ACHIEVE-D Pilot Study
Phase: NA
Conditions: Obesity, Mental Disorders, Severe
Sponsor: Johns Hopkins University

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Adapted ACHIEVE
 
Curriculum
 
for
 
Community
 
Mental
 
Health Settings
NCT03999892
Protocol approval date 6/13/2019
Gail Daumit,
 
MD,
 
MHS

Date: May 15, 2019   
Principal Investigator: Gail Daumit 
Application Number: IRB00194122 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
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JHM IRB - eForm A – Protocol 
*************************************************************************************************** 
1.
Abstract
Prevalence of obesity is significantly elevated and a leading cause of preventable death in people
with serious mental illness (SMI) through its effects on other cardiovascular disease (CVD) risk
factors and CVD. Behavioral interventions targeting changes in diet and exercise need to be tailored
to the needs of people with SMI, such as memory impairment and limited executive function. The
NIMH-funded Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE) trial tested a
behavioral weight-loss intervention for persons with SMI and demonstrated clinically significant
weight loss. In light of the obesity epidemic in persons with SMI, there is an urgent need to scale-up
interventions like ACHIEVE. To increase ease of adoption and sustained implementation of
ACHIEVE in community mental health programs, the format needs to be adapted for delivery by
community mental health staff.  Based on our experience conducting the ACHIEVE trial, this study
team has already made modifications to adapt the ACHIEVE intervention into ACHIEVE-
Dissemination or “ACHIEVE-D” curriculum for community mental health settings. Therefore, we
will pilot test two months of this ACHIEVE-D curriculum in a community-based psychiatric
rehabilitation program (PRP) to determine whether this format is acceptable to participating PRP
consumers with SMI as well as PRP staff and peer leaders.
This pilot study protocol is the first part of an NIMH R34 study that will test strategies to increase
implementation of ACHIEVE. The second part of the R34 study, which will test the complete
version of ACHIEVE-D in multiple study sites, will be submitted as a change in research or a
separate protocol. This R34 is part of a P50, the NIMH Johns Hopkins ALACRITY Center.
2.
Objective
To pilot test two months of the adapted ACHIEVE-D curriculum at a single PRP.
Hypothesis 1: The adapted ACHIEVE-D curriculum will be acceptable to individuals with 
SMI.  
Hypothesis 2: The adapted ACHIEVE-D curriculum will be feasible and acceptable to PRP 
staff and peer leaders in promoting weight loss and lifestyle behavior change among 
consumers with SMI at their center. 
3.
Background
CVD and CVD Risk Factors among Persons with SMI. CVD is the leading cause of preventable
death among persons with SMI. Diet and physical activity habits are typically poor in this
population which contribute, along with metabolic side effects of many psychotropic medications,
to high rates of obesity, other CVD risk factors, and CVD. Behavioral interventions promoting
healthy diet, exercise, and weight loss are critically needed, but must be adapted to challenges
particularly to the SMI population including memory impairment, limited executive function, and
residual psychiatric symptoms.
The ACHIEVE Trial. The NIMH-funded ACHIEVE trial was the first to demonstrate that an
adapted behavioral intervention leads to clinically significant weight loss at 18 months among
persons with SMI (mean 7 lbs. weight loss, net 3% loss). The magnitude of weight loss among
individuals with SMI participating in ACHIEVE was similar to the magnitude observed in
efficacious weight-loss trials in general populations. The ACHIEVE intervention combined group

Date: May 15, 2019   
 
Principal Investigator: Gail Daumit 
Application Number: IRB00194122 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 3 of 13 
 
and individual weight-management sessions with group exercise sessions delivered in community 
mental health programs. The curriculum focused on repeated delivery of six key messages: avoid 
sugary drinks, avoid junk food, eat 5 servings of fruits/vegetables per day, portion control, smart 
snack habits, and regular physical activity. The ACHIEVE curriculum was predominantly delivered 
by trained study interventionists, though mental health program staff delivered some video-assisted 
group exercise sessions. In light of the obesity epidemic in persons with SMI, there is an urgent 
need to scale-up interventions like ACHIEVE. 
 
