An interventional study of BWLI and BWLI & Peer Navigator in Obesity and Mental Disorder, sponsored by Illinois Institute of Technology. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-08.
Sponsored by Illinois Institute of Technology · Not applicable, Interventional, and Treatment
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 234 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Illinois Institute of Technology is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Behavioral: BWLI
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.
Behavioral: BWLI & Peer Navigator
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.
Behavioral: Integrated Care
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.
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.
Participants receive integrated physical and mental health care from their usual provider.
Weight
Change in Weight (pounds/lbs)
Time frame: 0, 4, 8 and 12 months
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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 0, 8 months
Waist Circumference
Change in waist circumference
Time frame: 0, 4, 8, 12 months
Blood Pressure
Mean diastolic and systolic blood pressure (BP), in millimeters of mercury (mmHg) across 4 time frames.
Time frame: 0, 4, 8, 12 months
Height
Measure participants' height (inches)
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Baseline
| Milestone | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) |
|---|---|---|---|
| Started | 41 | 35 | 30 |
| Completed | 30 | 30 | 30 |
| Not completed | 11 | 5 | 0 |
| Withdrew: Withdrawal by subject | 11 | 5 | 0 |
| Milestone | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) |
|---|---|---|---|
| Started | 24 | 28 | 27 |
| Completed | 23 | 27 | 27 |
| Not completed | 1 | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 | 0 |
| Milestone | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) |
|---|---|---|---|
| Started | 17 | 19 | 13 |
| Completed | 16 | 17 | 13 |
| Not completed | 1 | 2 | 0 |
| Withdrew: Withdrawal by subject | 1 | 2 | 0 |
Change in Weight (pounds/lbs)
| pounds (lbs) | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) |
|---|---|---|---|
| Baseline | 226.54 ± 41.22 | 225.46 ± 52.94 | 218.19 ± 40.41 |
| 4-Month | 225.63 ± 42.58 | 223.21 ± 51.27 | 214.85 ± 40.99 |
| 8-Month | 227.66 ± 42.12 | 223.25 ± 50.63 | 216.03 ± 39.62 |
| 12-Month | 228.86 ± 41.29 | 222.41 ± 50.13 | 216.65 ± 39.54 |
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).
| score on a scale | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) |
|---|---|---|---|
| Baseline | 27.61 ± 8.12 | 27.00 ± 6.78 | 27.58 ± 6.91 |
| 8-Month | 28.63 ± 7.69 | 28.53 ± 6.83 | 29.49 ± 6.84 |
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).
| score on a scale | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) |
|---|---|---|---|
| Baseline | 95.73 ± 13.81 | 95.32 ± 12.44 | 98.21 ± 11.96 |
| 8-Month | 98.72 ± 14.33 | 98.85 ± 13.01 | 97.65 ± 13.92 |
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).
| score on a scale | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) |
|---|---|---|---|
| Baseline | 102.83 ± 38.32 | 99.22 ± 31.48 | 99.26 ± 32.35 |
| 8-Month | 124.72 ± 33.81 | 116.13 ± 32.40 | 109.93 ± 39.06 |
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.
| score on a scale | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) |
|---|---|---|---|
| 0 Month | 74.05 ± 24.50 | 69.02 ± 23.88 | 76.56 ± 22.70 |
| 8 Month | 66.34 ± 24.28 | 62.10 ± 25.62 | 67.15 ± 23.82 |
Change in waist circumference
| inches | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) |
|---|---|---|---|
| 0 Months (Baseline) | 46.00 ± 4.54 | 43.85 ± 6.18 | 44.99 ± 5.61 |
| 4 Months | 45.56 ± 4.90 | 44.78 ± 6.90 | 44.60 ± 6.34 |
| 8 Months | 46.23 ± 4.69 | 44.36 ± 6.44 | 43.82 ± 6.16 |
| 12 Months | 45.98 ± 5.04 | 44.13 ± 6.58 | 43.99 ± 5.59 |
Mean diastolic and systolic blood pressure (BP), in millimeters of mercury (mmHg) across 4 time frames.
