Clinical trial NCT03382782: Peer Navigators to Address Obesity-Related Concerns for African Americans With Serious Mental Illness
Official title: Peer Navigators to Address Obesity-Related Concerns for African Americans With Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Mental Disorder
Keywords: Obesity
Mental Disorder
Peer Navigator
Physical Health
Overweight
Serious Mental Illness
Lead sponsor: Illinois Institute of Technology
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: ACCESS Community Health Network
name: Trilogy Inc. Behavioral Healthcare
First posted: 2017-12-26
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Weight
timeFrame: 0, 4, 8 and 12 months
Secondary outcomes:
measure: Quality of Life Scale (QLS)
timeFrame: 0, 8 months
measure: Recovery Assessment Scale-Revised (RAS-R)
timeFrame: 0, 8 months
measure: Weight Efficacy Lifetime (WEL) Questionnaire
timeFrame: 0, 8 months
measure: Self-Efficacy for Exercise Scale
timeFrame: 0, 8 months
measure: Waist Circumference
timeFrame: 0, 4, 8, 12 months
measure: Blood Pressure
timeFrame: 0, 4, 8, 12 months
measure: Height
timeFrame: 0 Month (Baseline)
measure: 36-Item Short Form Health Survey (SF-36)
timeFrame: 0, 8 months
measure: Center for Epidemiologic Studies Depression Scale-Depression(CES-D)
timeFrame: 0, 8 months
measure: Evidence-Based Practices Use (EBPU)
timeFrame: 0 months
measure: Emotional Eating Scale (EES)
timeFrame: 0, 8 months
measure: Life Events Checklist for DSM-5
timeFrame: Baseline
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Illinois Institute of Technology
state: Illinois
city: Chicago
country: United States
facility: Trilogy Behavioral Healthcare
state: Illinois
city: Chicago
country: United States
facility: Access Community Health Network
state: Illinois
Study officials:
affiliation: Illinois Institute of Technology
name: Patrick Corrigan, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.