Considerations for Scaling up ACHIEVE. To realize the full public health potential of 
ACHIEVE, the curriculum needs to be modified for delivery by community mental health center 
staff.  Adaptations should ease implementation, but maintain fidelity to the core content of 
ACHIEVE (Table 1).  
Table 1.  ACHIEVE vs. ACHIEVE-D Comparison 
ACHIEVE Trial 
Proposed ACHIEVE-D Dissemination 
Type and Frequency of Contact  
Months 1-6: 
Group weight management class: 1x/wk, 45-min led by 
study interventionist; Individual weight management visit: 
1x/month, 15-20 min with interventionist; Group exercise 
classes: 3x/week, 50-min led by interventionist. PRP staff 
delivered video-assisted classes 1x/wk in mo. 6-12, 2x/wk in 
mo. 13-18. 
Months 1-6: 
Multipurpose class: group weight management + 
exercise: 3x/wk, 45 to 60-min class (~20-30 min weight 
mgmt, ~20-30 min exercise) led by a PRP staff member and 
peer leader trained as ACHIEVE-D coach/peer-leader.  
Weigh-ins: weekly, 2 min 
Weigh-ins: weekly, 2 min 
Curriculum Delivery Modality 
Weight mgmt: In-person  
Exercise: Staff led or video-assisted 
Weight mgmt: In-person with short videos  
Exercise: Video-assisted 
Goals and Recommendations 
Weight loss goal 10lbs in 18 mo. (tailored to indiv.) 
Weight loss goal 5lbs in 6 mo. (tailored to indiv.) 
Behavioral Recommendations: 6 messages 
Behavioral Recommendations: 6 messages 
Modifications to the curriculum delivery and schedule – e.g. video-assisted, combined exercise and 
weight management sessions-could help support efficient, staff-led delivery. However, whether 
these adaptations will produce similar behavior change results have not yet been tested. Based on 
their experience conducting the ACHIEVE trial, the study team is making these modifications to 
adapt the ACHIEVE intervention into the ACHIEVE-Dissemination or “ACHIEVE-D” curriculum 
for community mental health settings. The curriculum adaptations are described in more detail 
below: 
(1) Class Format: Group weight management and exercise will be combined into one multi-
purpose class in ACHIEVE-D. To increase efficiency of delivery, ACHIEVE-D will be 
conducted in group sessions only; in lieu of the individual weight management sessions used in 
ACHIEVE, coaches and peers will be encouraged to set individualized behavioral goals related 
to the topic of the week during the discussion portion of group sessions.  
 
(2) Class Timing: ACHIEVE-D multi-purpose classes will be held three times a week; this 
schedule will make it easier for consumers to receive the curriculum if they miss one of the 
groups, eliminating the need for make-up sessions.  Within each monthly module (Table 2), 
topic varies by week. In the three group weight management + exercise classes each week, 
content builds gradually but is largely repeated; repetition of messages is a key tenet of 
intervention tailoring for SMI. This format will also provide frequent opportunities for on-site 
exercise.   

Date: May 15, 2019   
 
Principal Investigator: Gail Daumit 
Application Number: IRB00194122 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
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Table 2. ACHIEVE-D Monthly Modules (and Example Weekly Topics)  
Weight Loss Success (e.g., What Does it Mean to Watch What You Eat?) 
Avoiding Sugar Drinks (e.g., Drinking Enough Water) 
Avoiding Junk Food  (e.g., Avoiding Junk Food by Making Smart Choices) 
Eat more Fruits and Vegetables (e.g., Adding Fruits & Veg to Your Meals) 
Eat Smart Portions (e.g., Slowing Down for Smart Portions) 
Smart Snacking (e.g., Creating Smart Snack Habits) 
 
(3) Video-Assisted Content: In the ACHIEVE trial, mental health program staff used videos to 
successfully deliver exercise classes; we will use the same exercise video approach in 
ACHIEVE-D. In addition, we have developed weight-loss content videos for each week of the 
curriculum. Each 5 to10-minute video segment will assist coaches and peer leaders in delivering 
the evidenced-based weight management content (e.g., video showing consumers reviewing the 
calorie and sugar content in various beverages). In class, the coach will introduce the weight 
management topic using the video, followed by discussion.  Coaches will stop and start videos 
as-needed, emphasize repetition of content, and use motivational interviewing techniques to 
evoke consumers’ confidence and competence to implement each ACHIEVE-D behavior.   
 