| millimeters of mercury (mmHg) | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) |
|---|---|---|---|
| 0 Month (Baseline) Mean systolic BP | 127.39 ± 15.52 | 124.98 ± 25.97 | 126.85 ± 25.79 |
| 0 Month (Baseline) Mean diastolic BP | 89.11 ± 13.12 | 92.10 ± 12.55 | 90.27 ± 14.23 |
| 4 Month Mean systolic BP | 129.35 ± 18.34 | 129.12 ± 25.78 | 125.93 ± 15.99 |
| 4 Month Mean diastolic BP | 87.22 ± 14.13 | 86.62 ± 14.54 | 84.50 ± 10.06 |
| 8 Month Mean systolic BP | 132.83 ± 21.30 | 124.80 ± 21.18 | 125.43 ± 18.22 |
| 8 Month Mean diastolic BP | 86.87 ± 13.79 | 83.20 ± 12.31 | 85.63 ± 13.16 |
| 12 Month Mean systolic BP | 130.06 ± 19.89 | 133.68 ± 24.34 | 130.95 ± 14.02 |
| 12 Month Mean diastolic BP | 86.70 ± 13.25 | 87.46 ± 12.06 | 86.52 ± 9.26 |
Measure participants' height (inches)
| inches | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) |
|---|---|---|---|
| Height | 65.38 ± 3.65 | 66.68 ± 3.85 | 66.29 ± 4.70 |
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.
| score on a scale | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) |
|---|---|---|---|
| 0 Month-General Health Subscale (Baseline) | 60.20 ± 23.05 | 58.00 ± 22.11 | 59.13 ± 22.66 |
| 0 Month-Bodily Pain Subscale (Baseline) | 59.87 ± 26.25 | 61.94 ± 28.91 | 59.96 ± 27.31 |
| 0 Month-Physical Functioning Subscale (Baseline) | 63.86 ± 25.07 | 67.00 ± 26.51 | 69.23 ± 22.20 |
| 0 Month-Emotional Well-Being Subscale (Baseline) | 63.58 ± 20.57 | 60.43 ± 21.17 | 63.43 ± 23.53 |
| 8 Month-General Health Subscale | 62.11 ± 20.53 | 64.23 ± 21.96 | 58.17 ± 24.92 |
| 8 Month-Bodily Pain Subscale | 58.11 ± 27.13 | 63.25 ± 29.94 | 59.52 ± 26.29 |
| 8 Month-Physical Functioning Subscale | 59.74 ± 27.72 | 68.54 ± 27.23 | 60.48 ± 28.12 |
| 8 Month-Emotional Well-Being Subscale | 64.49 ± 20.70 | 67.20 ± 18.27 | 68.32 ± 18.86 |
Assess change in participants' experienced symptoms associated with depression. 10 items. Range from 0-60. Higher score indicates worse outcome (greater depressive symptoms).
| score on a scale | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) |
|---|---|---|---|
| Baseline | 23.79 ± 11.87 | 23.67 ± 10.97 | 21.93 ± 11.25 |
| 8-Month | 21.04 ± 12.93 | 20.53 ± 12.09 | 20.07 ± 11.22 |
Assess change in participants' enrollment in clinical and service interventions. Range from 0-10, higher scores = better outcome.
| score on a scale | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) |
|---|---|---|---|
| Evidence-Based Practices Use (EBPU) | 4.07 ± 2.46 | 4.21 ± 2.65 | 4.09 ± 2.48 |
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).
| score on a scale | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) |
|---|---|---|---|
| Baseline | 42.14 ± 23.25 | 43.14 ± 21.15 | 40.90 ± 21.15 |
| 8-Month | 35.60 ± 20.58 | 33.63 ± 21.26 | 36.61 ± 21.38 |
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).
