18 and older, any sex, with Obesity or Mental Disorder. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
WeightPrimary· 0, 4, 8 and 12 months
Change in Weight (pounds/lbs)
Baseline
Group
Value
95% CI
Behavioral Weight Loss Intervention
226.54
± 41.22
BWLI & Peer Navigator
225.46
± 52.94
Integrated Care (Treatment as Usual)
218.19
± 40.41
4-Month
Group
Value
95% CI
Behavioral Weight Loss Intervention
225.63
± 42.58
BWLI & Peer Navigator
223.21
± 51.27
Integrated Care (Treatment as Usual)
214.85
± 40.99
8-Month
Group
Value
95% CI
Behavioral Weight Loss Intervention
227.66
± 42.12
BWLI & Peer Navigator
223.25
± 50.63
Integrated Care (Treatment as Usual)
216.03
± 39.62
12-Month
Group
Value
95% CI
Behavioral Weight Loss Intervention
228.86
± 41.29
BWLI & Peer Navigator
222.41
± 50.13
Integrated Care (Treatment as Usual)
216.65
± 39.54
Quality of Life Scale (QLS)Secondary· 0, 8 months
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).
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).
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).
Baseline
Group
Value
95% CI
Behavioral Weight Loss Intervention
102.83
± 38.32
BWLI & Peer Navigator
99.22
± 31.48
Integrated Care (Treatment as Usual)
99.26
± 32.35
8-Month
Group
Value
95% CI
Behavioral Weight Loss Intervention
124.72
± 33.81
BWLI & Peer Navigator
116.13
± 32.40
Integrated Care (Treatment as Usual)
109.93
± 39.06
Self-Efficacy for Exercise ScaleSecondary· 0, 8 months
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 Month
Group
Value
95% CI
Behavioral Weight Loss Intervention
74.05
± 24.50
BWLI & Peer Navigator
69.02
± 23.88
Integrated Care (Treatment as Usual)
76.56
± 22.70
8 Month
Group
Value
95% CI
Behavioral Weight Loss Intervention
66.34
± 24.28
BWLI & Peer Navigator
62.10
± 25.62
Integrated Care (Treatment as Usual)
67.15
± 23.82
Waist CircumferenceSecondary· 0, 4, 8, 12 months
Change in waist circumference
0 Months (Baseline)
Group
Value
95% CI
Behavioral Weight Loss Intervention
46.00
± 4.54
BWLI & Peer Navigator
43.85
± 6.18
Integrated Care (Treatment as Usual)
44.99
± 5.61
4 Months
Group
Value
95% CI
Behavioral Weight Loss Intervention
45.56
± 4.90
BWLI & Peer Navigator
44.78
± 6.90
Integrated Care (Treatment as Usual)
44.60
± 6.34
8 Months
Group
Value
95% CI
Behavioral Weight Loss Intervention
46.23
± 4.69
BWLI & Peer Navigator
44.36
± 6.44
Integrated Care (Treatment as Usual)
43.82
± 6.16
12 Months
Group
Value
95% CI
Behavioral Weight Loss Intervention
45.98
± 5.04
BWLI & Peer Navigator
44.13
± 6.58
Integrated Care (Treatment as Usual)
43.99
± 5.59
Blood PressureSecondary· 0, 4, 8, 12 months
Mean diastolic and systolic blood pressure (BP), in millimeters of mercury (mmHg) across 4 time frames.