(4) Peer Leaders: In ACHIEVE-D, peer leaders will support ACHIEVE-D coaches in 
curriculum delivery.  Specifically, peers will role-model behaviors for the entire group, 
particularly during the group exercise sessions; help participants with SMI set realistic 
individualized behavioral goals; and encourage consumers’ with SMI to consistently attend 
class. Because of their common SMI experience, peers are in a unique position to demonstrate 
empathy and support consumers in behavior change.  
 
In this study, we will pilot test two months of the ACHIEVE-D curriculum in a community-based 
psychiatric rehabilitation program (PRP) to determine whether this format is acceptable to 
participating PRP consumers. The study team has prior experience collecting qualitative and 
quantitative data and delivering interventions among persons with SMI and has a long-term 
relationship with the study site (Prologue, Inc.) where this research will be conducted. 
 
4. 
Study Procedures 
a. Study design  
We will conduct a pre/post study of two months (8 weeks) of the ACHIEVE-D curriculum. We 
will conduct a focus group among mental health consumers, as well as secondarily compare 
their outcomes pre- and post- intervention. The study will invite PRP staff as well as peer 
leaders to observe all the sessions during this pilot. We will conduct a focus group among PRP 
staff and peer leaders who observe the intervention sessions. Our primary outcomes will be to 
determine the acceptability and feasibility of the adapted curriculum.  
 
Description of ACHIEVE-D Intervention 
We will test two modules of the adapted video-assisted curriculum format (Tables 1 & 2). 
Consumers will participate in 45 to 60-minute multipurpose classes three times per week, which 
will include a segment on group weight management (~20-30 minutes) and group exercise (~20-
30 minutes). Within each module, the group weight management topic varies by week, and 
within each week the content of the three weight management groups builds gradually and is 
purposely repeated. Within each module, the group exercise classes will focus on mild to 
moderate intensity aerobic exercise using an exercise video. The class will have a progression of 

Date: May 15, 2019   
 
Principal Investigator: Gail Daumit 
Application Number: IRB00194122 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
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intensity and duration appropriate for sedentary individuals. Classes will start at a lower 
intensity for 10-15 minutes and gradually progress to moderate intensity aerobic exercise for 20-
30 minutes per session across the two-month period. Participants will also be encouraged to 
engage in moderate intensity exercise, such as brisk walking, of similar duration on days when 
they are not at the PRP. In this pilot study, a trained study interventionist will deliver the 
ACHIEVE-D curriculum, as our aim is to determine acceptability of this new format with 
consumers, PRP staff and peer leaders prior to training the PRP staff and peer leaders to deliver 
the content, which is planned for a subsequent study. 
 
Procedures related to Hypothesis 1 – Consumers with SMI 
Recruitment. We will recruit participants from Prologue, which is a PRP based in Baltimore 
with whom the study team has a long-term relationship (see letter of support). We will use 
similar methods as in prior and ongoing studies. We will recruit consumers with SMI who are 
willing to participate and have no contraindications to participating in a diet and physical 
activity program (see eligibility criteria described in following section).  
 
We will make presentations during regular consumer meetings at the PRP where we will 
provide information about the study. We will also display recruitment flyers in the PRP (Flyer). 
We will use a telephone script to handle all calls or in-person inquiries generated from these 
presentations and flyers (Screening Script). Consumers who are interested in participating will 
sign up to attend a consent/screening visit.  To address privacy issues during recruitment, all 
participants who are contacted or who approach us for recruitment will be assured that the 
research staff at Johns Hopkins will be the only ones to see their information, and that the 
information we collected will be kept private and be used only for the research study we are 
discussing. If the potential participant chooses not to enroll in the study or does not qualify to be 
in the study, then his/her information will be destroyed.  
 
Consent & Screening. We plan to screen a total of 20 consumers with the goal of enrolling 
approximately 10 into the study. Participant eligibility will be determined at the 
consent/screening interview (Table 3). 
 
