Adapting an Evidenced-based Weight Management Intervention and Testing Strategies to Increase Implementation in Community Mental Health Programs
Phase: NA
Conditions: Overweight and Obesity
Sponsor: Johns Hopkins University

 
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Adapting an Evidenced-based Weight Management Intervention and Testing Strategies to Increase 
Implementation in Community Mental Health Programs 
 
 
January 8, 2025 
NCT03454997 
 

 
2 
 
 
 
 
STUDY PROTOCOL 
 
STRATEGIES TO INCREASE IMPLEMENTATION OF AN ADAPTED, EVIDENCE-BASED WEIGHT 
MANAGEMENT INTERVENTION IN COMMUNITY MENTAL HEALTH PROGRAMS: THE ACHIEVE 
IMPLEMENTATION AND DISSEMINATION PILOT TRIAL  
 
IRB00247344 January 8, 2025 
 
Version 1.0 – February 23, 2021  
 
Version 1.4 1.8.2025 
• 
Change in PI to Gail Daumit, MD, MHS due to original PI leaving JHSOM. 
 
Changes from version 1.3-10.18.2022 
• 
Adding interviews six-month post project completion for staff coaches and administration 
• 
Adding in $25 for both completion of focus group and for a six-month post project interview for coaches 
and peer leaders 
• 
Adding in $25 for completion of focus group for other staff  
 
Changes from version 1.2-March 8, 2022 
• 
Adding Perceived Usefulness (motivational interviewing avatar platform) survey to coach participant 
six-month follow-up data collection 
 
Changes from version 1.1- December 13, 2021 
• 
Added Avatar Motivational Interviewing (MI) satisfaction survey to the coach participant six month 
follow-up data collection 
 
Changes from version 1.0 
 
Version 1.1- September 23, 2021 
 
• 
Modified consumer participants eligibility criteria for BMI from ≥30 kg/m2 to ≥25 kg/m2 
• 
Increased flexibility of program delivery by changing the number of groups offered each week from 3 
groups/week to a minimum of one group/week 
• 
Modified the curriculum to allow for the inclusion of group exercise during in-person groups, if permitted 
by the sites’ COVID-19 safety protocols 
• 
Modified the curriculum to allow for virtual exercise groups facilitated by a trained peer leader and study 
team 
 
 
 

 
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                                                              Table of Contents 
 
1.   ABSTRACT ............................................................................................................................  
 
2.   SPECIFIC AIMS .....................................................................................................................  
 
3.   BACKGROUND & SIGNIFICANCE .......................................................................................  
 
4.   DESIGN SUMMARY………………………………………………………………………………… 
 
5.   SITE ELIGIBILITY  .................................................................................................................  
 
6.  STUDY POPULATION: COACHES AND PEER LEADERS ...................................................  
         
6.1 Eligibility criteria..….……………………………………………………........................... 
6.2 Data collection procedures……………………………………………………………….. 
6.3 Measurements…………………………………………………………………………….. 
 
7.  STUDY POPULATION: CONSUMER PARTICIPANTS  .........................................................  
         
7.1 Eligibility criteria..….…………………………………………………….......................... 
7.2 Data collection procedures ………………………………………………………………. 
7.3 Measurements …………………………………………………………………………….. 
 
8.  STUDY POPULATION: OTHER STAFF .................................................................................  
         
8.1 Eligibility criteria..….……………………………………………………........................... 
8.2 Data collection procedures ………………………………………………………………. 
8.3 Measurements …………………………………………………………………………….. 
 
9.    QUALITY ASSURANCE AND QUALITY CONTROL ……………………………………….. 
    
10.  RANDOMIZATION AND BLINDING......................................................................................  
 
11.  INTERVENTION GROUPS ....................................................................................................  
 
12.  DATA MANAGEMENT AND SECURITY  .............................................................................  
 
13.  DATA ANALYSIS..................................................................................................................  
 
14.  HUMAN SUBJECTS .............................................................................................................  
 
15.  POTENTIAL RISKS ..............................................................................................................  
  
16.  ADEQUACY OF PROTECTION AGAINST RISKS  ..............................................................  
 
17.  BENEFITS .............................................................................................................................  
 
18. REFERENCES .......................................................................................................................  
 
 
 

 
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1. ABSTRACT 
Prevalence of obesity is significantly elevated in people with serious mental illness (SMI)1-3, and obesity is a 
leading cause of preventable death in this population directly through its effects on cardiovascular disease 
(CVD) and indirectly by contributing other CVD risk factors4-10. In general populations, behavioral weight-loss 
interventions have been demonstrated to improve CVD risk by reducing blood pressure and glucose, as well 
as improving lipid profiles11. However, behavioral interventions targeting changes in diet, exercise and weight 
loss need to be tailored to the particular needs of people with SMI, such as memory impairment and limited 
executive function12,13.  
The NIMH-funded Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE) trial tested a 
behavioral weight-loss intervention for consumers with SMI who attended community-based psychiatric 
rehabilitation programs14. This randomized controlled trial (RCT) demonstrated clinically significant weight loss 
(mean 7 lbs. at 18 months)15. ACHIEVE included group and individual weight-management and group exercise 
sessions, which was led by trained study interventionists. Given the obesity epidemic in persons with SMI, 
there is an urgent need to “scale-up” or expand ACHIEVE to similar settings and populations as those included 
in the RCT, which we posited could be accomplished by enabling the psychiatric rehabilitation program staff to 
deliver the sessions16. Using the Enhanced Replicating Effective Programs Framework for translating 
evidence-based interventions into community settings17, our scale-up strategy considers this model’s three 
stages: pre-implementation, implementation, and dissemination.   
As part of the pre-implementation stage, we adapted the format of the original intervention to increase ease of 
adoption and sustained implementation of ACHIEVE by program staff in these community-based programs. 
(IRB00194122). We retained the core components, but modified the curriculum schedule (e.g., combined 
exercise and weight management group sessions) and enhanced the delivery format (e.g., video-assisted 
content) to support efficient, staff-led delivery. We pilot tested this adapted curriculum (ACHIEVE-D) where a 
trained study interventionist implemented 2 months of programming at a community-based psychiatric 
rehabilitation program18, and we then further refined the adapted curriculum based on feedback from program 
staff and participating individuals with SMI.  
 
