
|
27.20 units on a scale
STANDARD_DEVIATION 7.35 • n=4 Participants
|
|
WEL (Weight Efficacy Lifestyle)
|
102.83 units on a scale
STANDARD_DEVIATION 38.32 • n=5 Participants
|
99.22 units on a scale
STANDARD_DEVIATION 31.48 • n=7 Participants
|
99.26 units on a scale
STANDARD_DEVIATION 32.35 • n=5 Participants
|
99.99 units on a scale
STANDARD_DEVIATION 33.69 • n=4 Participants
|
|
EES (Emotional Eating)
|
42.14 units on a scale
STANDARD_DEVIATION 23.25 • n=5 Participants
|
43.14 units on a scale
STANDARD_DEVIATION 21.15 • n=7 Participants
|
40.90 units on a scale
STANDARD_DEVIATION 21.15 • n=5 Participants
|
43.00 units on a scale
STANDARD_DEVIATION 21.52 • n=4 Participants
|
|
Healthy Lifestyle Behaviors Total
|
34.82 units on a scale
STANDARD_DEVIATION 8.03 • n=5 Participants
|
34.51 units on a scale
STANDARD_DEVIATION 6.56 • n=7 Participants
|
35.16 units on a scale
STANDARD_DEVIATION 7.85 • n=5 Participants
|
34.70 units on a scale
STANDARD_DEVIATION 7.30 • n=4 Participants
|
|
Healthy Lifestyle Behaviors: Physical Activity Subscale
|
14.86 units on a scale
STANDARD_DEVIATION 4.16 • n=5 Participants
|
14.38 units on a scale
STANDARD_DEVIATION 3.78 • n=7 Participants
|
14.38 units on a scale
STANDARD_DEVIATION 4.06 • n=5 Participants
|
14.54 units on a scale
STANDARD_DEVIATION 4.00 • n=4 Participants
|
|
Healthy Lifestyle Behaviors: Diet Subscale
|
18.12 units on a scale
STANDARD_DEVIATION 4.78 • n=5 Participants
|
18.20 units on a scale
STANDARD_DEVIATION 4.56 • n=7 Participants
|
18.54 units on a scale
STANDARD_DEVIATION 4.87 • n=5 Participants
|
18.29 units on a scale
STANDARD_DEVIATION 4.74 • n=4 Participants
|
PRIMARY outcome
Timeframe: 0, 4, 8 and 12 monthsPopulation: Data collection for Weight variable was challenging (COVID, transition to online) and ultimately discontinued after Cohort 1. The results and intent-to-treat analyses for Weight are based on data from subset of participants before Weight data collection ceased.
Change in Weight (pounds/lbs)
Outcome measures
| Measure |
Behavioral Weight Loss Intervention
n=31 Participants
Participants will enroll in the BWLI program for 12 months. BWLI consists of a 8-month initial intervention phase followed by 4-month maintenance phase. The initial intervention phase comprises four types of contact:
* 1-hour to 1-hour, 30 minute group weight-management class led by facilitator (once per week; 26 classes followed by a one week break and an additional 8 weight management review classes)
* 45 minute, physical activity led by facilitator (one-two times per week);
* 20 minute, monthly individual visit with facilitator to address barriers to goals and appropriate skills; and
* weigh-in during weight management group and individual visits (once each week).
|
BWLI & Peer Navigator
n=28 Participants
Participants randomly assigned to this condition will begin simultaneously with BWLI and run concurrently across the eight months of the intervention. Peer navigators will meet individually and face-to-face with research participants in time and places convenient to the person as needed. Specific practices are determined by the research participant with the peer navigator and may include:
* partnering with participant on BWLI homework;
* meeting with participant and BWLI facilitator individually;
* attending all other health care appointments; and
* partnering on tasks that arise out of those appointments.
|
Integrated Care (Treatment as Usual)
n=31 Participants
Participants in this arm will receive integrated care from their usual provider, which is treatment as usual. Integrated care is mental health specialty and general medical care providers working together to address the physical and behavioral health care needs of patients. One-third of research participants will be randomized to integrated care alone.
Integrated Care: Participants receive integrated physical and mental health care from their usual provider.
|
|---|---|---|---|
|
Weight
Baseline
|
226.54 pounds (lbs)
Standard Deviation 41.22
|
225.46 pounds (lbs)
Standard Deviation 52.94
|
218.19 pounds (lbs)
Standard Deviation 40.41
|
|
Weight
4-Month
|
225.63 pounds (lbs)
Standard Deviation 42.58
|
223.21 pounds (lbs)
Standard Deviation 51.27
|
214.85 pounds (lbs)
Standard Deviation 40.99
|
|
Weight
8-Month
|
227.66 pounds (lbs)
Standard Deviation 42.12
|
223.25 pounds (lbs)
Standard Deviation 50.63
|
216.03 pounds (lbs)
Standard Deviation 39.62
|
|
Weight
12-Month
|
228.86 pounds (lbs)
Standard Deviation 41.29
|
222.41 pounds (lbs)
Standard Deviation 50.13
|
216.65 pounds (lbs)
Standard Deviation 39.54
|
SECONDARY outcome
Timeframe: 0, 8 monthsPopulation: Analysis was performed on "intention-to-treat." Participants were categorized based on research condition assigned at baseline regardless of BHL or PHN attendance.
Quality of Life Scale. Assesses life domains including general life, daily activities, and social contact. 6-items assessing how participants feel about different aspects of their lives including as a whole, accomplishments, how they handle problems, family, and activities (1=Terrible, 7=Delighted). Range from 0 to 126. Higher scores indicate better outcome (better quality of life).
