Peer Navigators to Address Obesity-Related Concerns for African Americans With Serious Mental Illness
NCT ID: NCT03382782
Last Updated: 2023-12-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
234 participants
INTERVENTIONAL
2017-12-12
2021-03-11
Brief Summary
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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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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Behavioral Weight Loss Intervention
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
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.
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.
BWLI & Peer Navigator
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.
Integrated Care (Treatment as Usual)
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.
Integrated Care
Participants receive integrated physical and mental health care from their usual provider.
Interventions
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BWLI
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.
BWLI & Peer Navigator
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.
Integrated Care
Participants receive integrated physical and mental health care from their usual provider.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Institute on Minority Health and Health Disparities (NIMHD)
NIH
ACCESS Community Health Network
OTHER
Trilogy Inc. Behavioral Healthcare
OTHER
Illinois Institute of Technology
OTHER
Responsible Party
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Patrick Corrigan
Distinguished Professor of Psychology
Principal Investigators
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Patrick Corrigan, PsyD
Role: PRINCIPAL_INVESTIGATOR
Illinois Institute of Technology
Locations
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Illinois Institute of Technology
Chicago, Illinois, United States
Trilogy Behavioral Healthcare
Chicago, Illinois, United States
Access Community Health Network
Chicago, Illinois, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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World Health Organization, 2005. Information Sheet: Premature Death Among People with Mental Illness.