Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1U01MD010541 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
| ACCESS Community Health Network | OTHER |
| Trilogy Inc. Behavioral Healthcare | OTHER |
Not provided
Not provided
Not provided
Not provided
People with serious mental illness such as schizophrenia and bipolar disorder experience high rates of physical illness and die earlier than people without serious mental illness (WHO, 2005). Health differences seem to be worse among African Americans (Weber, Cowan, Millikan & Niebuhr, 2009). High rates of obesity among this group contribute to health and wellness concerns (de Hert et al., 2011), with African American women at higher risk of obesity than men. Behavioral weight loss interventions (BWLIs) may promote diet and physical activity that lead to weight loss, but healthy food and safe physical activity options are less available in low-income neighborhoods. Peer navigators have been found to be effective in addressing health differences, and may help people living in low-income communities find healthy food and activity resources (Fischer, Sauaia, & Kutner, 2007). In addition, traumatic experiences are common among persons with serious mental illness as well as African Americans, and may impact weight.
Through this project, investigators will test two interventions designed to address overweight and obesity among African Americans with serious mental illness. The first is a BWLI designed for persons with serious mental illness and adapted to meet the needs of African Americans. This program has 8-month intervention phase and 4-month maintenance phase. The intervention includes group weight management classes, group physical activity, individual visits to address barriers to meeting weight goals, and weigh-ins. The second intervention is a peer navigator program that assists people with serious mental illness in meeting their health needs in the community. Two-hundred and seventy (270) research participants will be recruited and randomly assigned to one of three conditions: BWLI program, BWLI program plus peer navigator, and treatment as usual (integrated physical and mental health care). Investigators will evaluate these interventions over a 12-month period, and will track weight change, health behaviors, physical and mental health, recovery, and quality of life. Investigators also seek to understand the impact of gender and trauma on outcomes. Investigators hypothesize that peer navigators will improve outcomes over the BWLI program alone. Findings will advance knowledge and services to reduce racial disparities in obesity and comorbid health conditions for African Americans with serious mental illnesses.
Persons with serious mental illness experience disproportionate rates of physical health morbidity and mortality (WHO, 2005). One reason is a metabolic syndrome marked by significant obesity which seems even worse for African Americans. Although research suggests behavioral weight loss interventions (BWLIs) may promote healthy lifestyle behaviors (diet and exercise) that leads to weight loss, these programs are hindered by several social determinants of health found in low-income communities with food and activity deserts that undermine program goals. Preliminary evidence finds that peer navigators (service providers in recovery from serious mental illness) can help people to better avail existing healthcare programs, thereby improving health. Based on this evidence, our community-based participatory research (CBPR) project develops and tests two existing interventions to address the weight concerns of African Americans with serious mental illness:
As compared with men, African American women with serious mental illness are at an even higher risk for lifetime prevalence of obesity (Baskaran et al., 2014; Galletly et al., 2012). Through an administrative supplement, investigators have augmented the approach of our study to understand the role of gender on the attainment of weight goals, with a specific focus on trauma, an experience of particular importance to women's health.
Two-hundred and seventy (270) African Americans with serious mental illness who are overweight or obese will be randomized to one of three conditions after baseline assessments: integrated physical and mental health care, integrated physical and mental health care plus BWLI, or integrated physical and mental health care plus BWLI and peer navigator (PN).
The BWLI has a 8-month intervention phase followed by a 4-month maintenance phase. The intervention includes group weight management classes, physical activity, individual visits to address barriers to meeting goals and to develop skills, and weigh-ins. PNs will partner with participants on BWLI assignments, meet with participants and BWLI facilitators, or accompany participants to health care appointments and follow-up. In addition, PNs and participants will team up to assess community diet and activity resources, and based on this review, will develop strategies to address their diet and physical activity needs.
Investigators seek 70 participants per condition (N=210) to reach statistical power goals. Investigators will recruit 270 participants to account for expected loss-to-followup. Investigators will enroll participants in discrete cohorts every nine months.
