| Registry | NCT03382782 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 234 (Actual) |
| Sponsor | Illinois Institute of Technology (Other); collaborators: National Institute on Minority Health and Health Disparities (NIMHD), ACCESS Community Health Network, Trilogy Inc. Behavioral Healthcare |
| Conditions | Obesity, Mental Disorder |
| Interventions | BWLI, BWLI & Peer Navigator, Integrated Care (Behavioral) |
| Dates | start 2017-12-12, primary completion 2020-03-12, completion 2021-03-11, first posted 2017-12-26, last updated 2023-12-08 |
| Locations | 3 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Obesity All trials for Mental Disorder All trials of BWLI All trials of BWLI & Peer Navigator
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:
1. A BWLI developed for persons with serious mental illness (Goldberg et al., 2013) that will be evaluated for its responsiveness to the needs of African Americans with serious mental illness
2. A peer navigator program (PNP) (Corrigan et al., 2017) that assists people with serious mental illness in meeting their health needs in the community; the PNP will be adapted so peer navigators can augment the impact of BWLI in food and activity deserts.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Behavioral Weight Loss Intervention | Active comparator | Behavioral: BWLI | 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 | Experimental | Behavioral: 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. |
| Integrated Care (Treatment as Usual) | Active comparator | Behavioral: Integrated Care | 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. |
Sex: All, ages: 18 Years to any
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
| 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 |
Time frame: 2 years, 11 months
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Behavioral Weight Loss Intervention | 0/69 (0.0%) | 1/69 (1.4%) | 0/69 (0.0%) |
| BWLI & Peer Navigator | 0/74 (0.0%) | 1/74 (1.4%) | 0/74 (0.0%) |
| Integrated Care (Treatment as Usual) | 0/70 (0.0%) | 0/70 (0.0%) | 0/70 (0.0%) |
| Term | Organ system | Behavioral Weight Loss Intervention | BWLI & Peer Navigator | Integrated Care (Treatment as Usual) |
|---|---|---|---|---|
| High blood pressure observed at interview | General disorders | 0/69 | 1/74 | 0/70 |
| Difficulty walking to interview, back pain | General disorders | 1/69 | 0/74 | 0/70 |
Limitations and caveats: 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Illinois Institute of Technology | Chicago, Illinois | United States | |
| Trilogy Behavioral Healthcare | Chicago, Illinois | United States | |
| Access Community Health Network | Chicago, Illinois | United States |
NIH grants: U01MD010541