The lives of adults with serious mental illness (SMI,
defined as mental, behavioral, or emotional disorders resulting in serious
functional impairment, e.g., major depression, bipolar disorder, schizophrenia)
are cut short by decades, mostly from heart disease (Chang et al., 2011; Colton & Manderscheid, 2006;
National Institute of Mental Health). People
with SMI are at higher risk for chronic illnesses including diabetes due to
their difficulty functioning in self-care, work and other social roles, with
additional cardiometabolic risk due to antipsychotics (Bahorik et al., 2017; Center for Behavioral Health
Statistics and Quality, 2015; Druss et al., 2011; De Hert et al., 2012; Donald C Goff et al., 2005; McEvoy
et al., 2005). Diabetes is 2-4X more
common in people with SMI, more so among minorities and young adults, and this
is only partly attributable to antipsychotic medication (Das-Munshi et al., 2017; D. C. Goff et al., 2005;
Mangurian et al., 2016; Mangurian et al., 2018). Georgia is 1/3 Black, with a high diabetes burden (12% diagnosed with
diabetes) (American Diabetes Association, 2024). Stigma about SMI contributes to health and social
disparities (Goldman et al., 2020; Goldman et al., 2018). Physical activity (PA) can reduce
cardiometabolic risk in people with SMI (J Firth et al., 2015; Rosenbaum et al., 2015;
Vancampfort et al., 2015; Ward et al., 2015).
Physical inactivity and prediabetes are more common in people with SMI (Mangurian et al., 2016; Mangurian et al., 2018).
Certified peer specialists (CPSs), trained
persons with lived experience in recovery from mental illness and/or addiction working
in mental health settings, include PA among their wellness goals (Druss et al., 2018; Druss et al., 2010). Mental health peers (people in recovery from mental
illness) in Georgia pioneered this line of work through the grassroots Georgia
Mental Health Consumer Network which oversees CPS training with support from
the Georgia State Department of Behavioral Health and Developmental
Disabilities, winning Medicaid reimbursement for CPS services (Chapman et al., 2015). Peer support programs are now part of reimbursable mental health
services in a majority of U.S. states (Kaufman, 2016). Evidence-based
exercise interventions for SMI populations incorporate CPSs, group exercise,
technology, and behavior change strategies (Druss et al., 2010; Caroline R Richardson et al., 2005;
Besenyi et al., 2022). Effective exercise treatment
delivery and sustainability remain challenging (Simon Rosenbaum et al., 2014; Wells et al., 2004). Innovative, scalable, evidence-based PA interventions
for people with SMI are urgently needed (McNamee et al., 2013).
Parks are free, ubiquitous spaces for PA. Parks
offer physical, psychological, and social benefits linked with improved health
behaviors and outcomes (Bedimo-Rung et al., 2005; Besenyi et al., 2014; Cohen
et al., 2013; Maas, van Dillen, et al., 2009). Studies, including ours, have related park access and use to greater
PA, mood, and quality of life (QOL), and less obesity, stress, morbidity and
mortality (Besenyi et al., 2015; Kaczynski & Henderson, 2007;
Kamel et al., 2014; Maas, Verheij, et al., 2009; van den Berg et al., 2010;
Villeneuve et al., 2012). Outdoor PA is
associated with increased enjoyment, satisfaction, and long-term PA adherence supporting
its use for behavior change, especially among those with SMI (Thompson Coon et al., 2011). Despite park-based PA benefits, few interventions
have been tested rigorously. None have focused on SMI populations (Wheeler et al., 2014).
Social cognitive theory (SCT) has been
successfully employed in exercise interventions with SMI (K. A. Aschbrenner et al., 2016; C. R. Richardson et
al., 2005). Briefly, SCT posits that
cognitive outcome expectations of health behavior, such as self-efficacy (e.g.,
belief that one is capable of changing behavior) and environmental factors,
such as social support and modeling influence the behavior (e.g., increasing
PA) (Bandura, 1986, 2004). This theory predicts that individuals high in self-efficacy will
execute behaviors more readily and with greater perseverance in response to initial
failure than individuals with lower self-efficacy, and that social supports
that encourage and facilitate the behavior will increase the likelihood of
behavior change and maintenance.