In the implementation stage, the objective of this study is to develop and test innovative interventions to give 
community-based psychiatric rehabilitation program staff the knowledge, self-efficacy, and skills to deliver the 
adapted ACHIEVE curriculum (ACHIEVE-D) with high fidelity. Training of the ACHIEVE study interventionists 
required significant in-person initial and ongoing training, as well as performance feedback with particular 
emphasis on motivational interviewing skills14,15. Time and other logistical constraints prevent community-
based psychiatric rehabilitation program staff from participating in such intensive training. By leveraging novel 
strategies that incorporate advances in training and feedback modalities (e.g., online training, virtual training 
environments), staff training could facilitate adoption and sustained implementation of the ACHIEVE 
curriculum. To prepare for dissemination, we will also determine the acceptability, appropriateness, and 
feasibility of both the ACHIEVE-D curriculum and the standard and enhanced strategies among coaches and 
program directors to direct further refinements of these products. 
Strategies to increase implementation of an adapted, evidence-based weight management intervention in 
community mental health programs: The ACHIEVE Implementation and Dissemination Pilot Trial is an RCT 
testing the hypothesis that an enhanced intervention will be superior to a standard intervention in increasing 
program staff knowledge, self-efficacy, and skill to deliver the adapted ACHIEVE curriculum with high fidelity. 
We will randomly assign 10 community-based psychiatric rehabilitation programs in Maryland to the standard 
or enhanced intervention for ACHIEVE, and we will enroll 2 staff members per program to participate as 
coaches. A peer leader will assist them. The standard intervention will combine real-time onboarding training 
via Zoom, ongoing online training, and online avatar-assisted motivational interviewing practice19,20 for 
coaches, as well as organizational strategy meetings to garner the leadership support for ACHIEVE 
implementation21. The enhanced intervention will include all standard strategies and will add performance 

 
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coaching for ACHIEVE staff coaches. All enrolled coaches will deliver the adapted ACHIEVE curriculum to 
consumers with SMI at each study site. We propose the following Aims: 
2. SPECIFIC AIMS 
Primary Aim: Conduct a pilot randomized clinical trial testing two implementation interventions 
designed to support delivery of ACHIEVE-D at community-based psychiatric rehabilitation programs.  
H1.1. Both the standard and enhanced interventions will increase knowledge of and self-efficacy to deliver 
ACHIEVE-D, and result in high-fidelity delivery of ACHIEVE-D.   
H1.2 Compared to the standard intervention, the enhanced version will lead to greater knowledge, self-
efficacy, and ACHIEVE-D fidelity.  
 
Secondary Aims: 
1. Assess the acceptability, appropriateness, and feasibility of the adapted ACHIEVE curriculum to coaches, 
peer leaders, program directors and other staff. 
2. Assess consumer outcomes of self-reported diet and physical activity, weight, attendance and satisfaction.  
This study will lead to a refined intervention that will contribute to the future development of a certified 
ACHIEVE-D training program for mental health staff and peers, and thus facilitate future widespread 
dissemination of an evidence-based behavioral weight-loss program for individuals with SMI.  
 
3. BACKGROUND & SIGNIFICANCE 
Public health burden of CVD, obesity, and other CVD risk factors in persons with SMI 
CVD is the leading cause of preventable death among persons with SMI4-10, and this population has high 
prevalence of CVD and CVD risk factors22-26. Notably, obesity is extremely common1-3. For example, 60% of 
women with SMI have obesity2,27,28 as compared to 41% of women in the general population29.  
 
Factors that contribute to obesity in individuals with SMI 
Several factors contribute to the high obesity prevalence. First, the vast majority of individuals with SMI take at 
least one long-term psychotropic medication, and these drugs promote weight gain due to increased appetite 
along with metabolic abnormalities such as elevated glucose and lipids30-36. A shared decision-making process 
that provides patients with the expected weight and metabolic effects of these medications has been the 
recommended strategy to clinicians to make an informed decision about choice37. Unfortunately, initial 
selection of or changes to a weight-neutral alternative medication may not be an option for many individuals 
with SMI; therefore, medications are unlikely to be a modifiable risk factor.  
Second, diet and physical activity are typically poor in this population. Studies of individuals with SMI 
demonstrate high calorie and fat intake, as well as low intake of fruit and vegetables38-43. Physical activity 
levels are low in this population44-48. For example, persons with SMI report 50% higher leisure time inactivity 
than the general population45, and an accelerometry study showed only 4% of individuals with SMI met 
recommended moderate to vigorous physical activity in bouts of ≥10 minutes48. These lifestyle habits also 
contribute to obesity and CVD risk among individuals with SMI, and unlike psychotropic medications, represent 
a modifiable CVD risk factor. 
 
Challenge of behavioral weight-loss interventions among persons with SMI 
In general populations, behavioral weight-loss interventions have been demonstrated to improve CVD risk by 
reducing blood pressure and glucose, as well as improving lipid profiles11. Behavioral interventions promoting 
healthy diet, exercise, and weight loss are critically needed, but must be adapted to challenges particularly to 
the SMI population. In particular, memory impairment, limited executive function, and residual psychiatric 
symptoms12,13. 
 
A successful behavioral weight-loss intervention tested in an RCT within the SMI population 
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)15. 
The magnitude of weight loss among individuals with SMI participating in ACHIEVE was similar to the 

 
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magnitude observed in efficacious weight-loss trials in general populations11. The ACHIEVE intervention 
combined group and individual weight-management sessions with group exercise sessions delivered in 
community mental health programs14,15. To address some of the noted challenges in this population12,13, the 
intervention 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 intervention was predominantly delivered by trained study interventionists, though mental health 
program staff delivered some video-assisted group exercise sessions14,15. Given the obesity epidemic in 
persons with SMI, there is an urgent need to “scale-up” or expand ACHIEVE to similar settings and populations 
as those included in the RCT, which we posited could be accomplished by enabling the psychiatric 
rehabilitation program staff to deliver the sessions16. Using the Enhanced Replicating Effective Programs 
Framework for translating evidence-based interventions into community settings17, our scale-up strategy 
considers this model’s three stages: pre-implementation, implementation, and dissemination.   
 
Scaling up ACHIEVE – pre-implementation stage  
We have already completed the pre-implementation stage, during which we adapted the format of the original 
intervention to increase ease of adoption and sustained implementation of ACHIEVE by program staff in these 
community-based programs. (IRB00194122). To realize the full public health potential of ACHIEVE, the 
curriculum needed to be modified for delivery by community mental health staff16. We retained the core 
components, but modified the curriculum schedule (e.g., combined exercise and weight management group 
sessions) and enhanced the delivery format (e.g., video-assisted content) to support efficient, staff-led delivery. 
We pilot tested this adapted curriculum where a trained study interventionist implemented 2 months of 
programming at a community-based psychiatric rehabilitation program18, and we then further refined the 
adapted curriculum based on feedback from program staff and participating individuals with SMI. First, we 
defined the role for a peer leader within ACHIEVE, where a consumer would be recruited to serve as the peer 
leader from the group of participating consumers and the duties would include encouraging other enrolled 
consumers to attend ACHIEVE groups, actively participate in the group exercise sessions to act as a role 
model, as well as assist the ACHIEVE coach with set up and management of curriculum materials. Second, we 
identified the need for an assessment of readiness to make the necessary lifestyle behavior changes among 
consumers to ensure that we enroll individuals who are at an appropriate stage of change to engage in the 
intensive ACHIEVE curriculum. 
In addition, we developed implementation strategies such as organizational strategy meetings with program 
directors and coaches to support the adoption of ACHIEVE in community-based psychiatric rehabilitation 
programs. We also refined procedures and assessment measures for grading coach fidelity to ACHIEVE, as 
well as adapted measures to assess acceptability, appropriateness, and feasibility. 
 