Outcome measures
| Measure |
Behavioral Weight Loss Intervention
n=69 Participants
Participants will enroll in the BWLI program for 12 months. BWLI consists of a 8-month initial intervention phase followed by 4-month maintenance phase. The initial intervention phase comprises four types of contact:
* 1-hour to 1-hour, 30 minute group weight-management class led by facilitator (once per week; 26 classes followed by a one week break and an additional 8 weight management review classes)
* 45 minute, physical activity led by facilitator (one-two times per week);
* 20 minute, monthly individual visit with facilitator to address barriers to goals and appropriate skills; and
* weigh-in during weight management group and individual visits (once each week).
|
BWLI & Peer Navigator
n=74 Participants
Participants randomly assigned to this condition will begin simultaneously with BWLI and run concurrently across the eight months of the intervention. Peer navigators will meet individually and face-to-face with research participants in time and places convenient to the person as needed. Specific practices are determined by the research participant with the peer navigator and may include:
* partnering with participant on BWLI homework;
* meeting with participant and BWLI facilitator individually;
* attending all other health care appointments; and
* partnering on tasks that arise out of those appointments.
|
Integrated Care (Treatment as Usual)
n=70 Participants
Participants in this arm will receive integrated care from their usual provider, which is treatment as usual. Integrated care is mental health specialty and general medical care providers working together to address the physical and behavioral health care needs of patients. One-third of research participants will be randomized to integrated care alone.
Integrated Care: Participants receive integrated physical and mental health care from their usual provider.
|
|---|---|---|---|
|
Quality of Life Scale (QLS)
Baseline
|
27.61 score on a scale
Standard Deviation 8.12
|
27.00 score on a scale
Standard Deviation 6.78
|
27.58 score on a scale
Standard Deviation 6.91
|
|
Quality of Life Scale (QLS)
8-Month
|
28.63 score on a scale
Standard Deviation 7.69
|
28.53 score on a scale
Standard Deviation 6.83
|
29.49 score on a scale
Standard Deviation 6.84
|
SECONDARY outcome
Timeframe: 0, 8 monthsPopulation: Analysis was performed on "intention-to-treat." Participants were categorized based on research condition assigned at baseline regardless of BHL or PHN attendance.
Based on Original Recovery Assessment Scale. RAS-Revised is shorter 24 item scale with individual items representing aspects of recovery to which participants respond on a 5-point agreement scale (1=strongly disagree, 5=strongly agree).There are five factors (1) personal confidence and hope; (2) willingness to ask for help; (3) goal and success orientation; (4) reliance on others; (5) not dominated by symptoms. Range from 24-120. Higher scores indicate better outcome (better recovery).
Outcome measures
| Measure |
Behavioral Weight Loss Intervention
n=69 Participants
Participants will enroll in the BWLI program for 12 months. BWLI consists of a 8-month initial intervention phase followed by 4-month maintenance phase. The initial intervention phase comprises four types of contact:
* 1-hour to 1-hour, 30 minute group weight-management class led by facilitator (once per week; 26 classes followed by a one week break and an additional 8 weight management review classes)
* 45 minute, physical activity led by facilitator (one-two times per week);
* 20 minute, monthly individual visit with facilitator to address barriers to goals and appropriate skills; and
* weigh-in during weight management group and individual visits (once each week).
|
BWLI & Peer Navigator
n=74 Participants
Participants randomly assigned to this condition will begin simultaneously with BWLI and run concurrently across the eight months of the intervention. Peer navigators will meet individually and face-to-face with research participants in time and places convenient to the person as needed. Specific practices are determined by the research participant with the peer navigator and may include:
* partnering with participant on BWLI homework;
* meeting with participant and BWLI facilitator individually;
* attending all other health care appointments; and
* partnering on tasks that arise out of those appointments.
|
Integrated Care (Treatment as Usual)
n=70 Participants
Participants in this arm will receive integrated care from their usual provider, which is treatment as usual. Integrated care is mental health specialty and general medical care providers working together to address the physical and behavioral health care needs of patients. One-third of research participants will be randomized to integrated care alone.
Integrated Care: Participants receive integrated physical and mental health care from their usual provider.
|
|---|---|---|---|
|
Recovery Assessment Scale-Revised (RAS-R)
Baseline
|
95.73 score on a scale
Standard Deviation 13.81
|
95.32 score on a scale
Standard Deviation 12.44
|
98.21 score on a scale
Standard Deviation 11.96
|
|
Recovery Assessment Scale-Revised (RAS-R)
8-Month
|
98.72 score on a scale
Standard Deviation 14.33
|
98.85 score on a scale
Standard Deviation 13.01
|
97.65 score on a scale
Standard Deviation 13.92
|
SECONDARY outcome
Timeframe: 0, 8 monthsPopulation: Analysis was performed on "intention-to-treat." Participants were categorized based on research condition assigned at baseline regardless of BHL or PHN attendance.
Weight Efficacy Lifestyle Questionnaire. 20 items. Assesses participant confidence in resisting eating in some typical eating situations. Items rated on scale from 0=Not confident at all to 9=Very confident. Scores range from 0 to 180. Higher scores indicate better outcome (greater eating self-efficacy).