Investigators will analyze fidelity, process, outcome and impact data, including the effect of BWLI and BWLI and PN on weight, waist circumference, blood pressure, health behavior, physical and mental health, recovery and quality of life. Measures will be repeated at 4, 8, and 12 months. To understand the impact of gender, investigators will stratify the sample on gender at recruitment and analyze all program outcome measures by gender. To better understand the impact of trauma, investigators will determine if trauma exposure moderates the effect of the study intervention. Investigators will also conduct post-hoc analyses to determine if gender matching between PNs and participants (e.g., female-female and male-male) led to better effects.
Investigators' main hypothesis is that the BWLI and PN condition will lead to greater weight loss and enhanced health behaviors compared with the two other conditions. Findings will advance knowledge and services to reduce racial disparities in obesity and comorbid health conditions for African Americans with serious mental illnesses.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Weight Loss Intervention | Active Comparator | 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:
|
|
| BWLI & Peer Navigator | Experimental | 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:
|
|
| Integrated Care (Treatment as Usual) | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BWLI | Behavioral | 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. A punch card system will be implemented to incentivize participation for BHL classes. Each participant from the BWLI condition will be given a punch card, each punch card contains 10 spaces of punches, and will receive a punch at the end of each class (either BHL or physical activity) they attend. No punch will be given if they are more than 15 minutes late for BHL class or more than 5 minutes late for physical activity class. Participants can earn $5 per punch for up to $250. They will be allowed to cash in for $50 Visa gift card every 10 punches. They cannot cash in for a partially filled card. They must have the 10 full punches to cash in. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Change in Weight (pounds/lbs) | 0, 4, 8 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Scale (QLS) | 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Participants must identify as female or male.
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Patrick Corrigan, PsyD | Illinois Institute of Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Illinois Institute of Technology | Chicago | Illinois | 60616 | United States | ||
| Trilogy Behavioral Healthcare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24467470 | Background | Baskaran A, Cha DS, Powell AM, Jalil D, McIntyre RS. Sex differences in rates of obesity in bipolar disorder: postulated mechanisms. Bipolar Disord. 2014 Feb;16(1):83-92. doi: 10.1111/bdi.12141. Epub 2013 Oct 29. | |
| 28093056 | Background | Corrigan PW, Kraus DJ, Pickett SA, Schmidt A, Stellon E, Hantke E, Lara JL. Using Peer Navigators to Address the Integrated Health Care Needs of Homeless African Americans With Serious Mental Illness. Psychiatr Serv. 2017 Mar 1;68(3):264-270. doi: 10.1176/appi.ps.201600134. Epub 2017 Jan 17. |
| Label | URL |
|---|---|
| World Health Organization, 2005. Information Sheet: Premature Death Among People with Mental Illness. | View source |
Not provided
Results will be available to researchers and service agencies, with quantitative data available from an expected 210 African American participants with serious mental illness who report concerns obesity or being overweight. No identifying information will be connected to the data and investigators do not believe that there is a possibility of deductive disclosure of subjects with unusual characteristics. Regardless, to ensure the protection of the human subjects involved in this research, investigators will make the data and associated documentation available to users only under a data-sharing agreement. Notice of available data will be posted in appropriate arenas including websites for the project: www.chicagohealthdisparities.org and www.ncse1.org.
Not provided
Data will be available on 12-31-2020.