| score on a scale | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) |
|---|---|---|---|
| Natural Disaster | 4.08 ± 2.53 | 3.71 ± 2.05 | 2.94 ± 2.21 |
| Fire or Explosion | 3.86 ± 2.21 | 3.52 ± 2.48 | 3.09 ± 2.37 |
| Transportation Accident | 4.28 ± 1.90 | 3.84 ± 2.49 | 3.09 ± 2.25 |
| Serious Accident at Work/Home/Recreational | 4.06 ± 1.53 | 4.67 ± 2.54 | 5.36 ± 1.43 |
| Exposure to Toxic Substance | 4.00 ± 2.97 | 4.88 ± 2.64 | 5.00 ± 1.89 |
| Physical Assault Without a Weapon | 4.96 ± 1.97 | 4.66 ± 2.43 | 4.24 ± 2.31 |
| Assault With a Weapon | 4.82 ± 1.97 | 5.04 ± 2.29 | 3.81 ± 2.35 |
| Sexual Assault | 5.82 ± 1.68 | 5.60 ± 2.31 | 4.73 ± 2.27 |
| Other Unwanted or Uncomfortable Sexual Experience | 5.12 ± 1.50 | 5.05 ± 2.46 | 5.08 ± 2.47 |
| Combat | 2.80 ± 1.30 | 4.00 ± 4.24 | 3.30 ± 2.41 |
| Captivity | 5.62 ± 2.07 | 5.33 ± 1.51 | 6.00 ± 1.31 |
| Life-threatening Illness or Injury | 5.00 ± 1.80 | 4.63 ± 2.36 | 4.38 ± 2.33 |
| Severe Human Suffering | 5.41 ± 1.42 | 5.14 ± 2.32 | 5.57 ± 1.79 |
| Serious Injury, Harm, or Death Caused | 5.67 ± 1.21 | 3.56 ± 2.83 | 6.11 ± 1.36 |
| Incarceration | 4.52 ± 2.15 | 3.86 ± 2.70 | 4.15 ± 2.49 |
| Homelessness | 4.60 ± 2.16 | 5.06 ± 2.59 | 4.75 ± 2.34 |
| Involuntary Hospitalization | 4.26 ± 2.33 | 3.94 ± 2.72 | 4.65 ± 2.18 |
| Exposure to Neighborhood Violence | 4.61 ± 2.31 | 4.45 ± 2.34 | 4.97 ± 2.00 |
| Any Other Very Stressful Event | 6.67 ± 0.52 | 6.27 ± 1.27 | 5.71 ± 1.38 |
Collected over 2 years, 11 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Behavioral Weight Loss Intervention | 0/69 (0%) | 1/69 (1.4%) | 0/69 (0%) |
| BWLI & Peer Navigator | 0/74 (0%) | 1/74 (1.4%) | 0/74 (0%) |
| Integrated Care (Treatment as Usual) | 0/70 (0%) | 0/70 (0%) | 0/70 (0%) |
| Event | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) |
|---|---|---|---|
| Difficulty walking to interview, back painGeneral disorders | 1/69 | 0/74 | 0/70 |
| High blood pressure observed at interviewGeneral disorders | 0/69 | 1/74 | — |
| Age, Categorical(Participants) | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 66 | 69 | 68 | 203 |
| >=65 years | 3 | 5 | 2 | 10 |
| Age, Continuous(years) | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) | Total |
|---|---|---|---|---|
| Mean | 49.93 ± 10.48 | 52.91 ± 8.81 | 51.37 ± 8.55 | 51.4 ± 9.30 |
| Sex: Female, Male(Participants) | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) | Total |
|---|---|---|---|---|
| Female | 44 | 40 | 40 | 124 |
| Male | 25 | 34 | 30 | 89 |
| Race/Ethnicity, Customized(participants) | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) | Total |
|---|---|---|---|---|
| American Indian/Alaskan Native | 3 | 3 | 6 | 12 |
| Asian | 1 | 1 | 0 | 2 |
| White/Caucasian | 9 | 2 | 4 | 15 |
| Native Hawaiian/Pacific Islander | 0 | 2 | 1 | 3 |
| Other | 3 | 2 | 3 | 8 |
| Hispanic/Latino | 4 | 5 | 1 | 10 |
| African American | 69 | 74 | 70 | 213 |
| Region of Enrollment(participants) | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) | Total |
|---|---|---|---|---|
| United States | 69 | 74 | 70 | 213 |
| SF-36 Subscale: General Health(units on a scale) | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) | Total |
|---|---|---|---|---|
| Mean | 60.20 ± 23.05 | 58.00 ± 22.11 | 59.13 ± 22.66 | 58.59 ± 22.72 |
| SF-36 Subscale: Bodily Pain(units on a scale) | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) | Total |
|---|---|---|---|---|
| Mean | 59.87 ± 26.25 | 61.94 ± 28.91 | 59.96 ± 27.31 | 61.15 ± 26.90 |
| SF-36 Subscale: Physical Functioning(units on a scale) | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) | Total |
|---|---|---|---|---|
| Mean | 63.86 ± 25.07 | 67.00 ± 26.51 | 69.23 ± 22.20 | 66.02 ± 25.69 |
9 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Time frame: Data will be available on 12-31-2020.
Access criteria: 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.
Data sharing details ↗ · www.chicagohealthdisparities.org
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