Outcome measures
| Measure |
Behavioral Weight Loss Intervention
n=69 Participants
Participants will enroll in the BWLI program for 12 months. BWLI consists of a 8-month initial intervention phase followed by 4-month maintenance phase. The initial intervention phase comprises four types of contact:
* 1-hour to 1-hour, 30 minute group weight-management class led by facilitator (once per week; 26 classes followed by a one week break and an additional 8 weight management review classes)
* 45 minute, physical activity led by facilitator (one-two times per week);
* 20 minute, monthly individual visit with facilitator to address barriers to goals and appropriate skills; and
* weigh-in during weight management group and individual visits (once each week).
|
BWLI & Peer Navigator
n=74 Participants
Participants randomly assigned to this condition will begin simultaneously with BWLI and run concurrently across the eight months of the intervention. Peer navigators will meet individually and face-to-face with research participants in time and places convenient to the person as needed. Specific practices are determined by the research participant with the peer navigator and may include:
* partnering with participant on BWLI homework;
* meeting with participant and BWLI facilitator individually;
* attending all other health care appointments; and
* partnering on tasks that arise out of those appointments.
|
Integrated Care (Treatment as Usual)
n=70 Participants
Participants in this arm will receive integrated care from their usual provider, which is treatment as usual. Integrated care is mental health specialty and general medical care providers working together to address the physical and behavioral health care needs of patients. One-third of research participants will be randomized to integrated care alone.
Integrated Care: Participants receive integrated physical and mental health care from their usual provider.
|
|---|---|---|---|
|
Weight Efficacy Lifetime (WEL) Questionnaire
Baseline
|
102.83 score on a scale
Standard Deviation 38.32
|
99.22 score on a scale
Standard Deviation 31.48
|
99.26 score on a scale
Standard Deviation 32.35
|
|
Weight Efficacy Lifetime (WEL) Questionnaire
8-Month
|
124.72 score on a scale
Standard Deviation 33.81
|
116.13 score on a scale
Standard Deviation 32.40
|
109.93 score on a scale
Standard Deviation 39.06
|
SECONDARY outcome
Timeframe: 0, 8 monthsPopulation: Due to COVID-19, interviews were transitioned online to be conducted virtually. In order to minimize participant fatigue, secondary outcome measures including this Self-Efficacy for Exercise Scale were discontinued. The 8 Month values refer to subset of participants who completed 8 Month interview before the Self-Efficacy for Exercise Scale was discontinued.
Assesses participant beliefs in their ability to continue exercising on a three-time per week basis at moderate intensities. Range from 0 to 90. Higher score = better.
Outcome measures
| Measure |
Behavioral Weight Loss Intervention
n=62 Participants
Participants will enroll in the BWLI program for 12 months. BWLI consists of a 8-month initial intervention phase followed by 4-month maintenance phase. The initial intervention phase comprises four types of contact:
* 1-hour to 1-hour, 30 minute group weight-management class led by facilitator (once per week; 26 classes followed by a one week break and an additional 8 weight management review classes)
* 45 minute, physical activity led by facilitator (one-two times per week);
* 20 minute, monthly individual visit with facilitator to address barriers to goals and appropriate skills; and
* weigh-in during weight management group and individual visits (once each week).
|
BWLI & Peer Navigator
n=64 Participants
Participants randomly assigned to this condition will begin simultaneously with BWLI and run concurrently across the eight months of the intervention. Peer navigators will meet individually and face-to-face with research participants in time and places convenient to the person as needed. Specific practices are determined by the research participant with the peer navigator and may include:
* partnering with participant on BWLI homework;
* meeting with participant and BWLI facilitator individually;
* attending all other health care appointments; and
* partnering on tasks that arise out of those appointments.
|
Integrated Care (Treatment as Usual)
n=64 Participants
Participants in this arm will receive integrated care from their usual provider, which is treatment as usual. Integrated care is mental health specialty and general medical care providers working together to address the physical and behavioral health care needs of patients. One-third of research participants will be randomized to integrated care alone.
Integrated Care: Participants receive integrated physical and mental health care from their usual provider.
|
|---|---|---|---|
|
Self-Efficacy for Exercise Scale
0 Month
|
74.05 score on a scale
Standard Deviation 24.50
|
69.02 score on a scale
Standard Deviation 23.88
|
76.56 score on a scale
Standard Deviation 22.70
|
|
Self-Efficacy for Exercise Scale
8 Month
|
66.34 score on a scale
Standard Deviation 24.28
|
62.10 score on a scale
Standard Deviation 25.62
|
67.15 score on a scale
Standard Deviation 23.82
|
SECONDARY outcome
Timeframe: 0, 4, 8, 12 monthsPopulation: Data collection for Waist Circumference variable was challenging (COVID, transition to online) and ultimately discontinued after Cohort 1. The results and intent-to-treat analyses for Waist Circumference are based on data from subset of participants before Waist Circumference data collection ceased.
Change in waist circumference
Outcome measures
| Measure |
Behavioral Weight Loss Intervention
n=31 Participants
Participants will enroll in the BWLI program for 12 months. BWLI consists of a 8-month initial intervention phase followed by 4-month maintenance phase. The initial intervention phase comprises four types of contact:
* 1-hour to 1-hour, 30 minute group weight-management class led by facilitator (once per week; 26 classes followed by a one week break and an additional 8 weight management review classes)
* 45 minute, physical activity led by facilitator (one-two times per week);
* 20 minute, monthly individual visit with facilitator to address barriers to goals and appropriate skills; and
* weigh-in during weight management group and individual visits (once each week).
|
BWLI & Peer Navigator
n=28 Participants
Participants randomly assigned to this condition will begin simultaneously with BWLI and run concurrently across the eight months of the intervention. Peer navigators will meet individually and face-to-face with research participants in time and places convenient to the person as needed. Specific practices are determined by the research participant with the peer navigator and may include:
* partnering with participant on BWLI homework;
* meeting with participant and BWLI facilitator individually;
* attending all other health care appointments; and
* partnering on tasks that arise out of those appointments.
|
Integrated Care (Treatment as Usual)
n=31 Participants
Participants in this arm will receive integrated care from their usual provider, which is treatment as usual. Integrated care is mental health specialty and general medical care providers working together to address the physical and behavioral health care needs of patients. One-third of research participants will be randomized to integrated care alone.