Scaling up ACHIEVE – implementation and dissemination stages 
The ACHIEVE Implementation and Dissemination Pilot Trial represents the next stages of the Enhanced 
Replicating Effective Programs Framework – implementation and dissemination17, which has a particular focus 
on testing innovative interventions to enable psychiatric rehabilitation program staff to deliver ACHIEVE-D. 
The ACHIEVE trial interventionists, who all had bachelor’s or master’s degrees in health-related fields, required 
significant in-person initial and ongoing training on intervention content and motivational interviewing (MI) 14,15. 
MI is an evidence-based patient-centered communication method shown to help people make positive diet and 
exercise changes49-51, and considered a key aspect of ACHIEVE. Traditional MI training includes two days of 
in-person training, followed by repeated post-training feedback and coaching by a master trainer. While the 
community-based psychiatric rehabilitation program staff have valuable experience working with people with 
SMI, they typically have different educational backgrounds and less experience with lifestyle content as well as 
MI communication skills. In real-world community mental health settings, time constraints prevent most 
program staff from participating in the intensive training used among ACHIEVE trial interventionists. Therefore, 
new strategies need to be developed that incorporate advances in training modalities (e.g. online training, 
virtual training environments) to enable psychiatric rehabilitation program staff to deliver ACHIEVE-D. Given 
that training alone is often insufficient to increase wide-spread adoption of new evidence-based interventions52-
55, the ACHIEVE-D curriculum will be supplemented with additional implementation strategies (e.g., 

 
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organizational strategy meetings with program directors and coaches, peer leader identification and training to 
aid coach) to support future implementation and dissemination of ACHIEVE-D in community mental health 
settings. Unless effective interventions like ACHIEVE are translated into real-world settings, obesity and CVD 
disparities among the population with SMI will likely persist or even worsen. 
 
4. DESIGN SUMMARY 
The core design is a randomized, two-arm, parallel, pilot clinical trial where 10 psychiatric rehabilitation 
program sites will be randomized to a 6-month standard or enhanced intervention. This trial will recruit and 
enroll participants at each site – staff, peer leaders, and mental health consumers, (Figure 1). The primary 
outcome variables will be coaches’ knowledge, self-efficacy, and fidelity to the ACHIEVE curriculum. 
 
 
We estimate up to 280 mental health organization staff and peer leaders will participate in data collection 
including program directors, coaches, and other psychiatric rehabilitation program staff. Two coaches and one 
peer leader per study site will be randomized to the standard or enhanced intervention. Up to 120 mental 
health consumers across all sites will be enrolled, and all will receive group weight-management sessions 
delivered by the trained coaches at their site.  
 
The ACHIEVE-D curriculum is designed to fit into and will be part of the regular psychiatric rehabilitation 
programming that is already being conducted.  
 
 
Randomized groups: 
Standard intervention: At those sites assigned to the standard group, two staff and one peer will receive 
training and approximately 8-12 consumers with SMI will participate in the ACHIEVE weight loss program. The 
standard intervention will combine onboarding training, ongoing online training, and online avatar-assisted 
motivational interviewing practice19,20 for all coaches, as well as organizational strategy meetings to garner the 
leadership support for ACHIEVE implementation21.   
Enhanced intervention: At those sites assigned to the enhanced group, the implementation intervention will 
include all standard strategies and will add performance coaching for the coaches. 
 
Trainings and meetings will be remote during the COVID-19 pandemic. 
 
We outline the eligibility criteria sites in Section 5. Then, we describe the eligibility criteria as well as data 
collection and measurements for each study population separately in Sections 6-8. 

 
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5. SITE ELIGIBILITY 
We will recruit approximately 10 
community psychiatric rehabilitation 
programs across Maryland as study 
sites. (Table 1).  
In general, sites will need 1) to be 
an adult psychiatric rehabilitation 
program. 2) Willing to implement the 
ACHIEVE curriculum; 3) Willing to 
support 2 staff members being 
trained as coaches and 
implementing the curriculum; 4) 
Willing to have a peer leader assist. 
 
 
6. STUDY POPULATION: COACHES AND PEER LEADERS 
6.1 Eligibility criteria 
To be eligible to be a coach, the person must be age 18 or older and a staff member at a psychiatric 
rehabilitation program, as well as be willing to do the following: complete all training activities as part of the 
ACHIEVE intervention, deliver all components of the ACHIEVE curriculum to consumers at the program, work 
with a peer leader as part of the ACHIEVE curriculum, and complete data collection procedures as a study 
participant. We will exclude staff who plan on leaving their position or taking a leave of absence from the 
psychiatric rehabilitation program within the next 12 months. 
 
For peer leaders, we will seek individuals 18 years and older who are or are in training to become a Maryland 
Certified Peer Recovery Specialist, or who are mental health consumers with interest who the psychiatric 
rehabilitation program staff and study team believe would be a good fit (e.g., in a vocational program). The 
peer leader must be willing to do the following: complete training activities as part of the ACHIEVE intervention, 
deliver components of the ACHIEVE curriculum to consumers at the program, work with the staff coaches as 
part of the ACHIEVE curriculum, and complete data collection procedures. We will exclude peers who plan on 
leaving their position or taking a leave of absence within the next 12 months. 
 
6.2 Data collection procedures 
Data collection is outlined in Table 2. Data collection for coaches and peer leaders will occur remotely via 
telephone or Zoom and/or online RedCap survey or delivered paper questionnaires. We will collect follow-up 
measures at 3 months and 6 months at completion of ACHIEVE curriculum.  
 
Participant reimbursement for data collection for staff coach participants is estimated at $160 total for 
completing all data collection. Participant reimbursement for data collection for peer leader participants 
includes $75 for completing data collection, up to $320 ($20/hour) for participating in trainings and up to $1500 
($20/hour) per site for participating in delivery of the curriculum.  
 