Consent 
The study will be explained in detail to the potential participants in a one-on-one format onsite 
at the PRP in a private room. Informed consent for the study will be obtained from each eligible 
participant at the beginning of this visit (Consumer Written Consent). In particular, consumers 
will be advised of the voluntary and confidential nature of participation. Consumers will be 
asked questions about the study procedures to test their understanding. They will also be 
provided the contact information of the principal investigator. We will emphasize that their 
participation in the study will not affect their care at the PRP or Johns Hopkins. After consent is 
obtained, then potential participants will be screened.   
 
Screening 
The consumer will meet individually with a research staff member onsite at the PRP in a private 
room. Basic demographics will be assessed. A brief medical history will be taken and the 2018 
Physical Activity Readiness Questionnaire+ (2018 PAR-Q+) will be administered as part of the 
exercise pre-participation health screening.  Consumers will give permission for their primary 
care physicians to be contacted regarding medical eligibility for participation in moderate 
exercise and for review of Prologue on-site medical records. We will assess for alcohol and 
illicit substance use. Height and weight will be measured using standard procedures. We will 

Date: May 15, 2019   
 
Principal Investigator: Gail Daumit 
Application Number: IRB00194122 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 6 of 13 
 
measure weight to the nearest 0.1 lb by a high quality digital scale with participants wearing 
light indoor clothes without shoes. Weight will be measured in lbs for ease of interpretation by 
participants and converted to kg for calculation of BMI.  The scale will be calibrated quarterly 
using standard weights by trained study personnel. Height, without shoes, is measured once at 
baseline using a wall-mounted stadiometer. Body mass index is calculated as the Quetelet index 
(kg/m2). Consumers who meet all eligibility criteria (see eligibility criteria described in 
following section) will be enrolled into the pilot study.  
 
Primary Outcome – Consumer Focus Group Procedures. At the end of the preliminary pilot 
period, we will conduct one 90-minute focus group with consumers. The focus group will assess 
consumers’ satisfaction, perceptions and attitudes regarding the ACHIEVE-D program. We will 
inquire with them regarding their satisfaction with the curriculum, including seeking feedback 
on feasibility of format, understandability of content, and likability of intervention materials, as 
well as challenges/issues that they experienced. We will also discuss whether members were 
successful in making diet and physical activity changes, as well as barriers and facilitators to 
making the change. This focus group will be held in a private room in the PRP. We will use a 
moderator guide for the focus group (Consumer Focus Group Moderator Guide). The group will 
be tape-recorded and conducted by a moderator. The focus groups will be transcribed by 
Production Transcripts. 
 
Secondary & Other Outcomes – Survey, Anthropometric and Process Measure 
Procedures. This data will be collected during study visits at baseline and follow-up for 
enrolled particpants held onsite at the PRP in a private room. Surveys will be administered in-
person by trained research assistants. All data will be collected on Johns Hopkins encrypted, 
password protected laptop computers and entered into a RedCap database. Because of 
consumers’ generally low literacy and problems with cognition, all instruments will be 
interviewer administered to decrease the burden on participants and improve validity of data 
collection. Enrolled participants will complete baseline data collection measures (Table 3). 
 
During the intervention, we will also collect data on participants regarding attendance, weight 
from weigh-ins during the sessions, hours per week each consumer participated in ACHIEVE-D 
exercise classes, as well as diet and physical activity via weekly self-reported logs.  
 
We will video record each class session (3 classes per week for 8 weeks – 24 sessions total) and 
grade the sessions using a fidelity tool (ACHIEVE-D Fidelity Tool), which measures to what 
extent the coach implements the core components of ACHIEVE-D and uses a motivational 
interviewing delivery style. Once videos are evaluated for fidelity, any that are not needed will 
be destroyed; some will be stored on a Johns Hopkins secure network drive and used for future 
training in fidelity monitoring. In addition, short video clips from these sessions may be 
incorporated into materials for the larger R34 study including to train coaches. 
 
 
After completion of the intervention, consumers will complete a survey including asking 
questions regarding satisfaction with the curriculum, self-reported sugar sweetened beverages 
and sedentary behaviors, and anthropometric measurements will be repeated at this time. We 
will also repeat other measures as described in Table 3. 