Integrated Care: Participants receive integrated physical and mental health care from their usual provider.
|
|---|---|---|---|
|
Waist Circumference
0 Months (Baseline)
|
46.00 inches
Standard Deviation 4.54
|
43.85 inches
Standard Deviation 6.18
|
44.99 inches
Standard Deviation 5.61
|
|
Waist Circumference
4 Months
|
45.56 inches
Standard Deviation 4.90
|
44.78 inches
Standard Deviation 6.90
|
44.60 inches
Standard Deviation 6.34
|
|
Waist Circumference
8 Months
|
46.23 inches
Standard Deviation 4.69
|
44.36 inches
Standard Deviation 6.44
|
43.82 inches
Standard Deviation 6.16
|
|
Waist Circumference
12 Months
|
45.98 inches
Standard Deviation 5.04
|
44.13 inches
Standard Deviation 6.58
|
43.99 inches
Standard Deviation 5.59
|
SECONDARY outcome
Timeframe: 0, 4, 8, 12 monthsPopulation: Data collection for Blood Pressure variable was challenging (COVID, transition to online) and ultimately discontinued after Cohort 1. The results and intent-to-treat analyses for Blood Pressure are based on data from subset of participants before Blood Pressure data collection ceased.
Mean diastolic and systolic blood pressure (BP), in millimeters of mercury (mmHg) across 4 time frames.
Outcome measures
| Measure |
Behavioral Weight Loss Intervention
n=27 Participants
Participants will enroll in the BWLI program for 12 months. BWLI consists of a 8-month initial intervention phase followed by 4-month maintenance phase. The initial intervention phase comprises four types of contact:
* 1-hour to 1-hour, 30 minute group weight-management class led by facilitator (once per week; 26 classes followed by a one week break and an additional 8 weight management review classes)
* 45 minute, physical activity led by facilitator (one-two times per week);
* 20 minute, monthly individual visit with facilitator to address barriers to goals and appropriate skills; and
* weigh-in during weight management group and individual visits (once each week).
|
BWLI & Peer Navigator
n=25 Participants
Participants randomly assigned to this condition will begin simultaneously with BWLI and run concurrently across the eight months of the intervention. Peer navigators will meet individually and face-to-face with research participants in time and places convenient to the person as needed. Specific practices are determined by the research participant with the peer navigator and may include:
* partnering with participant on BWLI homework;
* meeting with participant and BWLI facilitator individually;
* attending all other health care appointments; and
* partnering on tasks that arise out of those appointments.
|
Integrated Care (Treatment as Usual)
n=30 Participants
Participants in this arm will receive integrated care from their usual provider, which is treatment as usual. Integrated care is mental health specialty and general medical care providers working together to address the physical and behavioral health care needs of patients. One-third of research participants will be randomized to integrated care alone.
Integrated Care: Participants receive integrated physical and mental health care from their usual provider.
|
|---|---|---|---|
|
Blood Pressure
0 Month (Baseline) Mean systolic BP
|
127.39 millimeters of mercury (mmHg)
Standard Deviation 15.52
|
124.98 millimeters of mercury (mmHg)
Standard Deviation 25.97
|
126.85 millimeters of mercury (mmHg)
Standard Deviation 25.79
|
|
Blood Pressure
0 Month (Baseline) Mean diastolic BP
|
89.11 millimeters of mercury (mmHg)
Standard Deviation 13.12
|
92.10 millimeters of mercury (mmHg)
Standard Deviation 12.55
|
90.27 millimeters of mercury (mmHg)
Standard Deviation 14.23
|
|
Blood Pressure
4 Month Mean systolic BP
|
129.35 millimeters of mercury (mmHg)
Standard Deviation 18.34
|
129.12 millimeters of mercury (mmHg)
Standard Deviation 25.78
|
125.93 millimeters of mercury (mmHg)
Standard Deviation 15.99
|
|
Blood Pressure
4 Month Mean diastolic BP
|
87.22 millimeters of mercury (mmHg)
Standard Deviation 14.13
|
86.62 millimeters of mercury (mmHg)
Standard Deviation 14.54
|
84.50 millimeters of mercury (mmHg)
Standard Deviation 10.06
|
|
Blood Pressure
8 Month Mean systolic BP
|
132.83 millimeters of mercury (mmHg)
Standard Deviation 21.30
|
124.80 millimeters of mercury (mmHg)
Standard Deviation 21.18
|
125.43 millimeters of mercury (mmHg)
Standard Deviation 18.22
|
|
Blood Pressure
8 Month Mean diastolic BP
|
86.87 millimeters of mercury (mmHg)
Standard Deviation 13.79
|
83.20 millimeters of mercury (mmHg)
Standard Deviation 12.31
|
85.63 millimeters of mercury (mmHg)
Standard Deviation 13.16
|
|
Blood Pressure
12 Month Mean systolic BP
|
130.06 millimeters of mercury (mmHg)
Standard Deviation 19.89
|
133.68 millimeters of mercury (mmHg)
Standard Deviation 24.34
|
130.95 millimeters of mercury (mmHg)
Standard Deviation 14.02
|
|
Blood Pressure
12 Month Mean diastolic BP
|
86.70 millimeters of mercury (mmHg)
Standard Deviation 13.25
|
87.46 millimeters of mercury (mmHg)
Standard Deviation 12.06
|
86.52 millimeters of mercury (mmHg)
Standard Deviation 9.26
|
SECONDARY outcome
Timeframe: 0 Month (Baseline)Population: Physical measurement only collected once (at Baseline)
Measure participants' height (inches)
Outcome measures
| Measure |
Behavioral Weight Loss Intervention
n=69 Participants
Participants will enroll in the BWLI program for 12 months. BWLI consists of a 8-month initial intervention phase followed by 4-month maintenance phase. The initial intervention phase comprises four types of contact:
* 1-hour to 1-hour, 30 minute group weight-management class led by facilitator (once per week; 26 classes followed by a one week break and an additional 8 weight management review classes)
* 45 minute, physical activity led by facilitator (one-two times per week);
* 20 minute, monthly individual visit with facilitator to address barriers to goals and appropriate skills; and
* weigh-in during weight management group and individual visits (once each week).