 
 
Table 1. Criteria for study sites 
• 
Adult psychiatric rehabilitation program with willingness to implement the ACHIEVE 
curriculum at least one time per week for 6 months. 
• 
Willingness to support 2 staff members to be trained and serve as ACHIEVE coaches 
o 
Training: ~16 hours of onboard training; ~2-4 hours per month of additional 
online training; ~1.5 hours per month for performance coaching if site is 
randomized to the enhanced training intervention arm 
o 
Coach duties: Lead at least one (and up to three) 1-hour sessions per week 
of the ACHIEVE curriculum to enrolled consumers 
• 
Willingness to support a peer leader to assist with the curriculum.   
o 
Training: ~16 hours of onboard training; ~2-4 hours per month of additional 
online training  
o 
Peer leader duties: Assist staff coaches  
• 
Organizational leaders and staff to participate in organizational strategy meetings 
with the study team. ~1 meeting every month  
• 
Anticipated ability for study team to recruit consumers to participate in the ACHIEVE 
curriculum 
• 
Ability for study staff to collect data from coaches, consumer participants, and other 
staff members  

 
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Table 2. Data Collection Schedule For Coaches and Peer Leaders 
 
 
Baseline 
Follow-up 
 
During 
6M 
Post 
 
6M Post 
project 
completion 
Primary Outcomes 
 
 
 
 
ACHIEVE curriculum weight management knowledge 
x 
 
x 
 
ACHIEVE curriculum exercise knowledge 
x 
 
x 
 
Self-efficacy to deliver ACHIEVE curriculum 
x 
 
x 
 
ACHIEVE Fidelity Document Assessment Form 
 
x 
 
 
ACHIEVE Fidelity Video Assessment Form 
 
 
x 
 
 
Other Measures 
 
 
 
 
Demographics & prior training 
x 
 
 
 
Attitudes towards individuals with obesity 
x 
 
 
 
Calculated BMI 
x 
 
x 
 
CARDIA/EARLY Q – sedentary behavior 
x 
 
x 
 
Block Dietary Fat Q 
x 
 
x 
 
Block Dietary Fruit/Vegetable Q 
x 
 
x 
 
EARLY Eating Away from Home Q 
x 
 
x 
 
EARLY SSB Consumption Q 
x 
 
x 
 
Perceived Stress Scale 
x 
 
x 
 
Self-Efficacy recall 
 
 
x 
 
Beliefs about Motivational Interviewing 
x 
x 
x 
 
Importance and Confidence of Using MI 
x 
x 
x 
 
Avatar MI Performance Measurements  
Avatar Motivational Interviewing (MI) satisfaction survey 
Perceived Usefulness (motivational interviewing avatar platform) 
x 
x 
x 
x 
x 
 
Fidelity to Motivational Interviewing 
x 
x 
x 
 
Implementation Measures 
 
 
 
 
Acceptability of training 
x 
 
x 
 
Feasibility of training 
x 
 
x 
 
Appropriateness of training 
x 
 
x 
 
Motivation for implementation 
x 
 
x 
 
Implementation Climate  
x 
 
 
 
Qualitative Assessment 
 
 
 
 
Focus Group  
Interviews 
 
 
x 
 
x 
Abbreviations: BMI – body mass index; Q – questionnaire; SSB – sugar-sweetened beverage.  
 
 
 
6.3 Measurements 
Measurements for coaches and peer leaders will be conducted using standardized operating procedures and 
quality control methods.  Specific study forms (RedCap or paper) will be used to collect data.  
 
Primary Outcomes 
Knowledge of the ACHIEVE curriculum. We will assess knowledge about key elements of the ACHIEVE 
curriculum using two measures: A 22-item ACHIEVE Curriculum Weight Management Knowledge measure 
and a 16-item ACHIEVE Curriculum Exercise Knowledge measure The study team created these questions 

 
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using best practices recommended by the National Board of Medical Examiners for item writing56. These 
measures will be assessed at baseline and 6 months. 
 
Self-efficacy to deliver the ACHIEVE curriculum. We will assess self-efficacy to deliver key elements of the 
ACHIEVE curriculum, where participants rate their confidence to deliver each element on a 10-point scale. The 
study team used principles from other related self-efficacy measures in creating our measure57,58. This 
measure will be assessed at baseline and 6 months. Given that this type of self-report measure may be subject 
to response shift bias59,60, we will also have coaches reflect upon their baseline ability to carry out these 
elements at the 6-month point, which will enable us to determine whether response shift bias may be present.  
 
Fidelity to the ACHIEVE curriculum (ACHIEVE fidelity video assessment form and ACHIEVE fidelity 
documentation assessment form). To determine fidelity to the curriculum, we will use two data sources. First, 
coaches will video-record two ACHIEVE group sessions each month at each site, one per coach. Two study 
team members will view each recording and use a rating tool to assess fidelity to key elements of the 
ACHIEVE curriculum. We will calculate inter-rater reliability between coders. Second, a study team member 
will examine documentation practices of the coaches on the same day that video tapes are obtained. The 
study team has identified elements from both data sources that will be summed to create a composite score. 
Numerical values from all items will be used. For Y/N items, ‘Yes’ will equal a numerical score of 2 and ‘No’ a 
numerical score of 1. 
 
Other Measures 
Demographics and prior training. We will collect demographic information such as age, sex, race and ethnicity. 
We will assess educational level and employment status. We will determine prior training in nutrition, exercise 
and weight loss at baseline, as well as their proficiency in using computers and online education. We will 
assess this at baseline, as prior training in these areas may influence our primary outcomes. 
 
Attitudes towards individuals with obesity. We will determine attitudes towards individuals with obesity using 
elements from a previously validated measure61.  We will assess this at baseline, as attitudes towards 
individuals with obesity may influence our primary outcomes. 
 
 
Physical activity. We will administer the CARDIA-EARLY Sedentary Behavior questionnaire, which is the 
measure recommended by the NIH for this outcome within weight loss trials62,63. 
 
Dietary change. We will administer Block Fat, Fruit, Vegetable and Fiber Screener Questionnaires as the food 
frequency measures64,65.  These screeners provide a reasonably valid assessment of intake of these foods and 
have the advantage of being very brief. We will also administer the EARLY Eating Away from Home and 
Sugar-Sweetened Beverage questionnaires, which are the measures recommended by the NIH for these 
outcomes within weight loss trials62,63.  
 
Stress. We will administer the perceived stress scale66 , which is the measure recommended by the NIH for 
this outcome within weight loss trials62,63. 
 
Self-efficacy recall.  This instrument asks participants to recall their self-efficacy before training. 
 
Beliefs about Motivational Interviewing. We will administer a 7-question survey assessing the extent to which 
each person agrees with statements about motivational interviewing. 
 
Importance and Confidence of Using Motivational Interviewing. We will administer a 6-question survey 
assessing the importance and confidence each person has with motivational interviewing. 
 
Avatar Motivational Interviewing Performance Measurements: Participants will use the avatar platform and 
conduct 15-minute practice conversations where they practice use of motivational interviewing techniques in 

 
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simulated conversations about weight loss with consumer avatars on the Kognito platform. An online 
dashboard will give them an individualized report on their performance each time they practice.  
 
Avatar Motivational Interviewing (MI) satisfaction: Participants will respond to their use and satisfaction of the 
Motivational Interviewing (MI) training and practice simulations provided during the course of the six month 
project. 
 
Perceived Usefulness (motivational interviewing avatar platform): Participants will respond to their perceived 
usefulness of the motivational interview avatar platform during the course of the six-month project. 
 
Fidelity to Motivational Interviewing: Standardized Actor Interviews will be conducted to assess fidelity to 
motivational interviewing for coaches. Coaches will conduct 30-minute audio-recorded phone interviews with 
standardized patient actors. These standardized patient actors are trained actors playing consumers with SMI 
who are overweight or obese.  
 