To ensure the protection of the human subjects involved in our research, investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
213 participants were assigned to an arm/group.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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:
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. |
| FG001 | 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:
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). |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cohort 1 |
|
| ||||||||||||||||||
| Cohort 2 |
| |||||||||||||||||||
| Cohort 3 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight | Change in Weight (pounds/lbs) | 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. | Posted | Mean | Standard Deviation | pounds (lbs) | 0, 4, 8 and 12 months |
|
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:
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High blood pressure observed at interview | General disorders | OHRP | Systematic Assessment | Participant's blood pressure was observed to be very high during data collection (1st reading: 160+/109) (2nd reading: 150+/109). Research interviewer notified medical team at clinic. Caseworker waited until transfer to hospital for evaluation. |
Not provided
Difficulties with study retention led to missing data, which limited power and options for data analysis. COVID-19 challenges forced a change to online format, impacting standardization of delivery across cohorts.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lindsay Sheehan, Co-Investigator | Illinois Institute of Technology | 312-567-7983 | lsheehan@iit.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 29, 2018 | May 29, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 29, 2018 | May 29, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D001523 | Mental Disorders |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
| ID | Term |
|---|---|
| D019033 | Delivery of Health Care, Integrated |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
The behavioral weight loss intervention (BWLI) consists of an 8-month intervention phase followed by a 4-month maintenance phase. The initial intervention phase comprises four types of contact: 1) One-hour to one and a half hour group weight management class led by facilitator (once per week); 2) 45-minute physical activity class led by facilitator (1-2 per week); 3) 20-minute, individual visit with facilitator (once per month); 4) Weigh-in (once each week). Persons are randomly assigned to peer navigators to begin simultaneously with BWLI and run concurrently across the eight months of the intervention. PNs may work with participants to partner on BWLI homework, meet with participant and BWLI facilitator individually, attend health care appointments, and partner on tasks that arise out of those appointments.
Not provided
Not provided
Not provided
Not provided
|
|
| BWLI & Peer Navigator | Behavioral | 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). A punch card system will be implemented to incentivize participation for BHL classes. Each participant from BWLI & Peer Navigator will be given a punch card, each punch card contains 10 spaces of punches, and will receive a punch at the end of each class (either BHL or physical activity) they attend. No punch will be given if they are more than 15 minutes late for BHL class or more than 5 minutes late for physical activity class. Participants can earn $5 per punch for up to $250. They will be allowed to cash in for $50 Visa gift card every 10 punches. They cannot cash in for a partially filled card. They must have the 10 full punches to cash in. |
|
| Integrated Care | Behavioral | Participants receive integrated physical and mental health care from their usual provider. |
|
| 0, 8 months |
| Recovery Assessment Scale-Revised (RAS-R) | 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). | 0, 8 months |
| Weight Efficacy Lifetime (WEL) Questionnaire | 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). | 0, 8 months |
| Self-Efficacy for Exercise Scale | 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. | 0, 8 months |
| Waist Circumference | Change in waist circumference | 0, 4, 8, 12 months |
| Blood Pressure | Mean diastolic and systolic blood pressure (BP), in millimeters of mercury (mmHg) across 4 time frames. | 0, 4, 8, 12 months |