Date: May 15, 2019   
 
Principal Investigator: Gail Daumit 
Application Number: IRB00194122 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 7 of 13 
 
 
Table 3. Data Collection Schedule 
Consent/ 
Screening 
Baseline 
Follow-up 
During 
Post 
Informed consent 
x 
 
 
 
Demographics 
x 
 
 
 
Medical history 
x 
 
 
 
Medications 
x 
 
 
x 
Substance use (ASI-Lite) 
x 
 
 
 
Exercise pre-participation screening (2018 PAR-Q+) 
x 
 
 
 
Weight 
x 
x 
x 
x 
Height 
x 
 
 
x 
Primary Outcomes 
 
 
 
 
Consumer focus group 
 
 
 
x 
PRP staff & peer leader focus group 
 
 
 
x 
Secondary Outcomes 
 
 
 
 
Diet 
 
 
 
 
EARLY Eating Away from Home Q 
 
x 
 
x 
EARLY SSB Consumption Q 
 
x 
 
x 
Physical Activity 
 
 
 
 
CARDIA/EARLY Q – sedentary behavior 
 
x 
 
x 
Eating Behaviors 
 
 
 
 
Palatable Eating Motives Scale (PEMS) – Coping Subscale 
 
x 
 
x 
Trait Food Craving Q – Reduced Form 
 
x 
 
x 
Reward-based Eating Drive (RED) Scale 
 
x 
 
x 
Psychological & Support 
 
 
 
 
Perceived Stress Scale (PSS) 
 
x 
 
x 
Important Others’ Q 
 
x 
 
x 
Anthropometric Measurements 
 
 
 
 
Waist circumference 
 
x 
 
x 
Process Measures 
 
 
 
 
Consumer attendance & exercise at group sessions 
 
 
x 
 
Consumer food and physical activity logs 
 
 
x 
 
Consumer Satisfaction Q - Nabati 
 
 
 
x 
Coach Fidelity to ACHIEVE-D 
 
 
x 
 
Abbreviations: SSB – sugar-sweetened beverage; Q – questionnaire 
 
Below we describe the planned secondary outcomes: 
Acceptability 
A 12-item Consumer Satisfaction Questionnaire based on the instrument developed by Nabati 
and colleagues will be used to determine acceptability. Following the intervention, in addition to 
the focus group, we will use this standard measure of satisfaction with the intervention. We will 
also examine participation as a reflection of acceptability. Participation in intervention sessions 
will be measured by attendance at the group classes, the number of sessions attended, and 
proportion attending at least 80% of sessions.    
 

Date: May 15, 2019   
 
Principal Investigator: Gail Daumit 
Application Number: IRB00194122 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 8 of 13 
 
Diet 
We will administer the EARLY Sugar-Sweetened Beverage (SSB) questionnaire at baseline and 
post-intervention, which has been selected by the NIH as Accumulating Data to Optimally 
Predict Obesity Treatment (ADOPT) Core Measures for diet.  
 
Physical Activity 
We will administer the sedentary behavior inventory from CARDIA/EARLY at baseline and 
post-intervention, which has been selected by the NIH as ADOPT Core Measures for self-
reported physical activity. 
 
Weight & Waist Circumference 
Weight will be measured at baseline and post-intervention using standard procedures as 
described in the screening section above. Waist circumference is measured using a tape, 
according to a standardized protocol at baseline and post-intervention. 
 
Below we describe the other planned survey measures in this study: 
Demographics 
Most demographic data will be obtained from Prologue’s intake assessment, but we will obtain 
updated marital status and living arrangements as well as confirm educational level. This data 
will be collected at the screening visit. 
 
Medical History 
We will measure medical conditions with a short checklist of conditions. Each consumer is 
required to have a physical exam annually, and a list of medical conditions is kept in the 
Prologue chart. Potential participants will consent to allow us to review their medical records at 
Prologue.  We will assess conditions by reviewing the medical chart and by interview. Any 
discrepancies will be confirmed by participants’ primary care physicians. This data will be 
collected during screening. 
 