0 Month (Baseline) Mean systolic BP
Group
Value
95% CI
Behavioral Weight Loss Intervention
127.39
± 15.52
BWLI & Peer Navigator
124.98
± 25.97
Integrated Care (Treatment as Usual)
126.85
± 25.79
0 Month (Baseline) Mean diastolic BP
Group
Value
95% CI
Behavioral Weight Loss Intervention
89.11
± 13.12
BWLI & Peer Navigator
92.10
± 12.55
Integrated Care (Treatment as Usual)
90.27
± 14.23
4 Month Mean systolic BP
Group
Value
95% CI
Behavioral Weight Loss Intervention
129.35
± 18.34
BWLI & Peer Navigator
129.12
± 25.78
Integrated Care (Treatment as Usual)
125.93
± 15.99
4 Month Mean diastolic BP
Group
Value
95% CI
Behavioral Weight Loss Intervention
87.22
± 14.13
BWLI & Peer Navigator
86.62
± 14.54
Integrated Care (Treatment as Usual)
84.50
± 10.06
8 Month Mean systolic BP
Group
Value
95% CI
Behavioral Weight Loss Intervention
132.83
± 21.30
BWLI & Peer Navigator
124.80
± 21.18
Integrated Care (Treatment as Usual)
125.43
± 18.22
8 Month Mean diastolic BP
Group
Value
95% CI
Behavioral Weight Loss Intervention
86.87
± 13.79
BWLI & Peer Navigator
83.20
± 12.31
Integrated Care (Treatment as Usual)
85.63
± 13.16
12 Month Mean systolic BP
Group
Value
95% CI
Behavioral Weight Loss Intervention
130.06
± 19.89
BWLI & Peer Navigator
133.68
± 24.34
Integrated Care (Treatment as Usual)
130.95
± 14.02
12 Month Mean diastolic BP
Group
Value
95% CI
Behavioral Weight Loss Intervention
86.70
± 13.25
BWLI & Peer Navigator
87.46
± 12.06
Integrated Care (Treatment as Usual)
86.52
± 9.26
HeightSecondary· 0 Month (Baseline)
Measure participants' height (inches)
Group
Value
95% CI
Behavioral Weight Loss Intervention
65.38
± 3.65
BWLI & Peer Navigator
66.68
± 3.85
Integrated Care (Treatment as Usual)
66.29
± 4.70
36-Item Short Form Health Survey (SF-36)Secondary· 0, 8 months
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 Month-General Health Subscale (Baseline)
Group
Value
95% CI
Behavioral Weight Loss Intervention
60.20
± 23.05
BWLI & Peer Navigator
58.00
± 22.11
Integrated Care (Treatment as Usual)
59.13
± 22.66
0 Month-Bodily Pain Subscale (Baseline)
Group
Value
95% CI
Behavioral Weight Loss Intervention
59.87
± 26.25
BWLI & Peer Navigator
61.94
± 28.91
Integrated Care (Treatment as Usual)
59.96
± 27.31
0 Month-Physical Functioning Subscale (Baseline)
Group
Value
95% CI
Behavioral Weight Loss Intervention
63.86
± 25.07
BWLI & Peer Navigator
67.00
± 26.51
Integrated Care (Treatment as Usual)
69.23
± 22.20
0 Month-Emotional Well-Being Subscale (Baseline)
Group
Value
95% CI
Behavioral Weight Loss Intervention
63.58
± 20.57
BWLI & Peer Navigator
60.43
± 21.17
Integrated Care (Treatment as Usual)
63.43
± 23.53
8 Month-General Health Subscale
Group
Value
95% CI
Behavioral Weight Loss Intervention
62.11
± 20.53
BWLI & Peer Navigator
64.23
± 21.96
Integrated Care (Treatment as Usual)
58.17
± 24.92
8 Month-Bodily Pain Subscale
Group
Value
95% CI
Behavioral Weight Loss Intervention
58.11
± 27.13
BWLI & Peer Navigator
63.25
± 29.94
Integrated Care (Treatment as Usual)
59.52
± 26.29
8 Month-Physical Functioning Subscale
Group
Value
95% CI
Behavioral Weight Loss Intervention
59.74
± 27.72
BWLI & Peer Navigator
68.54
± 27.23
Integrated Care (Treatment as Usual)
60.48
± 28.12
8 Month-Emotional Well-Being Subscale
Group
Value
95% CI
Behavioral Weight Loss Intervention
64.49
± 20.70
BWLI & Peer Navigator
67.20
± 18.27
Integrated Care (Treatment as Usual)
68.32
± 18.86
Center for Epidemiologic Studies Depression Scale-Depression(CES-D)Secondary· 0, 8 months
Assess change in participants' experienced symptoms associated with depression. 10 items. Range from 0-60. Higher score indicates worse outcome (greater depressive symptoms).
Baseline
Group
Value
95% CI
Behavioral Weight Loss Intervention
23.79
± 11.87
BWLI & Peer Navigator
23.67
± 10.97
Integrated Care (Treatment as Usual)
21.93
± 11.25
8-Month
Group
Value
95% CI
Behavioral Weight Loss Intervention
21.04
± 12.93
BWLI & Peer Navigator
20.53
± 12.09
Integrated Care (Treatment as Usual)
20.07
± 11.22
Evidence-Based Practices Use (EBPU)Secondary· 0 months
Assess change in participants' enrollment in clinical and service interventions. Range from 0-10, higher scores = better outcome.
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).
Baseline
Group
Value
95% CI
Behavioral Weight Loss Intervention
42.14
± 23.25
BWLI & Peer Navigator
43.14
± 21.15
Integrated Care (Treatment as Usual)
40.90
± 21.15
8-Month
Group
Value
95% CI
Behavioral Weight Loss Intervention
35.60
± 20.58
BWLI & Peer Navigator
33.63
± 21.26
Integrated Care (Treatment as Usual)
36.61
± 21.38
Adverse events — posted to ClinicalTrials.gov
Time frame: 2 years, 11 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Illinois Institute of Technology
Last refreshed: 8 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03382782.