| Height | Measure participants' height (inches) | 0 Month (Baseline) |
| 36-Item Short Form Health Survey (SF-36) | 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. | 0, 8 months |
| Center for Epidemiologic Studies Depression Scale-Depression(CES-D) | Assess change in participants' experienced symptoms associated with depression. 10 items. Range from 0-60. Higher score indicates worse outcome (greater depressive symptoms). | 0, 8 months |
| Evidence-Based Practices Use (EBPU) | Assess change in participants' enrollment in clinical and service interventions. Range from 0-10, higher scores = better outcome. | 0 months |
| Emotional Eating Scale (EES) | Assess 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). | 0, 8 months |
| Life Events Checklist for DSM-5 | 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). | Baseline |
| Chicago |
| Illinois |
| 60626 |
| United States |
| Access Community Health Network | Chicago | Illinois | 60661 | United States |
| 21379357 | Background | DE Hert M, Correll CU, Bobes J, Cetkovich-Bakmas M, Cohen D, Asai I, Detraux J, Gautam S, Moller HJ, Ndetei DM, Newcomer JW, Uwakwe R, Leucht S. Physical illness in patients with severe mental disorders. I. Prevalence, impact of medications and disparities in health care. World Psychiatry. 2011 Feb;10(1):52-77. doi: 10.1002/j.2051-5545.2011.tb00014.x. |
| 17985954 | Background | Fischer SM, Sauaia A, Kutner JS. Patient navigation: a culturally competent strategy to address disparities in palliative care. J Palliat Med. 2007 Oct;10(5):1023-8. doi: 10.1089/jpm.2007.0070. No abstract available. |
| 23584716 | Background | Goldberg RW, Reeves G, Tapscott S, Medoff D, Dickerson F, Goldberg AP, Ryan AS, Fang LJ, Dixon LB. "MOVE!" Outcomes of a weight loss program modified for veterans with serious mental illness. Psychiatr Serv. 2013 Aug 1;64(8):737-44. doi: 10.1176/appi.ps.201200314. |
| 19648193 | Background | Weber NS, Cowan DN, Millikan AM, Niebuhr DW. Psychiatric and general medical conditions comorbid with schizophrenia in the National Hospital Discharge Survey. Psychiatr Serv. 2009 Aug;60(8):1059-67. doi: 10.1176/ps.2009.60.8.1059. |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| BG001 | 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:
|
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Identifying as African American was inclusion criteria. Race/Ethnicity listed refers only to participants who identified as any other Race/Ethnicity, in addition to African American. Thus, total percentage is less than 100. | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| SF-36 Subscale: General Health | From 36-Item Short Form Health Survey. Assess change in participants' health status and health related quality of life. General Health is one of four measure subscales. General Health subscale includes 5 items. Range from 0-100. Higher score indicates better outcome (better health status). | Mean | Standard Deviation | units on a scale |
|
| SF-36 Subscale: Bodily Pain | From 36-Item Short From Health Survey. Assess change in participants' health status and health related quality of life. Bodily Pain is one of four measure subscales. Bodily Pain subscale includes 2 items. Range from 0-100. Higher score indicates better outcomes (better health status, less pain). | Mean | Standard Deviation | units on a scale |
|
| SF-36 Subscale: Physical Functioning | From 36-Item Short From Health Survey. Assess change in participants' health status and health related quality of life. Physical Functioning is one of four measure subscales. Physical Functioning subscale includes 10 items. Range from 0-100. Higher score indicates better outcome (better health status, less physically limited). | Mean | Standard Deviation | units on a scale |
|
| SF-36 Subscale: Emotional Well-Being | From 36-Item Short From Health Survey. Assess change in participants' health status and health related quality of life. Emotional Well-Being is one of four measure subscales. Emotional Well-Being subscale includes 5 items. Range from 0-100. Higher score indicates better outcome (better health status, less limited by emotional issues). | Mean | Standard Deviation | units on a scale |
|
