Peer Navigators to Address Obesity-Related Concerns for African Americans With Serious Mental Illness

Study Overview
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Brief Summary
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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
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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: 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 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.

Official Title
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Peer Navigators to Address Obesity-Related Concerns for African Americans With Serious Mental Illness

Conditions
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Obesity, Mental Disorder

Intervention / Treatment
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* Behavioral: BWLI
* Behavioral: BWLI & Peer Navigator
* Behavioral: Integrated Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Behavioral Weight Loss Intervention<br>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<br>* 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.<br>|
| Experimental: BWLI & Peer Navigator<br>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<br>* 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.<br>|
| Active Comparator: Integrated Care (Treatment as Usual)<br>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<br>* Participants receive integrated physical and mental health care from their usual provider.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Change in Weight (pounds/lbs) | 0, 4, 8 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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. | 0, 8 months | 
| Waist Circumference | Change in waist circumference | 0, 4, 8, 12 months | 
| Blood Pressure | Mean diastolic and systolic blood pressure (BP), in millimeters of mercury (mmHg) across 4 time frames. | 0, 4, 8, 12 months | 
| Height | Measure participants' height (inches) | 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. | 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). | 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. | 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). | 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). | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Mental Disorder, Peer Navigator, Physical Health, Overweight, Serious Mental Illness