Purpose of the Present Study
Our long-term goal is to maximize the reach and
clinical impact of evidence-based exercise interventions to reduce
cardiometabolic risk among SMI populations through use of existing mental
health services and parks. The study aimed to pilot and develop an intervention
that could be scaled up in existing programs (Alegría et al., 2011; Kelly A Aschbrenner et al.,
2016; Heath et al., 2012). The PARCS Pilot
Study tested a 6-week exercise intervention (45 min CPS-led park-based exercise
3 days/week) vs. a waitlist control, as part of current mental health services.
Primary aims were feasibility and acceptability, with secondary aims to assess
preliminary effects on PA, aerobic fitness, and weight as indices of diabetes
risk. Exploratory measures included BMI, mood, and psychological mechanisms of
social cognitive theory (self-efficacy, social support) (Bandura, 1986, 2004). Qualitative observations and feedback from mental health professionals
were obtained.
Method
Sample
Initial
inclusion criteria were that participants were enrolled in the peer support
program (PEERS) at a community mental health center (CMHC) and therefore eligible
to participate in peer group activities, between 18 and 64 years of age, able
to act as their own legal guardian, and obtaining medical clearance by our
Safety Officer (JPM) after review of our health assessment, ACSM Risk
Stratification screening and a brief physical exam (Whitfield et al.,
2017).
Design
The
PARCS Pilot Study to
Reduce Diabetes Risk in Serious Mental Illness (ClinicalTrials.gov NCT05293587)
was the first randomized trial of a park-based exercise intervention as part of
current mental health services. Use of a public park exposed participants to
this community resource, to enhance knowledge and self-efficacy for exercise in
such a setting, as well as fitting in with the CMHC goal of community outings
for peers. This was an NIH-defined stage 1 project focused on the development
and refinement of the intervention, pilot and feasibility testing (National Institute
on Aging; Onken, 2022).
Informed consent was obtained in writing from each peer, and evaluation of
consent was conducted by a CMHC staff member to ensure understanding. The study
was approved by the CMHC’s Rights and Ethics Board, Georgia Department of Behavioral
Health and Developmental Disabilities Institutional Review Board (IRB), the
Georgia Department of Public Health IRB (190508), and the Augusta University
IRB (1434186). After surveys, baseline health assessment and medical clearance
(JPM) were obtained, peers were randomized 1:1 into park intervention or
waitlist groups using random digits in sealed sequentially numbered envelopes.
Intervention
A
6-week exercise intervention (45 min CPS-led park-based exercise 3 days/week) was
planned to include warmup, aerobic (walking), strength training (body weight
exercises), and cooldown activities, adapted for each participant’s level of
ability. Adaptations were made to intervention activities to permit peers with
physical limitations to participate fully (e.g., altered stance with one foot
forward, seated rather than standing, use of structures to support balance,
rest as needed). Research staff supported the CPS in leading the sessions
safely. As well, CPSs were offered training at no cost to be certified as Group
Fitness Instructors through the American Council on Exercise (ACE, San Diego
CA). Transportation to the park was provided by the CMHC using their existing
resources.
The
PEERS program implemented 2 sessions/week, rather than 3 due to programmatic
(other planned activities) and staffing limitations. To protect PEERS program
revenue, the transportation to and from the park sessions as well as the
intervention had to fit within a clock hour, along with a few minutes for the
CPS to prepare. If the peers came back after the top of the hour, they would not
be eligible for billing for the next PEERS group session.
Limitation of
Delivery
Sessions
were sometimes canceled or not held due to the CPS leader’s illness (4 times in 2021, 2
in 2022), staff training obligations (2 times in 2021), or other PEERS program
needs. For example, the CPS leader needed to stay on campus due to needing to
catch up after extended absence (once in 2021), peer crises that required the
CPS to stay on-site (once in 2021, 2 times in 2022), and a scheduled ACE Group
Fitness Instructor exam for the CPS leader (1 time in 2021). Two other
cancellations were due to a holiday when the PEERS program was closed and
weather (rain, 1 time). Make-up sessions were held and the intervention period
was extended to support intervention dose.
