Peer Navigators to Address Obesity-Related Concerns for African Americans With Serious Mental Illness
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Psychiatric, Psychiatric |
| Therapuetic Areas: | Endocrinology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/10/2019 |
| Start Date: | December 12, 2017 |
| End Date: | December 31, 2020 |
| Contact: | Patrick Corrigan, PsyD |
| Email: | corrigan@iit.edu |
| Phone: | 312-567-7983 |
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.
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.
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:
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.
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:
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.
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 30
- Lives within 40 minutes of study site by public transit
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
We found this trial at
3
sites
10 West 35th Street
Chicago, Illinois 60616
Chicago, Illinois 60616
Principal Investigator: Patrick Corrigan, PsyD
Phone: 312-567-6751
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