| CES-D (Depression) | Center for Epidemiological Studies Depression Scale. 10 items. Assess change in participants' experienced symptoms of depression. Range from 0 to 60. Higher scores indicate worse outcome (greater depressive symptoms). | Mean | Standard Deviation | units on a scale |
|
| RAS-R (Recovery) | 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). Range from 24-120. Higher scores indicate better outcome (better recovery). | Mean | Standard Deviation | units on a scale |
|
| QLS (Quality of Life) | Quality of Life Scale. 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). | Mean | Standard Deviation | units on a scale |
|
| WEL (Weight Efficacy Lifestyle) | 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). | Mean | Standard Deviation | units on a scale |
|
| EES (Emotional Eating) | Emotional Eating Scale. Assess 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). | Mean | Standard Deviation | units on a scale |
|
| Healthy Lifestyle Behaviors Total | Healthy Lifestyle Behaviors. Assess diet and physical activity. 12 items related to diet, physical activity, and receiving support. Responses from 1=Not at all, never to 5=Most of the time, nearly every day. 12 items totaled for one overall score. Range from 0 to 60. Higher scores indicate better outcome (greater frequency of healthy behaviors). | Mean | Standard Deviation | units on a scale |
|
| Healthy Lifestyle Behaviors: Physical Activity Subscale | Physical Activity subscale of Healthy Lifestyle Behaviors. 5 items (1=Not at all, never; 5=Most of the time, nearly every day). Range from 5 to 25. Higher score indicates better outcome (greater physical activity). | Mean | Standard Deviation | units on a scale |
|
| Healthy Lifestyle Behaviors: Diet Subscale | Diet subscale of Healthy Lifestyle Behaviors. 6 items (1=Not at all, never; 5=Most of the time, nearly every day). Range from 6 to 30. Higher scores indicate better outcome (greater frequency of healthy diet behaviors). | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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:
|
| OG002 | 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. |
|
|
|
| Secondary | Quality of Life Scale (QLS) | 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). | Analysis was performed on "intention-to-treat." Participants were categorized based on research condition assigned at baseline regardless of BHL or PHN attendance. | Posted | Mean | Standard Deviation | score on a scale | 0, 8 months |
|
|
|
|
| Secondary | Recovery Assessment Scale-Revised (RAS-R) | 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). | Analysis was performed on "intention-to-treat." Participants were categorized based on research condition assigned at baseline regardless of BHL or PHN attendance. | Posted | Mean | Standard Deviation | score on a scale | 0, 8 months |
|
|
|
|
| Secondary | Weight Efficacy Lifetime (WEL) Questionnaire | 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). | Analysis was performed on "intention-to-treat." Participants were categorized based on research condition assigned at baseline regardless of BHL or PHN attendance. | Posted | Mean | Standard Deviation | score on a scale | 0, 8 months |
|
|
|
|
| Secondary | Self-Efficacy for Exercise Scale | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 0, 8 months |
|
|
|
| Secondary | Waist Circumference | Change in waist circumference | 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. | Posted | Mean | Standard Deviation | inches | 0, 4, 8, 12 months |
|
|
|
|
| Secondary | Blood Pressure | Mean diastolic and systolic blood pressure (BP), in millimeters of mercury (mmHg) across 4 time frames. | 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. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | 0, 4, 8, 12 months |
|
|
|
|
| Secondary | Height | Measure participants' height (inches) | Physical measurement only collected once (at Baseline) | Posted | Mean | Standard Deviation | inches | 0 Month (Baseline) |
|
|
|
| Secondary | 36-Item Short Form Health Survey (SF-36) | 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. | Analysis was performed on "intention-to-treat." Participants were categorized based on research condition assigned at baseline regardless of BHL or PHN attendance. | Posted | Mean | Standard Deviation | score on a scale | 0, 8 months |
|
|
|
|