There
was 1 full-time and 1 part-time CPS and a vacant supervisor position at the
PEERS program during the 2021 intervention. In 2022 a full-time CPS supervisor
of the PEERS program (TS) was hired just before the intervention started, which
was helpful. The new supervisor facilitated problem-solving to avoid
cancellations, for example, altering her schedule to lead the peer group when
the part-time CPS was not available so that HB could lead a park session, and
providing policy guidance about when it was too cold or hot to exercise
outdoors. A mechanical problem with the van beginning at the first 2022 session
led to 2 sessions being held on the CMHC campus instead of at the park. This
way the exercise was at least out in nature. On another occasion, the CPS did
not feel well enough to drive so the session was held at the CMHC campus. A
borrowed minivan assigned to another CMHC program provided transportation to
the park during the 2022 cohort. Since then, a van has been consistently
available.
Measurements
Health assessment
At baseline and posttest, height was measured using a
portable stadiometer (Invicta Plastics Limited, Leicester England, IP 0955).
Body weight and composition were obtained at baseline and post using a
bioimpedance scale (Tanita DC 430U Dual Frequency Total Body Composition
Analyzer) or an electronic scale (A&D Precision Scale UC-321, Tokyo,
Japan). Resting seated heart rate and blood pressure was measured in duplicate
using a Dinamap machine at baseline and post and the lower measure recorded.
The 6-minute walk test (6MWT) was conducted using a 100-foot outdoor course in
a CMHC parking lot and recorded in feet (Crescent Lufkin FE100N, Apex Tool
Group LLC, Apex, NC). Adverse events were recorded and reviewed promptly by
Principal Investigator CLD and JPM, the safety officer for the trial.
Participants were given Fitbit Inspire 2 devices that
were to be worn every day to monitor daily steps. Fitbit accounts were set up
for each participant. We asked peers to always keep their Fitbit on regardless
of showering, swimming etc. and to charge them at PEERS rather than at home.
Peers were offered choices about color (white, black, pink) for the wristbands,
and replacement bands in case of damage. Fitabase (Small Steps Labs LLC, San
Diego, CA) was used to access Fitbit data. Steps
per day and wear time (percent of time per day the Fitbit heart rate
sensor is actively recording data) were
downloaded from Fitabase for analysis. To ensure valid data for analysis
without excluding too many, the Fitbit steps data were analyzed using 2
different minimum wear time thresholds: 50% and 80% per day. To be as inclusive
as possible, the selected minimum qualifying days was determined to be 3.
The
Fitbit Inspire2 devices were affordable, durable and reliable, with the longest
battery life among available Fitbit devices. One peer’s Fitbit survived a run through
the clothes washer and dryer. Unobtrusive syncing was feasible from outside the
room when peers were in group meetings. Fitbits and gift cards motivated peers
to enroll in the study. However, there were challenges. One peer carried his
Fitbit in his pocket instead of wearing it on his wrist, resulting in no valid
data according to wear time. Some peers complained that the band was
uncomfortable, who simply needed to loosen it one notch. Starting exercise mode
on Fitbits was
hindered by poor visibility of device screens outdoors. Setting the “Dim Screen” setting to off
did not fix this. Syncing challenges often required forgetting devices, turning
off Bluetooth and re-pairing Fitbits on staff devices (typically cell phones)
because few peers had smartphones. Google acquiring Fitbit in 2021 led to a change
in our login and syncing procedures. Several peers lost their Fitbits and/or
charging cables. Inconsistent Fitbit wear and charging by peers taught us to
encourage and incentivize consistently wearing the Fitbit. We used behavioral
contracting and clearer expectations at enrollment to promote wearing the
Fitbit, as well as social rewards (praise) and modeling (study staff and CPSs
wearing Fitbits) to encourage this. At first, PEERS staff kept Fitbit charging
devices in their offices because of theft concerns. We advised them that the study
could replace them as needed, and based on their advice, found charging devices
that were not as portable as the 11-inch charging cables that come with the
devices. PEERS staff decided to expect peers to charge their own Fitbits in the
PEERS meeting room to promote independence and reduce dependence on mental
health staff. We implemented a labeling system (mouse ear punch used to punch
the bands) to identify whose Fitbit is on the charger.
