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

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ClinicalTrials.gov Identifier: NCT03382782
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : May 2, 2018
Sponsor:
Collaborators:
National Institute on Minority Health and Health Disparities (NIMHD)
Heartland Alliance Health
Access Community Health Network
Information provided by (Responsible Party):
Patrick Corrigan, Illinois Institute of Technology

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 6-month intervention phase and 2-month maintenance phase, which 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 an 18-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.


Condition or disease Intervention/treatment Phase
Obesity Mental Disorder Behavioral: BWLI Behavioral: BWLI & Peer Navigator Behavioral: Integrated Care Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The behavioral weight loss intervention (BWLI) consists of a 6-month intervention phase followed by a 6-month maintenance phase. The initial intervention phase comprises four types of contact: 1) 2-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 twelve 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)
Primary Purpose: Treatment
Official Title: Peer Navigators to Address Obesity-Related Concerns for African Americans With Serious Mental Illness
Actual Study Start Date : December 12, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Behavioral Weight Loss Intervention

Participants will enroll in the BWLI program for 8 months. BWLI consists of a 6-month initial intervention phase followed by 2-month maintenance phase. The initial intervention phase comprises four types of contact:

  • 2 hour, group weight-management class led by facilitator (once per week);
  • 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).

During the maintenance phase, 8 weight management review classes take place weekly. Other activities remain the same.

Behavioral: 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.

Experimental: 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.
Behavioral: BWLI & Peer Navigator
Participants receive the BWLI condition and are assigned to a peer navigator. Peer navigators will meet individually and face-to-face with research participants on activities to meet participant health and weight goals, such as through partnering on BWLI homework, attending health care appointments, and facilitating diet and exercise goals in participant communities.

Active Comparator: 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.
Behavioral: Integrated Care
Participants receive integrated physical and mental health care from their usual provider.




Primary Outcome Measures :
  1. Weight [ Time Frame: 0, 4, 8 and 12 months ]
    Change in Weight


Secondary Outcome Measures :
  1. Quality of Life Scale (QLS) [ Time Frame: 0, 4, 8, 12 months ]
    Assesses life domains including general life, daily activities, and social contact. Participants respond on a 7-point scale from "delighted" to "terrible".

  2. Recovery Assessment Scale-Revised (RAS-R) [ Time Frame: 0, 4, 8, 12 months ]
    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.

  3. Weight Efficacy Lifetime Questionnaire [ Time Frame: 0,4, 8, 12 months ]
    Assesses participant confidence in resisting eating in some typical eating situations.

  4. Self-Efficacy for Exercise Scale [ Time Frame: 0, 4, 8, 12 months ]
    Assesses participant beliefs in their ability to continue exercising on a three-time per week basis at moderate intensities

  5. Waist Circumference [ Time Frame: 0, 4, 8, 12 months ]
    Change in waist circumference

  6. Blood Pressure [ Time Frame: 0, 12 months ]
    Change in blood pressure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participants must identify as female or male.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • African American
  • Age 18 or older
  • Serious mental illness (as indicated by disability)
  • Identifies as male or female
  • Access to integrated care services
  • Concerned about weight and health goals
  • Willing to attend
  • BMI of greater than or equal to 25

Exclusion Criteria:

  • Currently receiving services from a peer support specialist or community health worker to work on weight-related goals
  • Weigh more than 400 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382782


Contacts
Contact: Patrick Corrigan, PsyD 312-567-7983 corrigan@iit.edu
Contact: Sonya Ballentine 312-567-7969 sballent@iit.edu

Locations
United States, Illinois
Illinois Institute of Technology Recruiting
Chicago, Illinois, United States, 60616
Contact: Patrick Corrigan, PsyD    312-567-6751    corrigan@iit.edu   
Contact: Sonya Ballentine    312-567-7969    sballent@iit.edu   
Principal Investigator: Patrick Corrigan, PsyD         
Heartland Health Centers Recruiting
Chicago, Illinois, United States, 60640
Contact: Erin Hantke, MPH    773-751-1744    EHantke@heartlandalliance.org   
Access Community Health Network Not yet recruiting
Chicago, Illinois, United States, 60661
Contact: Danielle Lazar    773-247-2415    Danielle.Lazar@achn.net   
Sponsors and Collaborators
Illinois Institute of Technology
National Institute on Minority Health and Health Disparities (NIMHD)
Heartland Alliance Health
Access Community Health Network
Investigators
Principal Investigator: Patrick Corrigan, PsyD Illinois Institute of Technology

Additional Information:
Publications:
Responsible Party: Patrick Corrigan, Distinguished Professor of Psychology, Illinois Institute of Technology
ClinicalTrials.gov Identifier: NCT03382782     History of Changes
Other Study ID Numbers: 1U01MD010541 ( U.S. NIH Grant/Contract )
1U01MD010541 ( U.S. NIH Grant/Contract )
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
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.
URL: http://www.chicagohealthdisparities.org

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Patrick Corrigan, Illinois Institute of Technology:
Obesity
Mental Disorder
Peer Navigator
Physical Health
Overweight
Serious Mental Illness

Additional relevant MeSH terms:
Obesity
Mental Disorders
Psychotic Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders