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

Primary Purpose

Obesity, Mental Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BWLI
BWLI & Peer Navigator
Integrated Care
Sponsored by
Illinois Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Mental Disorder, Peer Navigator, Physical Health, Overweight, Serious Mental Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Illinois Institute of Technology
  • Trilogy Behavioral Healthcare
  • Access Community Health Network

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Behavioral Weight Loss Intervention

BWLI & Peer Navigator

Integrated Care (Treatment as Usual)

Arm Description

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).

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.

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.

Outcomes

Primary Outcome Measures

Weight
Change in Weight

Secondary Outcome Measures

Quality of Life Scale (QLS)
Assesses life domains including general life, daily activities, and social contact. Participants respond on a 7-point scale from "delighted" to "terrible".
Recovery Assessment Scale-Revised (RAS-R)
Measure of recovery with 24 items. 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.
Weight Efficacy Lifetime Questionnaire
Assesses participant confidence in resisting eating in some typical eating situations.
Self-Efficacy for Exercise Scale
Assesses participant beliefs in their ability to continue exercising on a three-time per week basis at moderate intensities
Waist Circumference
Change in waist circumference
Blood Pressure
Change in blood pressure
Height
Measure participants' height
36-Item Short From Health Survey (SF-36)
Assess change in participants's health status and health related quality of life
Center for Epidemiologic Studies Depression Scale-Depression(CES-D)
Assess change in participants' experienced symptoms associated with depression
Evidence-Based Practices Use (EBPU)
Assess change in participants' enrollment in clinical and service interventions.
Emotional Eating Scale (EES)
Assess change in participants' experienced negative emotions and their relationships with desire to eat.
Life Events Checklist for DSM-5
Assess participants experiences of potential traumatic events

Full Information

First Posted
December 19, 2017
Last Updated
March 30, 2022
Sponsor
Illinois Institute of Technology
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), ACCESS Community Health Network, Trilogy
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1. Study Identification

Unique Protocol Identification Number
NCT03382782
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 12, 2017 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
March 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Illinois Institute of Technology
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), ACCESS Community Health Network, Trilogy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Mental Disorder
Keywords
Obesity, Mental Disorder, Peer Navigator, Physical Health, Overweight, Serious Mental Illness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
213 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Weight Loss Intervention
Arm Type
Active Comparator
Arm Description
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).
Arm Title
BWLI & Peer Navigator
Arm Type
Experimental
Arm Description
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.
Arm Title
Integrated Care (Treatment as Usual)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
BWLI
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
BWLI & Peer Navigator
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Integrated Care
Intervention Description
Participants receive integrated physical and mental health care from their usual provider.
Primary Outcome Measure Information:
Title
Weight
Description
Change in Weight
Time Frame
0, 4, 8 and 12 months
Secondary Outcome Measure Information:
Title
Quality of Life Scale (QLS)
Description
Assesses life domains including general life, daily activities, and social contact. Participants respond on a 7-point scale from "delighted" to "terrible".
Time Frame
0, 4, 8, 12 months
Title
Recovery Assessment Scale-Revised (RAS-R)
Description
Measure of recovery with 24 items. 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.
Time Frame
0, 4, 8, 12 months
Title
Weight Efficacy Lifetime Questionnaire
Description
Assesses participant confidence in resisting eating in some typical eating situations.
Time Frame
0,4, 8, 12 months
Title
Self-Efficacy for Exercise Scale
Description
Assesses participant beliefs in their ability to continue exercising on a three-time per week basis at moderate intensities
Time Frame
0, 4, 8, 12 months
Title
Waist Circumference
Description
Change in waist circumference
Time Frame
0, 4, 8, 12 months
Title
Blood Pressure
Description
Change in blood pressure
Time Frame
0, 4, 8, 12 months
Title
Height
Description
Measure participants' height
Time Frame
Baseline
Title
36-Item Short From Health Survey (SF-36)
Description
Assess change in participants's health status and health related quality of life
Time Frame
0, 4, 8, 12 months
Title
Center for Epidemiologic Studies Depression Scale-Depression(CES-D)
Description
Assess change in participants' experienced symptoms associated with depression
Time Frame
0, 4, 8, 12 months
Title
Evidence-Based Practices Use (EBPU)
Description
Assess change in participants' enrollment in clinical and service interventions.
Time Frame
0, 4, 8, 12 months
Title
Emotional Eating Scale (EES)
Description
Assess change in participants' experienced negative emotions and their relationships with desire to eat.
Time Frame
0, 4, 8, 12 months
Title
Life Events Checklist for DSM-5
Description
Assess participants experiences of potential traumatic events
Time Frame
Baseline

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Participants must identify as female or male.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Corrigan, PsyD
Organizational Affiliation
Illinois Institute of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Illinois Institute of Technology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Trilogy Behavioral Healthcare
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60626
Country
United States
Facility Name
Access Community Health Network
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60661
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Results will be available to researchers and service agencies, with quantitative data available from an expected 210 African American participants with serious mental illness who report concerns obesity or being overweight. No identifying information will be connected to the data and investigators do not believe that there is a possibility of deductive disclosure of subjects with unusual characteristics. Regardless, to ensure the protection of the human subjects involved in this research, investigators will make the data and associated documentation available to users only under a data-sharing agreement. Notice of available data will be posted in appropriate arenas including websites for the project: www.chicagohealthdisparities.org and www.ncse1.org.
IPD Sharing Time Frame
Data will be available on 12-31-2020.
IPD Sharing 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.
IPD Sharing URL
http://www.chicagohealthdisparities.org
Citations:
PubMed Identifier
24467470
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.
Results Reference
background
PubMed Identifier
28093056
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.
Results Reference
background
PubMed Identifier
21379357
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.
Results Reference
background
PubMed Identifier
17985954
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.
Results Reference
background
PubMed Identifier
23584716
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.
Results Reference
background
PubMed Identifier
19648193
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.
Results Reference
background

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

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