In
2022, after replacing lost Fitbits for a few peers, we had many requests for
replacement Fitbits. Loss may be due to cognitive difficulties, housing
instability, or lack of security (others in home). One peer’s romantic partner “borrowed” her Fitbit. One peer lost
2 Fitbits, possibly due to theft or sale. One peer requested a replacement when
she was wearing her Fitbit. After replacing several peers’ Fitbits, we limited
peers to one replacement device before they completed posttest. To avert these
requests, we implemented Tile, a mobile app to locate Fitbits when they are
lost. (Tile was installed by default on the Fitbit Inspire 2 devices.)
Surveys
At baseline and post-test, surveys were administered
by research staff. They were read aloud by the staff member or completed
independently by the peers as desired to accommodate possible literacy or
handwriting coordination challenges. Surveys included measures of PA
(International Physical Activity Questionnaire-Short Form (IPAQ-SF))(Craig et al.,
2003),
depressed mood (PHQ8) (Kroenke et al.,
2009)
and the Self-Efficacy for Exercise scale (Bandura, 2006;
Resnick & Jenkins, 2000; Wilcox et al., 2005). Higher scores on the PHQ-8 reflect
more severe depressive symptoms, and higher scores on the Self-Efficacy for
Exercise Scale indicate greater self-efficacy. A modified version of the Social
Support for Exercise scale (Sallis et al.,
1987)
was used to assess social support for exercise from CPSs and peers, instead of
family and friends. We omitted the optional Rewards and Punishments scale, and substituted
“today” for “tonight” in the reminders item (Sallis, 1996). A total of 10
items, rated 1-5 (none, rarely, a few times, often, very often) were summed for
both CPSs and peer support, with higher scores reflecting more support. The
Physical Activity Class Satisfaction Questionnaire (PACSQ) was administered to
peers after attending the park intervention, regardless of randomization (Cunningham, 2007). Seventeen items
were averaged on a scale of 1-8 where 1 indicates no satisfaction and 8
indicates fully satisfied. Two additional open-ended questions were, “What did
you enjoy the most (least) about park activity sessions?”
Qualitative data
Field notes recorded details of each park session,
reasons for cancellation, comments made by PEERS staff, and contextual
observations. After the intervention was complete, Structured
Assessment of Feasibility (SAFE) semi-structured interviews with CMHC staff
members were used to assess overall intervention acceptability and feasibility
within a mental health services framework (Bird et al., 2014). The SAFE measure
includes 16 items in three categories: intervention, resource consequences, and
evaluation. The SAFE measure has demonstrated excellent interrater and
test-retest reliability (0.84, 95% CI 0.79-0.89; 0.89, 95% CI 0.85-0.93
respectively). SAFE interviews were recorded, transcribed, and coded using
Dedoose version 9.0.17 (Los Angeles, CA). Three trained researchers coded each
interview. The data were analyzed using a thematic analysis.
Statistical
analysis
Descriptive and inferential statistics were computed
using SPSS and R after examining distributions and questionable values. Paired t-tests
or Mann-Whitney U tests compared changes from baseline to posttest between
intervention and waitlist control groups. The absolute value of Cohen’s d
effect size, which shows the magnitude in standard deviation units of difference
in changes between groups, was calculated for t-tests (Cohen, 1988).
Results
Feasibility
Twenty
peers were consented and 18 were randomized (6 to intervention, 12 to waitlist)
as shown in the flow diagram, Figure 1. Inclusion criteria were modified to
omit an upper age limit due to an otherwise eligible peer who was older than 64
years and fit enough to participate safely. We opted to be inclusive rather
than selective in our recruitment consistent with the Recovery Model and the
norms of the PEERS program (Peebles et al.,
2007; Substance Abuse and Mental Health Services Administration, 2012). There were no
differences in baseline characteristics by group (Table 1).
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