N/A
N=106
Peer Navigators to Address Obesity-Related Concerns for African Americans With Serious Mental Illness
Obesity · Mental Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03382782 ↗Enrolled (actual)
106
Serious AEs
0.9%
Results posted
Dec 2023
Primary outcome: Primary: Weight — 226.54; 225.46; 218.19; 225.63 pounds (lbs) — p=.025
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BWLI (Behavioral); BWLI & Peer Navigator (Behavioral); Integrated Care (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Illinois Institute of Technology
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight |
226.54; 225.46; 218.19; 225.63; 223.21; 214.85 | .025 sig |
| SECONDARY Quality of Life Scale (QLS) |
27.61; 27.00; 27.58; 28.63; 28.53; 29.49 | 0.784 |
| SECONDARY Recovery Assessment Scale-Revised (RAS-R) |
95.73; 95.32; 98.21; 98.72; 98.85; 97.65 | 0.174 |
| SECONDARY Weight Efficacy Lifetime (WEL) Questionnaire |
102.83; 99.22; 99.26; 124.72; 116.13; 109.93 | 0.261 |
| SECONDARY Self-Efficacy for Exercise Scale |
74.05; 69.02; 76.56; 66.34; 62.10; 67.15 | — |
| SECONDARY Waist Circumference |
46.00; 43.85; 44.99; 45.56; 44.78; 44.60 | 0.11 |
| SECONDARY Blood Pressure |
127.39; 124.98; 126.85; 89.11; 92.10; 90.27 | 0.09 |
| SECONDARY Height |
65.38; 66.68; 66.29 | — |
| SECONDARY 36-Item Short Form Health Survey (SF-36) |
60.20; 58.00; 59.13; 59.87; 61.94; 59.96 | 0.121 |
| SECONDARY Center for Epidemiologic Studies Depression Scale-Depression(CES-D) |
23.79; 23.67; 21.93; 21.04; 20.53; 20.07 | .855 |
| SECONDARY Evidence-Based Practices Use (EBPU) |
4.07; 4.21; 4.09 | — |
| SECONDARY Emotional Eating Scale (EES) |
42.14; 43.14; 40.90; 35.60; 33.63; 36.61 | 0.508 |
| SECONDARY Life Events Checklist for DSM-5 |
4.08; 3.71; 2.94; 3.86; 3.52; 3.09 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- African American
- Age 18 or older
- Serious mental illness (as indicated by disability)
- Identifies as either male or female
- Concerned about weight and health goals
- Willing to attend
- BMI of greater than or equal to 28
Exclusion Criteria
- Currently receiving services from a peer support specialist or community health worker to work on weight-related goals
- Weigh more than 440 pounds
- Lifetime diagnosis of eating disorder
- Pregnant or plan to become pregnant
- Lifetime bariatric surgery
- No doctor permission for exercise
- Taking medication for weight loss
Data sourced from ClinicalTrials.gov (NCT03382782). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.