Medications  
Prologue tracks all medications and medication changes.  We will measure medications 
including dose, route and frequency at baseline by compiling a list of medications from the 
medical chart.  Potential participants will be asked to confirm this list with input from 
caregivers, as needed.  Medication information will be updated at the end of the pilot 
intervention.  
 
Diet and Eating Habits  
We will administer the EARLY Eating Away from Home questionnaire and 3 questionnaires 
regarding eating habits as listed in Table 3, which have been selected by the NIH as ADOPT 
Core Measures for these domains. 
 
Psychological & Support  
We will administer 2 questionnaires regarding psychological and social support domains as 
listed in Table 3, which have been selected by the NIH as ADOPT Core Measures for this area. 
 
 
Procedures related to Hypothesis 2 – PRP staff and peer leaders 

Date: May 15, 2019   
 
Principal Investigator: Gail Daumit 
Application Number: IRB00194122 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 9 of 13 
 
We will recruit staff and peer leaders from Prologue, who will be invited to observe all the 
sessions during this pilot. We aim to recruit at least 4 PRP staff members and at least 1 peer 
leader to observe however, we have the capacity for up to 20 staff or peers.  
 
At the end of the pilot period, we will conduct a 90-minute focus group with PRP staff and peer 
leaders who were able to observe at least two sessions of the ACHIEVE-D curriculum to 
explore their perceived feasibility of delivering such a program as well as their satisfaction with 
program content and format. Informed consent will be obtained from each participant on the day 
of the focus group (Staff & Peer Leader Oral Consent). We will use a private room in the PRP 
for this group. We use a moderator guide for the focus group (Staff & Peer Leader Focus Group 
Moderator Guide), and will show them video recorded of the pilot intervention session(s) to 
facilitate the discussion and prompt feedback. The focus group will be tape-recorded and 
conducted by a moderator. The focus groups will be transcribed by Production Transcripts. 
Names will be removed from transcripts and replaced with ID numbers. After transcription, 
recordings will be destroyed. 
 
b. Study duration and number of study visits required of research participants. 
We anticipate that the total duration for all study procedures to be 4 months, and the 
intervention will take 2 months. Consumers will participate in a focus group as well as complete 
baseline and post-intervention data collection visits. PRP staff and peer leaders will participate 
in a focus group. Study visits and focus groups will be held onsite at the PRP. 
 
c. Blinding 
Not applicable 
 
d. Justification of why participants will not receive routine care or will have current therapy 
stopped. 
Not applicable 
 
e. Justification for inclusion of a placebo or non-treatment group. 
Not applicable 
 
f. Definition of treatment failure or participant removal criteria. 
Not applicable 
 
g. Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely. 
Not applicable 
 
5. 
Inclusion/Exclusion Criteria 
For consumers with SMI to participate in the pilot, they must be aged 18 and older and are 
consumers at Prologue psychiatric rehabilitation program. In addition, we will require that these 
consumers are 1) Expected to be in the rehabilitation program for at least 6 months after enrollment 
in intervention and able to attend the intervention classes 3 days per week, 2) Able and willing to 
give informed consent and participate in the intervention, 3) have a BMI over 25 kg/m2 (overweight 
or greater), and 4) be interested in losing weight. 
 
We will exclude consumers with any underlying medical conditions that could seriously reduce 
their life expectancy, their ability to participate in the study, or for which dietary change or physical 

Date: May 15, 2019   
 
Principal Investigator: Gail Daumit 
Application Number: IRB00194122 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 10 of 13 
 
activity may be contraindicated and/or require medical supervision by a physician such as 
medication-dependent diabetes mellitus, cancer or malignant tumor, lung disease requiring 
supplemental oxygen, dementia or cognitive impairment, consumption of more than 14 drinks per 
week, eating disorders, angina, or diagnosis in the last 12 months of myocardial infarction, 
congestive heart failure, transient ischemic attack or stroke, liver disease or kidney disease. We will 
exclude women who are pregnant or breastfeeding. We will also exclude individuals with an 
inability to walk to participate in exercise class as demonstrated by walking up and down 2 flights 
of stairs.  
 