Implementation Measures 
Acceptability, Feasibility and Appropriateness. We will determine perceptions of acceptability, feasibility and 
appropriateness of the ACHIEVE curriculum and the training that they received to deliver this curriculum. 
These measures were adapted from previously validated measures67. 
 
Motivation and Implementation Climate. We will assess these constructs by adapting previously validated 
instruments68,69 . 
 
Qualitative Assessment 
Focus Groups. Focus groups will be conducted with select staff, staff coaches, and peer leaders at the end of 
the study. The focus group is designed to elicit measures in the following domains: perceptions of the 
acceptability, appropriateness, and feasibility of the ACHIEVE curriculum and the implementation of the 
intervention; barriers to ACHIEVE implementation; strategies to overcome barriers; and suggestions for further 
refinement. The focus groups will inquire about perceptions of the acceptability, appropriateness, and feasibility 
of the ACHIEVE curriculum and the implementation of the intervention; barriers to ACHIEVE implementation; 
strategies to overcome barriers; and suggestions for further refinement. They will be conducted by Zoom 
video-conference and will be approximately 90 minutes in length. Participants will receive $25 for participation. 
 
Interviews. Interviews will be conducted at least six months post project completion with staff coaches and/or 
administration. The interviews are designed to understand if/how the organization has continued implementing 
the ACHIEVE curriculum. We will assess which aspects of the curriculum were liked and helpful, which aspects 
were changed and why those changes were made, and what, if any, training was provided to staff to continue 
delivery of the ACHIEVE program. We also aim to understand if changes were made at the organizational level 
to support continued delivery of the ACHIEVE program. Interviews will be conducted by Zoom video-
conference and will be approximately 30 minutes in length. With permission, they will be recorded and 
transcribed. Participants will receive $25 for completing the interview. 
 
7. STUDY POPULATION: CONSUMER PARTICIPANTS 
7.1 Eligibility criteria 
To be eligible to be an ACHIEVE participant, the person must be a consumer with SMI enrolled in a psychiatric 
rehabilitation program, age 18 or older, have a body mass index (BMI) ≥ 25 kg/m2, and willing to make 
changes in diet and exercise to lose weight, as well as: willing to participate in all activities in the ACHIEVE 
curriculum at least 1 day per week, competent to give informed consent, and complete all data collection 
procedures. We aim to be generalizable while including individuals safe to participate in a weight loss program 
that includes moderate intensity exercise. Table 3 provides eligibility criteria for consumers. 
Table 3. Eligibility Criteria for Consumers as ACHIEVE Participants 
Inclusion criteria 

 
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• 
Age 18 and older 
• 
Enrolled in a psychiatric rehabilitation program  
• 
BMI ≥ 25 kg/m2 
• 
Willing to make changes in diet and exercise to lose weight 
• 
Willing to attend the ACHIEVE group sessions virtually or in-person at least once per week  
• 
Ability to use a computer or tablet  
• 
Competent and willing to give informed oral consent 
• 
Completion of baseline data collection 
Exclusion criteria 
• 
Any underlying medical conditions that could seriously reduce life expectancy, ability to participate in the study, or for which 
dietary change/physical activity/weight loss may be contraindicated e.g., 
o 
Lung disease requiring supplemental oxygen 
o 
Liver failure 
o 
History of anorexia nervosa or bulimia 
o 
Stage V kidney disease on dialysis 
o 
Cardiovascular event in the last 6 months including unstable angina, myocardial infarction, congestive heart failure, 
transient ischemic attack, or stroke 
• 
Insulin dependent diabetes 
• 
Inability to walk unassisted (e.g., uses a cane, walker, etc) 
• 
Pregnant, breastfeeding, or planning a pregnancy during study period 
• 
Prior or planned bariatric surgery 
• 
Use of a prescription anti-obesity medication or over-the-counter orlistat within the past 3 months 
• 
Self-reported weight loss of >20 lbs in the last 3 months 
• 
Active substance use disorder, alcohol use disorder, or problem drinking (more than 14 drinks per week for women, more than 
21 drinks per week for men) 
• 
Planning to leave mental health program or move out of geographic area within 12 months 
• 
Weight greater than 440 pounds (so as not to exceed capacity of study scale) 
• 
Investigator judgment (e.g., for concerns over safety, adherence or follow-up) 
 
7.2 Data collection procedures 
Our study team has worked with several hundred persons with serious mental illness as study participants in 
intervention trials for more than 15 years. 
 
For this study, when possible, data collection will occur at psychiatric rehabilitation centers, with all appropriate 
precautions in place to remain safe during the pandemic. If the participant cannot come to the center (e.g., kf 
the center is not open) measures will be collected over the phone/zoom and with participants self-measuring 
weight on a scale the team provides for them.  
 
Participant reimbursement for data collection for all participants is estimated at $60 total for completing all data 
collection points. 
 
Participant eligibility is determined by a combination of information provided by psychiatric rehabilitation 
program staff prior to consumer consent (with HIPAA waiver) and from several baseline measures after 
consent.  
 
In response to the pandemic, several safety measures will be in place when meeting in person:  
• 
Community mental health programs are regulated by the state of Maryland and currently have 
COVID safety protocols in place.  
• 
Participants will be required to wear a mask at all times. One will be provided by the study team if 
needed.  
• 
Research staff will wear PPE during in-person data collection. 
• 
All equipment will be cleaned and disinfected before and after data collection using appropriate 
cleaning methods. 
• 
Prior to an in-person visit, we will screen consumers by phone for virus/disease symptoms and 
exposure with the Ambulatory Screening Algorithm for COVID-19. Screening will occur the day prior 
to the visit. If symptoms or exposure are reported, we will not conduct the visit, we will alert mental 

 
13 
 
health program staff and also advise consumer to contact their primary care provider. In addition, 
mental health programs conduct their own screening prior to in-person attendance.  
• 
During the in-person visit, study staff will instruct the consumer how to use a tablet to complete data 
collection and how to use Zoom. The study tablet will already be set up for the consumer.   
• 
We plan to then discuss and obtain consent and survey data via videochat/Zoom with the 
participant in the next room. Study staff will review surveys with the consumer via Zoom. If the 
consumer is not able to follow along, study staff may sit in the same room, more than 6 feet apart, 
and read questions to the participant. 
• 
We plan to collect weight, height, and blood pressure in-person. Research staff will take appropriate 
precautions when coming within 6 feet of participants and will minimize in-person time. We estimate 
that research staff will need to come within 6 feet of participants for a total of 13 minutes: Taking 
weight and documenting: 3 minutes; Taking height and documenting: 3 minutes; Taking 
measurements of the arm and wrapping of blood pressure cuff: 4 minutes; Documenting blood 
pressure and unwrapping cuff: 3 minutes. 
 