|
BWLI & Peer Navigator
n=70 Participants
Participants randomly assigned to this condition will begin simultaneously with BWLI and run concurrently across the eight months of the intervention. Peer navigators will meet individually and face-to-face with research participants in time and places convenient to the person as needed. Specific practices are determined by the research participant with the peer navigator and may include:
* partnering with participant on BWLI homework;
* meeting with participant and BWLI facilitator individually;
* attending all other health care appointments; and
* partnering on tasks that arise out of those appointments.
|
Integrated Care (Treatment as Usual)
n=74 Participants
Participants in this arm will receive integrated care from their usual provider, which is treatment as usual. Integrated care is mental health specialty and general medical care providers working together to address the physical and behavioral health care needs of patients. One-third of research participants will be randomized to integrated care alone.
Integrated Care: Participants receive integrated physical and mental health care from their usual provider.
|
|---|---|---|---|
|
Height
|
65.38 inches
Standard Deviation 3.65
|
66.68 inches
Standard Deviation 3.85
|
66.29 inches
Standard Deviation 4.70
|
SECONDARY outcome
Timeframe: 0, 8 monthsPopulation: Analysis was performed on "intention-to-treat." Participants were categorized based on research condition assigned at baseline regardless of BHL or PHN attendance.
36-Item Short Form Health Survey. Assess change in participants' health status and health related quality of life. Includes 4 subscales: (1) General health, (2) bodily pain, (3) physical functioning, (4) emotional well-being; range from 0-100 for each subscale. Higher score indicates better outcome.
Outcome measures
| Measure |
Behavioral Weight Loss Intervention
n=69 Participants
Participants will enroll in the BWLI program for 12 months. BWLI consists of a 8-month initial intervention phase followed by 4-month maintenance phase. The initial intervention phase comprises four types of contact:
* 1-hour to 1-hour, 30 minute group weight-management class led by facilitator (once per week; 26 classes followed by a one week break and an additional 8 weight management review classes)
* 45 minute, physical activity led by facilitator (one-two times per week);
* 20 minute, monthly individual visit with facilitator to address barriers to goals and appropriate skills; and
* weigh-in during weight management group and individual visits (once each week).
|
BWLI & Peer Navigator
n=74 Participants
Participants randomly assigned to this condition will begin simultaneously with BWLI and run concurrently across the eight months of the intervention. Peer navigators will meet individually and face-to-face with research participants in time and places convenient to the person as needed. Specific practices are determined by the research participant with the peer navigator and may include:
* partnering with participant on BWLI homework;
* meeting with participant and BWLI facilitator individually;
* attending all other health care appointments; and
* partnering on tasks that arise out of those appointments.
|
Integrated Care (Treatment as Usual)
n=70 Participants
Participants in this arm will receive integrated care from their usual provider, which is treatment as usual. Integrated care is mental health specialty and general medical care providers working together to address the physical and behavioral health care needs of patients. One-third of research participants will be randomized to integrated care alone.
Integrated Care: Participants receive integrated physical and mental health care from their usual provider.
|
|---|---|---|---|
|
36-Item Short Form Health Survey (SF-36)
0 Month-General Health Subscale (Baseline)
|
60.20 score on a scale
Standard Deviation 23.05
|
58.00 score on a scale
Standard Deviation 22.11
|
59.13 score on a scale
Standard Deviation 22.66
|
|
36-Item Short Form Health Survey (SF-36)
0 Month-Bodily Pain Subscale (Baseline)
|
59.87 score on a scale
Standard Deviation 26.25
|
61.94 score on a scale
Standard Deviation 28.91
|
59.96 score on a scale
Standard Deviation 27.31
|
|
36-Item Short Form Health Survey (SF-36)
0 Month-Physical Functioning Subscale (Baseline)
|
63.86 score on a scale
Standard Deviation 25.07
|
67.00 score on a scale
Standard Deviation 26.51
|
69.23 score on a scale
Standard Deviation 22.20
|
|
36-Item Short Form Health Survey (SF-36)
0 Month-Emotional Well-Being Subscale (Baseline)
|
63.58 score on a scale
Standard Deviation 20.57
|
60.43 score on a scale
Standard Deviation 21.17
|
63.43 score on a scale
Standard Deviation 23.53
|
|
36-Item Short Form Health Survey (SF-36)
8 Month-General Health Subscale
|
62.11 score on a scale
Standard Deviation 20.53
|
64.23 score on a scale
Standard Deviation 21.96
|
58.17 score on a scale
Standard Deviation 24.92
|
|
36-Item Short Form Health Survey (SF-36)
8 Month-Bodily Pain Subscale
|
58.11 score on a scale
Standard Deviation 27.13
|
63.25 score on a scale
Standard Deviation 29.94
|
59.52 score on a scale
Standard Deviation 26.29
|
|
36-Item Short Form Health Survey (SF-36)
8 Month-Physical Functioning Subscale
|
59.74 score on a scale
Standard Deviation 27.72
|
68.54 score on a scale
Standard Deviation 27.23
|
60.48 score on a scale
Standard Deviation 28.12
|
|
36-Item Short Form Health Survey (SF-36)
8 Month-Emotional Well-Being Subscale
|
64.49 score on a scale
Standard Deviation 20.70
|
67.20 score on a scale
Standard Deviation 18.27
|
68.32 score on a scale
Standard Deviation 18.86
|
SECONDARY outcome
Timeframe: 0, 8 monthsAssess change in participants' experienced symptoms associated with depression. 10 items. Range from 0-60. Higher score indicates worse outcome (greater depressive symptoms).
