Peer Navigators to Address Obesity-Related Concerns for African Americans With Serious Mental Illness
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03382782|
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : May 2, 2018
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|
|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)|
|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|
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:
During the maintenance phase, 8 weight management review classes take place weekly. Other activities remain the same.
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:
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.
- Weight [ Time Frame: 0, 4, 8 and 12 months ]Change in Weight
- 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".
- 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.
- Weight Efficacy Lifetime Questionnaire [ Time Frame: 0,4, 8, 12 months ]Assesses participant confidence in resisting eating in some typical eating situations.
- 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
- Waist Circumference [ Time Frame: 0, 4, 8, 12 months ]Change in waist circumference
- Blood Pressure [ Time Frame: 0, 12 months ]Change in blood pressure
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
|Contact: Patrick Corrigan, PsyDemail@example.com|
|Contact: Sonya Ballentinefirstname.lastname@example.org|
|United States, Illinois|
|Illinois Institute of Technology||Recruiting|
|Chicago, Illinois, United States, 60616|
|Contact: Patrick Corrigan, PsyD 312-567-6751 email@example.com|
|Contact: Sonya Ballentine 312-567-7969 firstname.lastname@example.org|
|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|
|Principal Investigator:||Patrick Corrigan, PsyD||Illinois Institute of Technology|