 
We will assess eligibility in the following ways.  
1. We will measure weight and height.   
2. We will assess pre-participation health screening in preparation for a moderate intensity exercise program 
that includes the modified 2018 Physical Activity Readiness Questionnaire (2018 PAR-Q), a checklist of 
medical conditions for health screening, and blood pressure measurement.  
• 
The ACHIEVE curriculum emphasizes the achievement of moderate, not vigorous, intensity 
physical activity. The safety of moderate intensity physical activity in properly screened subjects is 
well established. 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 
program70. 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.  
• 
If potential participants endorse high risk symptoms on 2018 PAR-Q (e.g., chest pain or dizziness) 
or have a medical condition where physical activity and/or weight loss may be contraindication, we 
will communicate with their primary care provider to assess appropriateness for the program.  
• 
For patients with hypertension and non-insulin-dependent diabetes mellitus, we will send a letter to 
their primary care physician alerting these physicians to their patients’ interest in participating in a 
weight loss program and their need for medical supervision. This letter will request that the 
physician agree to monitor and manage the patient’s hypertension and/or diabetes mellitus during 
participation in the program.  
• 
For other participants, we will send a letter to primary care physicians alerting these physicians to 
their patients’ participation in a weight loss program.  Due to state regulations, almost all consumers 
will have primary care physicians; we will work with rehabilitation program staff to facilitate referral 
to primary care for those who do not.  
3. We will review consumer medical records and medications for any exclusion criteria.   
4. We will assess readiness to make changes needed to lose weight. 
5. We will discuss with consumers and staff plans to remain at the rehabilitation center and be available to 
participate either in-person or remotely. 
 
7.3 Measurements 
Measurements will be conducted using standardized operating procedures and quality control methods.  
Specific study forms either in RedCap or paper will be used to collect data.  
  
Table 5. Data Collection Schedule for Consumers 
 
 
 
Follow-up 

 
14 
 
Screening/
Baseline 
During 
6M 
Post 
General Assessments 
 
 
 
Evaluation to Give Consent 
x 
 
 
Demographics  
x 
 
 
Exercise pre-participation screening (modified 2018 PAR-Q) 
x 
 
 
Medical history 
x 
 
 
Medications 
x 
 
x 
Readiness rulers 
x 
 
 
Physical Measurements 
 
 
 
BMI 
Blood pressure 
X 
x 
 
x 
Physical Activity 
 
 
 
CARDIA/EARLY Q – sedentary behavior 
x 
 
x 
Diet 
 
 
 
Block Dietary Fat Q 
x 
 
x 
Block Dietary Fruit/Vegetable Q 
x 
 
x 
EARLY Eating Away from Home Q 
x 
 
x 
EARLY SSB Consumption Q 
x 
 
x 
NHIS Screener 
x 
 
x 
Satisfaction 
 
 
 
Consumer Satisfaction & Helpfulness Q 
 
 
x 
Other Measures 
 
 
 
Palatable Eating Motives Scale (PEMS) – Coping Subscale 
x 
 
x 
Reward-based Eating Drive (RED) Scale 
x 
 
x 
Important Others Q 
x 
 
x 
Medical Events  
 
 
x 
Perceived Stress Scale (PSS) 
x 
 
x 
Ambulatory Screening for COVID-19 
x 
 
x 
 
 
General Assessments  
Demographics. We will collect demographic information such as age, sex, race, and ethnicity. We will also 
assess how often they attend the program.  
 
We will use several measures and data sources to assist in determining eligibility for the study. Exercise pre-
participation screening (modified 2018 PAR-Q): This modified physical activity readiness questionnaire will be 
used to assess if consumer is able to participate in exercise classes. Medical History: We will collect medical 
history information from each consumer to assess ability to participate in the ACHIEVE program and the staff. 
Medications: We will list all of the consumer’s current medications. We will use the Readiness Rulers survey to 
assess participant’s readiness to lose weight and willingness to participate in the ACHIEVE program.  
 
Anthropometrics – blood pressure, weight, height and BMI. We will assess blood pressure, height and weight 
at baseline. Weight will be measured to the nearest 0.1 lb. by a high-quality digital scale with participants 
wearing light indoor clothes without shoes. Weight will be measures in lbs. for ease of interpretation by 
participants and converted to kg for calculation of BMI, calculated as the Quetelet index (kg/m2). Height will be 
measured to the nearest 0.1 cm using a wall-mounted stadiometer. Blood pressure will be determined by the 
OMRON 907 XL, a validated device that records BP using an oscillometric technique71. One blood pressure 
with 3 measurements (each separated by 30 seconds) will be obtained on the right arm of participants after 

 
15 
 
they rest quietly in the seated position for at least 15 minutes72. If measures cannot be in person, participants 
will self-measure weight on a scale the team provides for them.  
 
Physical activity. We will administer the CARDIA-EARLY Sedentary Behavior questionnaire, which is the 
measure recommended by the NIH for this outcome within weight loss trials62,63. 
 
Dietary change. We will administer Block Fat, Fruit, Vegetable and Fiber Screener Questionnaires as the food 
frequency measures64,65.  These screeners provide a reasonably valid assessment of intake of these foods and 
have the advantage of being very brief. We will also administer the EARLY Eating Away from Home and 
Sugar-Sweetened Beverage questionnaires, which are the measures recommended by the NIH for these 
outcomes within weight loss trials62,63. We will also administer the NHIS Dietary Screener Questionnaire with 
26 questions.  
 
 
Satisfaction. We have adapted a prior measure used to assess helpfulness of various elements of another 
behavioral weight loss intervention73, as well as adapted a measure previously validated among consumers 
with SMI to assess satisfaction with care74. 
 
Eating habits. We will administer two measures -- Palatable Eating Motives Scale (PEMS) – Coping Subscale 
and Reward-based Eating Drive (RED) Scale, which assess emotional factors that influence eating habits. We 
will also administer the Important Others Questionnaire that assess social factors that influence eating habits. 
All of these measures recommended by the NIH for these outcomes within weight loss trials62,63. 
 
Stress. We will administer the perceived stress scale66, which is the measure recommended by the NIH for this 
outcome within weight loss trials62,63. 
 
Medical events.  We will also capture any medical events that occur during the 6-month intervention. 
 
Important others. We will capture information about support systems and people in the consumer’s life that can 
assist in healthy weight management behaviors.  
 
Intervention process measures. During the weight management curriculum, attendance, participation and 
weight measurements will be collected.  
 
8. STUDY POPULATION: OTHER STAFF 
8.1 Eligibility criteria 
To be eligible as other staff, the person must be a staff member at a psychiatric rehabilitation program and age 
18 or older, as well as willing to do the following: review waiver of documentation of informed consent with 
study staff and complete data collection procedures.  
 
8.2 Data collection procedures 
Data collection timeline is outlined in Table 6. Data collection will occur with study forms either in RedCap or 
paper. Focus groups will be conducted by Zoom. Participant reimbursement for data collection for other staff 
participants is estimated at $45 total for all data collection points, divided over each time point.  
 