Outcome measures
| Measure |
Behavioral Weight Loss Intervention
n=69 Participants
Participants will enroll in the BWLI program for 12 months. BWLI consists of a 8-month initial intervention phase followed by 4-month maintenance phase. The initial intervention phase comprises four types of contact:
* 1-hour to 1-hour, 30 minute group weight-management class led by facilitator (once per week; 26 classes followed by a one week break and an additional 8 weight management review classes)
* 45 minute, physical activity led by facilitator (one-two times per week);
* 20 minute, monthly individual visit with facilitator to address barriers to goals and appropriate skills; and
* weigh-in during weight management group and individual visits (once each week).
|
BWLI & Peer Navigator
n=74 Participants
Participants randomly assigned to this condition will begin simultaneously with BWLI and run concurrently across the eight months of the intervention. Peer navigators will meet individually and face-to-face with research participants in time and places convenient to the person as needed. Specific practices are determined by the research participant with the peer navigator and may include:
* partnering with participant on BWLI homework;
* meeting with participant and BWLI facilitator individually;
* attending all other health care appointments; and
* partnering on tasks that arise out of those appointments.
|
Integrated Care (Treatment as Usual)
n=70 Participants
Participants in this arm will receive integrated care from their usual provider, which is treatment as usual. Integrated care is mental health specialty and general medical care providers working together to address the physical and behavioral health care needs of patients. One-third of research participants will be randomized to integrated care alone.
Integrated Care: Participants receive integrated physical and mental health care from their usual provider.
|
|---|---|---|---|
|
Center for Epidemiologic Studies Depression Scale-Depression(CES-D)
Baseline
|
23.79 score on a scale
Standard Deviation 11.87
|
23.67 score on a scale
Standard Deviation 10.97
|
21.93 score on a scale
Standard Deviation 11.25
|
|
Center for Epidemiologic Studies Depression Scale-Depression(CES-D)
8-Month
|
21.04 score on a scale
Standard Deviation 12.93
|
20.53 score on a scale
Standard Deviation 12.09
|
20.07 score on a scale
Standard Deviation 11.22
|
SECONDARY outcome
Timeframe: 0 monthsPopulation: Due to COVID-19, interviews were transitioned online to be conducted virtually. In order to minimize participant fatigue, secondary outcome measures including this Evidence-Based Practices Use (EBPU) were discontinued.
Assess change in participants' enrollment in clinical and service interventions. Range from 0-10, higher scores = better outcome.
Outcome measures
| Measure |
Behavioral Weight Loss Intervention
n=68 Participants
Participants will enroll in the BWLI program for 12 months. BWLI consists of a 8-month initial intervention phase followed by 4-month maintenance phase. The initial intervention phase comprises four types of contact:
* 1-hour to 1-hour, 30 minute group weight-management class led by facilitator (once per week; 26 classes followed by a one week break and an additional 8 weight management review classes)
* 45 minute, physical activity led by facilitator (one-two times per week);
* 20 minute, monthly individual visit with facilitator to address barriers to goals and appropriate skills; and
* weigh-in during weight management group and individual visits (once each week).
|
BWLI & Peer Navigator
n=73 Participants
Participants randomly assigned to this condition will begin simultaneously with BWLI and run concurrently across the eight months of the intervention. Peer navigators will meet individually and face-to-face with research participants in time and places convenient to the person as needed. Specific practices are determined by the research participant with the peer navigator and may include:
* partnering with participant on BWLI homework;
* meeting with participant and BWLI facilitator individually;
* attending all other health care appointments; and
* partnering on tasks that arise out of those appointments.
|
Integrated Care (Treatment as Usual)
n=70 Participants
Participants in this arm will receive integrated care from their usual provider, which is treatment as usual. Integrated care is mental health specialty and general medical care providers working together to address the physical and behavioral health care needs of patients. One-third of research participants will be randomized to integrated care alone.
Integrated Care: Participants receive integrated physical and mental health care from their usual provider.
|
|---|---|---|---|
|
Evidence-Based Practices Use (EBPU)
|
4.07 score on a scale
Standard Deviation 2.46
|
4.21 score on a scale
Standard Deviation 2.65
|
4.09 score on a scale
Standard Deviation 2.48
|
SECONDARY outcome
Timeframe: 0, 8 monthsAssess change in participants' experienced negative emotions and their relationships with desire to eat. 25 items. (0=No desire to eat, 5=Overwhelming urge to eat). Comprised of 3 subscales, added together for a total score. Range from 0 to 125. Higher scores indicate worse outcome (stronger desire to eat).
Outcome measures
| Measure |
Behavioral Weight Loss Intervention
n=69 Participants
Participants will enroll in the BWLI program for 12 months. BWLI consists of a 8-month initial intervention phase followed by 4-month maintenance phase. The initial intervention phase comprises four types of contact:
* 1-hour to 1-hour, 30 minute group weight-management class led by facilitator (once per week; 26 classes followed by a one week break and an additional 8 weight management review classes)
* 45 minute, physical activity led by facilitator (one-two times per week);
* 20 minute, monthly individual visit with facilitator to address barriers to goals and appropriate skills; and
* weigh-in during weight management group and individual visits (once each week).
|
BWLI & Peer Navigator
n=74 Participants
Participants randomly assigned to this condition will begin simultaneously with BWLI and run concurrently across the eight months of the intervention. Peer navigators will meet individually and face-to-face with research participants in time and places convenient to the person as needed. Specific practices are determined by the research participant with the peer navigator and may include:
* partnering with participant on BWLI homework;
* meeting with participant and BWLI facilitator individually;
* attending all other health care appointments; and
* partnering on tasks that arise out of those appointments.
|
Integrated Care (Treatment as Usual)
n=70 Participants
Participants in this arm will receive integrated care from their usual provider, which is treatment as usual. Integrated care is mental health specialty and general medical care providers working together to address the physical and behavioral health care needs of patients. One-third of research participants will be randomized to integrated care alone.