We will follow the American College of Sports Medicine (ACSM) recommendations for health 
screening and risk stratification in preparation for starting a moderate intensity exercise program. 
The ACSM exercise pre-participation health screening process focuses on 1) the individual’s 
current level of physical activity, 2) presence of signs or symptoms of known cardiovascular, 
metabolic, or renal disease, and 3) the desired exercise intensity, as these variables have been 
identified as risk modulators of exercise-related cardiovascular events. The intervention emphasizes 
the achievement of moderate, not vigorous intensity physical activity; the safety of moderate 
intensity physical activity in properly screened subjects is well established.   
 
The 2018 Physical Activity Readiness Questionnaire (2018 PAR-Q+) will be administered to triage 
participants within the ACSM Exercise Pre-Participation Health Screening Logic Model.  For 
persons who require medical clearance according to these ACSM guidelines, we will refer them to 
their physician and send a letter to this physician informing them that the patient is planning on 
enrolling in the study (Physician Approval for Exercise Letter). We will ask for a fax-back form 
with medical clearance from the physician for the individual to participate. The ACSM guidelines 
define medical clearance as approval from a health care professional to engage in exercise, on the 
basis of the presence of signs or symptoms and/or known cardiovascular, metabolic, or renal disease 
and physical activity status. The term ‘‘medical clearance’’ has replaced specific recommendations 
for a medical examination or exercise test because it should be the health care provider who decides 
what evaluation, if any, is appropriate before the initiation of a moderate-intensity exercise program 
as proposed in ACHIEVE-D. 
 
For PRP staff or peer leaders to participate, they must be at least 18 years old and have observed at 
least two ACHIEVE-D sessions. 
 
6. 
Drugs/ Substances/ Devices 
Not applicable  
 
7. 
Study Statistics 
a. Primary outcome variables. 
All focus groups will be audio recorded and transcribed verbatim. Research assistants will check the 
transcripts for accuracy. Two investigators will identify meaningful segments within the responses 
and assign codes using an editing style analysis technique for each focus group transcript. We will 
group codes into themes and discuss these themes among the entire team of investigators. We will 
use Atlas.ti 5.2 software to facilitate qualitative data management and analysis. The study team will 
also review the transcripts and make modifications to the intervention materials and study 
procedures for a future trial based on these results. 
 
b. Secondary outcome variables. 

Date: May 15, 2019   
 
Principal Investigator: Gail Daumit 
Application Number: IRB00194122 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 11 of 13 
 
We will conduct descriptive analyses of baseline data. Our acceptability outcomes among 
consumers will include their satisfaction with the intervention as well as program attendance. Our 
behavior change outcomes among consumers will include changes in dietary and physical activity 
measures pre-post. We will examine changes in diet and physical activity outcomes with t-tests and 
Chi Square tests, as appropriate. If these outcomes are not normally distributed, then we will use 
Wilcoxon signed-rank tests in lieu of t-tests. 
 
c. Statistical plan including sample size justification and interim data analysis. 
Not applicable to qualitative data collection 
 
d. Early stopping rules. 
Not applicable 
 
8. 
Risks 
a. Medical risks, listing all procedures, their major and minor risks and expected frequency. 
ACHIEVE-D Intervention Risks.  
 
The 2 month behavioral weight loss intervention sessions should be minimal risk for participants.  
Physical activity may pose a small risk of musculoskeletal injury. In addition, making dietary 
changes and engaging in moderate-intensity exercise may also pose risks such as needing to adjust 
the dose of certain medications (e.g., hypoglycemic agents) or may be inappropriate for people with 
certain medical conditions. 
 
Focus Group Risks. This study involves focus group discussion. Every effort will be made to 
protect confidentiality. There is minimal risk to the participant. If a participant changes her/his mind 
and does not wish to complete the focus group discussion, s/he will be allowed to leave.  
 
