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

NCT03382782 | Completed Results

• 1 other identifier: 1U01MD010541
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 3

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.

Conditions

Obesity; Mental Disorder

Keywords

Obesity; Mental Disorder; Peer Navigator; Physical Health; Overweight; Serious Mental Illness

Outcome Measures

Primary Outcomes (1)

• Weight

  Change in Weight (pounds/lbs)

  0, 4, 8 and 12 months

Secondary Outcomes (12)

• Quality of Life Scale (QLS)

  0, 8 months

• Recovery Assessment Scale-Revised (RAS-R)

  0, 8 months

• Weight Efficacy Lifetime (WEL) Questionnaire

  0, 8 months

• Self-Efficacy for Exercise Scale

  0, 8 months

• Waist Circumference

  0, 4, 8, 12 months

Study Arms (3)

Behavioral Weight Loss Intervention

ACTIVE COMPARATOR

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

BWLI & Peer Navigator

EXPERIMENTAL

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

Integrated Care (Treatment as Usual)

ACTIVE COMPARATOR

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

Interventions

BWLI BEHAVIORAL

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.

Behavioral Weight Loss Intervention

BWLI & Peer Navigator BEHAVIORAL

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.

BWLI & Peer Navigator

Integrated Care BEHAVIORAL

Participants receive integrated physical and mental health care from their usual provider.

Integrated Care (Treatment as Usual)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants must identify as female or male.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Illinois Institute of Technology: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• ACCESS Community Health Network: collaborator
• Trilogy Inc. Behavioral Healthcare: collaborator

Study Sites (3)

Illinois Institute of Technology

Chicago, Illinois, 60616, United States

Location

Trilogy Behavioral Healthcare

Chicago, Illinois, 60626, United States

Location

Access Community Health Network

Chicago, Illinois, 60661, United States

Location

Related Publications (6)

• 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.

  PMID: 24467470 BACKGROUND

• 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.

  PMID: 28093056 BACKGROUND

• 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.

  PMID: 21379357 BACKGROUND

• 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.

  PMID: 17985954 BACKGROUND

• 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.

  PMID: 23584716 BACKGROUND

• 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.

  PMID: 19648193 BACKGROUND

Related Links

• World Health Organization, 2005. Information Sheet: Premature Death Among People with Mental Illness.

MeSH Terms

Conditions

Obesity; Mental Disorders; Overweight

Interventions

Delivery of Health Care, Integrated

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation

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.

Results Point of Contact

• Title: Dr. Lindsay Sheehan, Co-Investigator
• Organization: Illinois Institute of Technology

lsheehan@iit.edu

312-567-7983

Study Officials

• Patrick Corrigan, PsyD

  Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor of Psychology

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: December 26, 2017
• Study Start: December 12, 2017
• Primary Completion: March 12, 2020
• Study Completion: March 11, 2021
• Last Updated: December 8, 2023
• Results First Posted: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available on 12-31-2020.
• Access Criteria: To ensure the protection of the human subjects involved in our research, investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Locations

US (3)