| Secondary | Center for Epidemiologic Studies Depression Scale-Depression(CES-D) | Assess change in participants' experienced symptoms associated with depression. 10 items. Range from 0-60. Higher score indicates worse outcome (greater depressive symptoms). | Posted | Mean | Standard Deviation | score on a scale | 0, 8 months |
|
|
|
|
| Secondary | Evidence-Based Practices Use (EBPU) | Assess change in participants' enrollment in clinical and service interventions. Range from 0-10, higher scores = better outcome. | 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. | Posted | Mean | Standard Deviation | score on a scale | 0 months |
|
|
|
| Secondary | Emotional Eating Scale (EES) | Assess 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). | Posted | Mean | Standard Deviation | score on a scale | 0, 8 months |
|
|
|
|
| Secondary | Life Events Checklist for DSM-5 | 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| 0 |
| 69 |
| 1 |
| 69 |
| 0 |
| 69 |
| EG001 | 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:
| 0 | 74 | 1 | 74 | 0 | 74 |
| EG002 | 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. | 0 | 70 | 0 | 70 | 0 | 70 |
|
| Difficulty walking to interview, back pain | General disorders | OHRP | Systematic Assessment | Researcher observed participant in hallway. Co-Investigator was consulted & present. 2 public safety officers assisted until participant was picked up by caseworker. |
|
Not provided
Not provided
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| ANOVA |
degrees of freedom = 1, 118 |
| 0.810 |
| Mean Difference (Net) |
| 0.058 |
| 2-Sided |
| Superiority |
|
| ANOVA |
degrees of freedom = 1, 118 |
| 0.286 |
| Mean Difference (Net) |
| 1.15 |
| 2-Sided |
| Superiority |
|
| ANOVA |
degrees of freedom = 1, 118 |
| 0.912 |
| Mean Difference (Net) |
| 0.012 |
| 2-Sided |
| Superiority |
| 8 Month |
|
|
|
| 8 Months |
|
| 12 Months |
|
|
| 4 Month Mean systolic BP |
|
| 4 Month Mean diastolic BP |
|
| 8 Month Mean systolic BP |
|
| 8 Month Mean diastolic BP |
|
| 12 Month Mean systolic BP |
|
| 12 Month Mean diastolic BP |
|
| ANOVA |
degrees of freedom = 3, 156 |
| 0.05 |
| Mean Difference (Net) |
| 0.63 |
| 2-Sided |
| Superiority |
|
| 0 Month-Physical Functioning Subscale (Baseline) |
|
| 0 Month-Emotional Well-Being Subscale (Baseline) |
|
| 8 Month-General Health Subscale |
|
| 8 Month-Bodily Pain Subscale |
|
| 8 Month-Physical Functioning Subscale |
|
| 8 Month-Emotional Well-Being Subscale |
|
As-treated analyses. General Health subscale.
| ANOVA |
degrees of freedom = 1, 118 |
| 0.193 |
| Mean Difference (Net) |
| 1.71 |
| 2-Sided |
| Superiority |
| Intention-to-treat analyses. Bodily Pain subscale. | ANOVA | degrees of freedom = 2, 182 | 0.835 | Mean Difference (Net) | 0.181 | 2-Sided | Superiority |
| As-treated analyses, Bodily Pain subscale. | ANOVA | degrees of freedom = 1, 118 | 0.513 | Mean Difference (Net) | 0.430 | 2-Sided | Superiority |
| Intention-to-treat analyses, Physical Functioning subscale. | ANOVA | degrees of freedom = 2, 182 | 0.097 | Mean Difference (Net) | 2.37 | 2-Sided | Superiority |
| As-treated analyses, Physical Functioning subscale. | ANOVA | degrees of freedom = 1, 118 | 0.184 | Mean Difference (Net) | 0.040 | 2-Sided | Superiority |
| Intention-to-treat analyses. Emotional Well-Being subscale. | ANOVA | degrees of freedom = 2, 182 | 0.347 | Mean Difference (Net) | 1.06 | 2-Sided | Superiority |
| As-treated analyses, Emotional Well-Being subscale. | ANOVA | degrees of freedom = 1, 118 | 0.549 | Mean Difference (Net) | 0.361 | 2-Sided | Superiority |
|
| ANOVA |
degrees of freedom = 1, 118 |
| 0.915 |
| Mean Difference (Net) |
| 0.011 |
| 2-Sided |
| Superiority |
|
| ANOVA |
degrees of freedom = 1, 118 |
| 0.198 |
| Mean Difference (Net) |
| 1.67 |
| 2-Sided |
| Superiority |
| Fire or Explosion |
|
|
| Transportation Accident |
|
|
| Serious Accident at Work/Home/Recreational |
|
|
| Exposure to Toxic Substance |
|
|
| Physical Assault Without a Weapon |
|
|
| Assault With a Weapon |
|
|
| Sexual Assault |
|
|
| Other Unwanted or Uncomfortable Sexual Experience |
|
|
| Combat |
|
|
| Captivity |
|
|
| Life-threatening Illness or Injury |
|
|
| Severe Human Suffering |
|
|
| Serious Injury, Harm, or Death Caused |
|
|
| Incarceration |
|
|
| Homelessness |
|
|
| Involuntary Hospitalization |
|
|
| Exposure to Neighborhood Violence |
|
|
| Any Other Very Stressful Event |
|
|