Data Collection Risks. Risks related to the data collection include loss of confidentiality, and 
potential discomfort, boredom or inconvenience from participating in a focus group and answering 
survey questions and undergoing anthropometric measurements.  
 
b. Steps taken to minimize the risks. 
Minimizing ACHIEVE-D Intervention Risks.  
Participant safety will be closely monitored.  Protection of research participants begins with the 
eligibility criteria, which are designed to exclude individuals with a serious medical condition that 
would preclude their ability to lose weight or to exercise safely.  This will be done in collaboration 
with the participant’s primary care physician.  During the study, clinical care will be provided by 
the participants’ usual specialty mental health providers and the primary care physician, not by the 
study.  Participants will be made aware of this delineation of responsibility. We will carefully 
monitor the safety of enrolled participants. Participants will be educated about symptoms to look for 
(e.g., low blood sugar). If a participant develops a medical problem, the safety of continuing or 
resuming the intervention will be ascertained by the participant’s primary care physician in 
collaboration with a study clinician.   
 
Consumers will be screened for orthopedic or rheumatologic problems that might limit their ability 
to participate in the physical activity component of the intervention. Exercise classes will focus on 
mild to moderate intensity aerobic exercise using progression of intensity and duration appropriate 
for sedentary individuals. Staff will be trained to identify signs and symptoms of cardiovascular 
events in accordance with CPR training. In the case of illness or injuries during the intervention 
period (e.g., motor vehicle accident), interventionists continue to advise consumers on adapting 

Date: May 15, 2019   
 
Principal Investigator: Gail Daumit 
Application Number: IRB00194122 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 12 of 13 
 
their physical activity program.  If there is any question about the etiology of an injury or the need 
for treatment, the consumer will be referred to a physician for further evaluation. 
 
 
 
Minimizing Focus Group Risks. We will minimize risk of group discussions by advising 
participants that by agreeing to be in this study, they are agreeing not to talk about any personal 
details that other individuals share in the focus group. Participants will be informed that they do not 
have to participate in any group discussion where they feel uncomfortable and can leave the session 
at any time. 
 
Minimizing Data Collection Risks. There is a risk of the loss of confidentiality of medical 
information. We will ensure protection of the data and any personal health information. Only the 
study team will have access to participant’s identifying information. Each participant will be 
assigned an identification (ID) number at the time of recruitment. The database that links the ID 
with the participant will only be accessible by the principal investigator and core investigative team. 
Data will be stored in RedCap and when exported on a Hopkins (JHMCIS managed) network drive  
which is password- protected and backed-up each night. If a participant changes her/his mind and 
does not wish to complete the study s/he may withdraw at any point.  
 
Participants will be aware through the consent process that videos will be taken of the group 
sessions and that clips may be incorporated into future training materials or posted on Dr. Daumit’s 
research website.  
 
 
There is a risk of potential stress, discomfort, boredom or inconvenience from answering survey 
questions and undergoing anthropometric measurements. Participants will be informed that they do 
not have to answer any questions that they do not wish or have their waist circumference, height, or 
weight measured. There are risks related to interview location at the PRP. To ensure participants’ 
privacy, we will conduct interviews in a private space.  
 
 
c. Plan for reporting unanticipated problems or study deviations. 
Unanticipated problems or study deviations will be reported to the IRB, the NIH, and if applicable 
to all study participants in a letter. 
 
d. Legal risks such as the risks that would be associated with breach of confidentiality. 
None 
 
e. Financial risks to the participants. 
None 
 
9. 
Benefits 
Consumers may benefit from participating to increase their knowledge about healthy diet and 
physical activity. This study may provide benefit to society at-large, as our results will help us 
determine whether the ACHIEVE-D curriculum is acceptable to consumers with SMI. We believe 
that the risks to subjects are minimal and reasonable given the knowledge to be gained.  There are 
no direct benefits to the PRP staff or peer leaders; however, their input is likely to improve the 
design and implementation of the ACHIEVE-D curriculum in a future trial.  

Date: May 15, 2019   
 
Principal Investigator: Gail Daumit 
Application Number: IRB00194122 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 13 of 13 
 
 
10. 
Payment and Remuneration 
We will offer all consumers an incentive to complete the screening ($10), baseline ($20) and follow 
up assessment ($30), as well as an incentive to participate in the focus group ($25). Total possible 
compensation for data collection for consumers is $85. PRP staff and peer leaders who participate 
in the focus group session will receive a $25 at the conclusion of the session to compensate for their 
time 
 
11. 
Costs 
There are no costs to participants.