 
Table 6. Data Collection Schedule for Other Staff 
 
Baseline 
Follow-up 
During 
6M 
Post 

 
16 
 
 
x 
 
 
Other Measures 
 
 
 
Demographics & prior training 
x 
 
 
Implementation Measures 
 
 
 
Motivation for implementation 
x 
 
x 
Implementation Climate  
x 
 
 
Qualitative Assessment 
 
 
 
Focus Group  
 
 
x 
 
 
Demographics and prior training. We will collect demographic information such as age, sex, race, and ethnicity. 
We will assess educational level and employment status. We will determine prior training in nutrition, exercise 
and weight loss at baseline, as well as their proficiency in using computers and online education. 
 
Motivation and Climate for Implementation. We will assess these constructs by adapting previously validated 
instruments68,69. 
 
Qualitative Assessment 
Focus Groups. Focus groups will be conducted with select staff, staff coaches, and peer leaders at the end of 
the study. The focus group is designed to elicit measures in the following domains: perceptions of the 
acceptability, appropriateness, and feasibility of the ACHIEVE curriculum and the implementation of the 
intervention; barriers to ACHIEVE implementation; strategies to overcome barriers; and suggestions for further 
refinement. Focus group participants will be represent all study sites. The focus groups will inquire about 
perceptions of the acceptability, appropriateness, and feasibility of the ACHIEVE curriculum and the 
implementation of the intervention; barriers to ACHIEVE implementation; strategies to overcome barriers; and 
suggestions for further refinement.  They will be conducted remotely by Zoom video-conference and will be 
approximately 90 minutes in length. Participants will receive $25 for completion of focus group.  
 
 
9. QUALITY ASSURANCE AND QUALITY CONTROL 
Quality Assurance pertains to activities that promote collection of high-quality data, and Quality Control refers 
to activities that detect emerging data issues with sufficient time to implement appropriate corrective actions.  
Our approach to Quality Assurance includes: 1) preparing a manual of operations; 2) implementing a master 
trainer model to train and certify other staff; 3) train and certify all data collectors on in-person and remote 
procedures; 4) recertify data collectors at least annually; 5) routinely calibrate equipment; 6) maintain logs of 
certified staff and calibrated equipment.  Our approach to Quality Control includes: 1) monitoring counts of 
completed data collection items; 2) monitoring distribution of trial outcomes, overall, by data collector and site; 
3) record lag time in data entry; 4) issue queries on missing data, out of range values or illogical data relations; 
4) review types and distribution of data entry errors; and 5) prepare reports for staff, investigators, and an 
independent study monitor on Quality Control.  
 
10. RANDOMIZATION AND BLINDING 
Following baseline data collection, sites will be randomized to the standard or enhanced arms. Randomized 
blocks of 2 in random order will be used to create the randomization sequence. The random sequence and 
allocation groupings will be stored in RedCap, only the data analyst will distinguish the treatment assignment to 
sites. Due to the nature of the intervention, both participants and interventionists will be aware of the 
assignment. Data collectors measure study outcomes. Investigators, staff and participants are masked to 
outcome data, with the exception of trial statistician, study coordinator, data analyst and independent study 
monitor.  
 
 
11. INTERVENTION GROUPS 

 
17 
 
An overarching principle of the adapted ACHIEVE-D curriculum is that it is designed to fit into and will be part 
of the regular programming that psychiatric rehabilitation programs are already providing for their clients with 
mental illness. The psychiatric rehabilitation program staff trained as ACHIEVE-D coaches will have the 
support of their leadership for ACHIEVE-D program delivery. Based on discussions with and requests from the 
study sites, each site will decide how they will deliver the ACHIEVE-D curriculum during COVID, taking into 
consideration how they are delivering their other programming, their priorities, and resources. If psychiatric 
rehabilitation programs are delivering in-person programming, then they will likely plan to deliver ACHIEVE-D 
in-person at least once per week. For persons with serious mental illness, in-person programming is preferred 
due to psychiatric symptoms, cognitive impairment, and potential challenges using smartphones and 
computers. To support sites that prefer to offer remote groups, we will be providing clients with Grandpads 
(tablets). Our study team will train consumers to use the devices during baseline data collection and Coaches 
will troubleshoot technology issues that arise during groups. We expect most sites will use a hybrid method of 
delivery during COVID with both in-person and remote sessions. Sites follow Maryland Medicaid and other 
regulatory guidelines for safety and operating procedures. Sites will have the flexibility to change their delivery 
method during the study. (We have discussed these plans with Megan Singleton). Peer leaders will assist staff 
coaches as appropriate including considering COVID restrictions at each site.  
 
In-person group exercise classes may be held during COVID-19 depending on each site’s COVID safety 
protocol. Exercise classes may be delivered via Zoom video-conferencing as part of the ACHIEVE group or 
offered as a supplemental session led by a trained peer leader with support from the study team.  
 
11.1 
ACHIEVE Curriculum 
All sites will use the ACHIEVE curriculum, a six-month behavioral weight loss program delivered by trained 
coaches with the assistance of peer leaders to enrolled mental health consumers at the 10 PRPs. ACHIEVE 
classes will be offered at least once per week (up to 3 days per week) for about 1 hour. Classes may be 
delivered in person or virtual depending on COVID 
restrictions in place at each PRP. Obesity is a 
chronic condition which benefits from ongoing 
intervention, and the curriculum is designed to be 
integrated into regular PRP programming. The 
curriculum includes six monthly core modules and 
seasonal modules that can be incorporated into the 
curriculum depending on the time of year the 
program is delivered (Exhibit 1). Within each monthly 
module, the topic varies by week. When sites are 
delivering more than one weight management class 
each week, the content will be repeated ; repetition of 
messages is a key tenet of intervention tailoring for 
persons with SMI. Coaches will use motivational 
interviewing communication techniques in all 
interactions with consumers. This curriculum was 
adapted from the behavioral intervention previously 
tested by Daumit and colleagues15. We have also 
previously tested two months of this adapted 
curriculum at one PRP in a proof-of-concept study, 
which found that the format was feasible and 
acceptable to consumers and staff. 
 
In-person group exercise classes may be offered 
during COVID-19 with appropriate safety protocols (e.g., social distancing, proper room ventilation). Exercise 
classes may also be delivered via Zoom video-conferencing as part of remote groups. For remote sessions, 
exercise class will occur during the first 20 minutes of the session via Zoom. The coach may play an exercise 
video over Zoom.  If the site is using a hybrid model of delivery with some weight management sessions 
Exhibit 1.  6-Month ACHIEVE Curriculum Overview 
Type and Frequency of Contact  
Multipurpose group weight management class: 1-3 times per 
week for 50-min class (30 min weight management and 20 min 
exercise (see above)) led by trained ACHIEVE staff and peer 
coaches 
Weigh-ins: occur on the day of each class (10 min) (or virtually) 
Curriculum Delivery Modality 
Weight management: Facilitated session with short videos  
Exercise: Video-assisted group exercise 
Goals and Recommendations 
Weight loss goal 5% in 6 months 
Behavioral recommendations: 6 Core Modules Weight loss 
success 
• 
No sugar drinks 
• 
No junk food 
• 
Eat smart portions 
• 
Eat more vegetables 
• 
Putting it all together 
Seasonal modules available to tailor experience 
• 
A New Start in the New Year 
• 
Heart Healthy Valentine’s Day 
• 
Maintain Don’t Gain during Celebrations 
• 
Spring into Walking 
• 
Halloween Fun without the Sugar 
• 
Maintain Don’t Gain during the Holidays 

 
18 
 
occurring in-person, the coach may offer additional physical activity classes to be delivered via Zoom or 
recommend online exercise videos for participant. The coach will recommend daily physical activity for at least 
20 minutes, whether in an ACHIEVE session or not, specifically emphasizing low impact moderate intensity 
aerobic exercises such as going on walks.  
 