Integrated Care: Participants receive integrated physical and mental health care from their usual provider.
|
|---|---|---|---|
|
Emotional Eating Scale (EES)
Baseline
|
42.14 score on a scale
Standard Deviation 23.25
|
43.14 score on a scale
Standard Deviation 21.15
|
40.90 score on a scale
Standard Deviation 21.15
|
|
Emotional Eating Scale (EES)
8-Month
|
35.60 score on a scale
Standard Deviation 20.58
|
33.63 score on a scale
Standard Deviation 21.26
|
36.61 score on a scale
Standard Deviation 21.38
|
SECONDARY outcome
Timeframe: BaselinePopulation: Due to COVID-19, interviews were transitioned online to be conducted virtually. In order to minimize participant fatigue, secondary outcome measures, including this Life Events Checklist for DSM-5 was discontinued. Overall number of participants analyzed refers to those who completed the measure before it was discontinued. Number of participants analyzed in each row endorsed history of that trauma type. There was not enough data collected for further analysis.
Life Events Checklist (LEC) for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Assess participants experiences of potential traumatic events on a 6-point nominal scale, across 16 types of traumatic events. No formal scoring protocol or interpretation recommended. Reported scores indicate average amount of distress by traumatic event type. Higher values indicate greater distress from exposure to trauma = worse outcomes (Minimum = 0, maximum = 7).
Outcome measures
| Measure |
Behavioral Weight Loss Intervention
n=68 Participants
Participants will enroll in the BWLI program for 12 months. BWLI consists of a 8-month initial intervention phase followed by 4-month maintenance phase. The initial intervention phase comprises four types of contact:
* 1-hour to 1-hour, 30 minute group weight-management class led by facilitator (once per week; 26 classes followed by a one week break and an additional 8 weight management review classes)
* 45 minute, physical activity led by facilitator (one-two times per week);
* 20 minute, monthly individual visit with facilitator to address barriers to goals and appropriate skills; and
* weigh-in during weight management group and individual visits (once each week).
|
BWLI & Peer Navigator
n=73 Participants
Participants randomly assigned to this condition will begin simultaneously with BWLI and run concurrently across the eight months of the intervention. Peer navigators will meet individually and face-to-face with research participants in time and places convenient to the person as needed. Specific practices are determined by the research participant with the peer navigator and may include:
* partnering with participant on BWLI homework;
* meeting with participant and BWLI facilitator individually;
* attending all other health care appointments; and
* partnering on tasks that arise out of those appointments.
|
Integrated Care (Treatment as Usual)
n=70 Participants
Participants in this arm will receive integrated care from their usual provider, which is treatment as usual. Integrated care is mental health specialty and general medical care providers working together to address the physical and behavioral health care needs of patients. One-third of research participants will be randomized to integrated care alone.
Integrated Care: Participants receive integrated physical and mental health care from their usual provider.
|
|---|---|---|---|
|
Life Events Checklist for DSM-5
Natural Disaster
|
4.08 score on a scale
Standard Deviation 2.53
|
3.71 score on a scale
Standard Deviation 2.05
|
2.94 score on a scale
Standard Deviation 2.21
|
|
Life Events Checklist for DSM-5
Fire or Explosion
|
3.86 score on a scale
Standard Deviation 2.21
|
3.52 score on a scale
Standard Deviation 2.48
|
3.09 score on a scale
Standard Deviation 2.37
|
|
Life Events Checklist for DSM-5
Transportation Accident
|
4.28 score on a scale
Standard Deviation 1.90
|
3.84 score on a scale
Standard Deviation 2.49
|
3.09 score on a scale
Standard Deviation 2.25
|
|
Life Events Checklist for DSM-5
Serious Accident at Work/Home/Recreational
|
4.06 score on a scale
Standard Deviation 1.53
|
4.67 score on a scale
Standard Deviation 2.54
|
5.36 score on a scale
Standard Deviation 1.43
|
|
Life Events Checklist for DSM-5
Exposure to Toxic Substance
|
4.00 score on a scale
Standard Deviation 2.97
|
4.88 score on a scale
Standard Deviation 2.64
|
5.00 score on a scale
Standard Deviation 1.89
|
|
Life Events Checklist for DSM-5
Physical Assault Without a Weapon
|
4.96 score on a scale
Standard Deviation 1.97
|
4.66 score on a scale
Standard Deviation 2.43
|
4.24 score on a scale
Standard Deviation 2.31
|
|
Life Events Checklist for DSM-5
Assault With a Weapon
|
4.82 score on a scale
Standard Deviation 1.97
|
5.04 score on a scale
Standard Deviation 2.29
|
3.81 score on a scale
Standard Deviation 2.35
|
|
Life Events Checklist for DSM-5
Sexual Assault
|
5.82 score on a scale
Standard Deviation 1.68
|
5.60 score on a scale
Standard Deviation 2.31
|
4.73 score on a scale
Standard Deviation 2.27
|
|
Life Events Checklist for DSM-5
Other Unwanted or Uncomfortable Sexual Experience
|
5.12 score on a scale
Standard Deviation 1.50
|
5.05 score on a scale
Standard Deviation 2.46
|
5.08 score on a scale
Standard Deviation 2.47
|
|
Life Events Checklist for DSM-5
Combat
|
2.80 score on a scale
Standard Deviation 1.30
|
4.00 score on a scale
Standard Deviation 4.24
|
3.30 score on a scale
Standard Deviation 2.41
|
|
Life Events Checklist for DSM-5
Captivity
|
5.62 score on a scale
Standard Deviation 2.07
|
5.33 score on a scale
Standard Deviation 1.51
|
6.00 score on a scale
Standard Deviation 1.31
|
|
Life Events Checklist for DSM-5
Life-threatening Illness or Injury
|
5.00 score on a scale
Standard Deviation 1.80
|
4.63 score on a scale
Standard Deviation 2.36
|
4.38 score on a scale
Standard Deviation 2.33
|
|
Life Events Checklist for DSM-5
Severe Human Suffering
|
5.41 score on a scale
Standard Deviation 1.42
|
5.14 score on a scale
Standard Deviation 2.32
|
5.57 score on a scale
Standard Deviation 1.79
|
|
Life Events Checklist for DSM-5
Serious Injury, Harm, or Death Caused
|
5.67 score on a scale
Standard Deviation 1.21
|
3.56 score on a scale
Standard Deviation 2.83
|
6.11 score on a scale
Standard Deviation 1.36
|
|
Life Events Checklist for DSM-5
Incarceration
|
4.52 score on a scale
Standard Deviation 2.15
|
3.86 score on a scale
Standard Deviation 2.70
|
4.15 score on a scale
Standard Deviation 2.49
|
|
Life Events Checklist for DSM-5
Homelessness
|
4.60 score on a scale
Standard Deviation 2.16
|
5.06 score on a scale
Standard Deviation 2.59
|
4.75 score on a scale
Standard Deviation 2.34
|
|
Life Events Checklist for DSM-5
Involuntary Hospitalization
|
4.26 score on a scale
Standard Deviation 2.33
|
3.94 score on a scale
Standard Deviation 2.72
|
4.65 score on a scale
Standard Deviation 2.18
|
|
Life Events Checklist for DSM-5
Exposure to Neighborhood Violence
|
4.61 score on a scale
Standard Deviation 2.31
|
4.45 score on a scale
Standard Deviation 2.34
|
4.97 score on a scale
Standard Deviation 2.00
|
|
Life Events Checklist for DSM-5
Any Other Very Stressful Event
|
6.67 score on a scale
Standard Deviation 0.52
|
6.27 score on a scale
Standard Deviation 1.27
|
5.71 score on a scale
Standard Deviation 1.38
|
Adverse Events
Behavioral Weight Loss Intervention
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
BWLI & Peer Navigator
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Integrated Care (Treatment as Usual)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Behavioral Weight Loss Intervention
n=69 participants at risk
Participants will enroll in the BWLI program for 12 months. BWLI consists of a 8-month initial intervention phase followed by 4-month maintenance phase. The initial intervention phase comprises four types of contact:
* 1-hour to 1-hour, 30 minute group weight-management class led by facilitator (once per week; 26 classes followed by a one week break and an additional 8 weight management review classes)
* 45 minute, physical activity led by facilitator (one-two times per week);
* 20 minute, monthly individual visit with facilitator to address barriers to goals and appropriate skills; and
* weigh-in during weight management group and individual visits (once each week).
|
BWLI & Peer Navigator
n=74 participants at risk
Participants randomly assigned to this condition will begin simultaneously with BWLI and run concurrently across the eight months of the intervention. Peer navigators will meet individually and face-to-face with research participants in time and places convenient to the person as needed. Specific practices are determined by the research participant with the peer navigator and may include:
* partnering with participant on BWLI homework;
* meeting with participant and BWLI facilitator individually;
* attending all other health care appointments; and
* partnering on tasks that arise out of those appointments.
|
Integrated Care (Treatment as Usual)
n=70 participants at risk
Participants in this arm will receive integrated care from their usual provider, which is treatment as usual. Integrated care is mental health specialty and general medical care providers working together to address the physical and behavioral health care needs of patients. One-third of research participants will be randomized to integrated care alone.
Integrated Care: Participants receive integrated physical and mental health care from their usual provider.
|
|---|---|---|---|
|
General disorders
High blood pressure observed at interview
|
0.00%
0/69 • 2 years, 11 months
Adverse Event: Any unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporarily associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research. Severe Adverse Event: Event severity determined by scale, 1 is an adverse event of minimal severity, and 4 is an adverse event of maximal severity:
|
1.4%
1/74 • Number of events 1 • 2 years, 11 months
Adverse Event: Any unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporarily associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research. Severe Adverse Event: Event severity determined by scale, 1 is an adverse event of minimal severity, and 4 is an adverse event of maximal severity:
|
0.00%
0/70 • 2 years, 11 months
Adverse Event: Any unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporarily associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research. Severe Adverse Event: Event severity determined by scale, 1 is an adverse event of minimal severity, and 4 is an adverse event of maximal severity:
|
|
General disorders
Difficulty walking to interview, back pain
|
1.4%
1/69 • Number of events 1 • 2 years, 11 months
Adverse Event: Any unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporarily associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research. Severe Adverse Event: Event severity determined by scale, 1 is an adverse event of minimal severity, and 4 is an adverse event of maximal severity:
|
0.00%
0/74 • 2 years, 11 months
Adverse Event: Any unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporarily associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research. Severe Adverse Event: Event severity determined by scale, 1 is an adverse event of minimal severity, and 4 is an adverse event of maximal severity:
|
0.00%
0/70 • 2 years, 11 months
Adverse Event: Any unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporarily associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research. Severe Adverse Event: Event severity determined by scale, 1 is an adverse event of minimal severity, and 4 is an adverse event of maximal severity:
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Lindsay Sheehan, Co-Investigator
Illinois Institute of Technology
Phone: 312-567-7983
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place