Video-based virtual exercise classes may also be offered as a separate group that is facilitated by the peer 
leader and study team staff. The peer leader will be trained to co-lead these groups using an ACHIEVE-
approved low-impact moderate intensity aerobic video (e.g., Walk Away the Pounds). Groups will last 20 
minutes and include a warm-up and cool-down. To ensure participant safety, the study team member will 
confirm each participants’ contact information at the beginning of each class (e.g., name, address from which 
they are joining the exercise class, phone number and emergency contact). The peer leader will facilitate the 
class, and the study team member will monitor participants via video. These groups will be scheduled at times 
that do not conflict with the Coach-led ACHIEVE groups. When sites are delivering in-person groups and are 
not able to incorporate group exercise into the curriculum (due to COVID safety protocols), these virtual 
exercise classes provide an option for clients to engage in exercise from the safety and convenience of their 
home while also benefiting from the support of their peers.  
  
 
11.2 
Standard Intervention Group 
The standard intervention components are described in Exhibit 2. Staff Coaches and Peer Leaders will 
participate in all trainings.   
12. 
 
Exhibit 2. Overview of Standard Intervention Components  
 
Component 
Elements 
Standard 
On-Board 
Training 
During training sessions, a mix of didactic content and role play are used. Materials needed to implement 
all components the ACHIEVE weight-loss curriculum is covered. More detail on how to discuss each 
weight-loss subject is introduced in a stepwise fashion. Training on motivational interviewing (MI) 
techniques is also provided. Master trainers who have expertise in health coaching and MI training conduct 
the initial on-board training. 
Online 
Training 
Modules 
Monthly online didactic training modules (15-20 min) are an efficient method for coaches to observe and 
learn how to deliver the ACHIEVE weight-loss topics. Each training module includes both relevant didactic 
content and examples of experienced ACHIEVE staff providing real-world examples of delivering the 
content in groups. Coaches view the online modules each month before teaching that specific component 
of the program. 
Online Avatar 
MI Practice 
Module 
At the end of the on-board training, coaches are given access to an online avatar MI practice module, 
which includes a 15-minute didactic component and 15-minute virtual practice conversations with 
consumers with SMI. These simulated conversations allow coaches to practice (a) providing feedback 
about weight-loss progress and (b) increasing participant engagement in exercise classes. The avatar 
module includes built-in MI performance feedback. Coaches are encouraged to use the module weekly for 
the first three months and as needed (e.g., monthly), repeating practice until they receive a “good” score.  
Our training approach provides interactive opportunities for coaches to practice the skills needed to implement 
the ACHIEVE curriculum, a strategy more effective than didactic education.  
At minimum, each Coach will be video-recorded delivering an ACHIEVE group during months 1, 3 and 6; each 
coach may be recorded monthly. These recordings will be for research purposes only and will not be shared 
with the site supervisors. Recordings will be shared with master trainers on the study team who are 
responsible for assessing fidelity to the ACHIEVE curriculum (master trainer grading will not be used in 
outcome scoring). 
 
To enhance the uptake of ACHIEVE we will meet with leadership for organizational strategy meetings to 
increase leaders’ engagement with evidence-based practice implementation. These meeting will be held 
approximately monthly and will include the PRP director and ACHIEVE coaches. These meetings support 
development, adoption, and sustainment of organizational strategies needed for program implementation (e.g., 
changes to class schedules to maximize attendance) as well as implement strategies that demonstrate 
leadership buy-in to ACHIEVE. 

 
19 
 
 
 
11.3 
Enhanced Intervention Group 
The enhanced intervention includes all components of the standard intervention along with the addition of 
performance coaching. Performance coaching may be particularly beneficial when, as in the present case, the 
evidence-based practice is new to most implementers.  Each month a master trainer on the study team will 
meet with the Coach to provide tailored feedback and performance coaching session. The feedback will be 
used to 1) promote curriculum fidelity; 2) facilitate motivational interviewing skill development; and 3) help 
coaches plan for improved ACHIEVE curriculum delivery. 
 
 
12. DATA MANAGEMENT and SECURITY 
Quantitative Data. Each participant will be assigned a unique study ID number for data collection, instead of 
name or other identifying information. The link between identifying information and the study ID will be kept in a 
separate database with password access available only to the data analyst, statistician and principal 
investigators. Study team members are trained to protect integrity and confidentiality of the data. Data will be 
published only in aggregate, with no identifying characteristics of individuals published or presented. We will 
store data in a Johns Hopkins REDCap database. REDCap data is housed on secure servers at the Johns 
Hopkins Biostatistics Center under firewall protection. Database access is password protected and restricted to 
authorized personnel only and REDCap provides audit trails for tracking data manipulation and user activity. 
Any paper records will be kept in locked file cabinets. Kognito, a health simulation company, developed the 
avatar simulations for this project and hosts the avatar training platform and dashboard. Avatar performance 
measurement data for motivational interviewing practice conversations is accessible only by the individual 
study participant (provider) and the study team, not shared outside Kognito. Kognito stores data securely 
behind two firewalls.  
 
Built-in range and logic checks will prompt data checks and confirmation in real-time during data collection. 
The analyst will routinely conduct thorough checking and cleaning, examining distributions and data patterns 
and evaluation to detect inconsistencies. Outliers (e.g., extreme weight changes) will be identified using 
Rosner’s extreme Studentized deviate (ESD). Every effort will be made to determine correctness of outliers in 
a timely manner. Confirmed outliers will be flagged and set aside in the principal secondary analyses. Those 
removed will be treated as all other missing data; sensitivity analyses will be conducted to assess influence of 
outliers on results. The analyst will create detailed variable documentation and conduct analysis per protocol 
under direction of Dr. Wang, statistician.   
 
 
Qualitative Data. Focus groups will be audio or video-recorded and recordings will be transcribed using 
Production Transcripts, Inc or another approved Johns Hopkins vendor. Names will be removed from 
transcripts. Recordings will be stored in a Johns Hopkins secure network drive and will be destroyed when 
analyses are complete. Standardized actor interview recordings will be reviewed by experts in motivational 
interviewing for fidelity to motivational interviewing practices and stored in a Johns Hopkins secure network 
drive or OneDrive. 
 
13. DATA ANALYSIS 
We will assess the effects of the implementation intervention on providers’ knowledge self-efficacy, and fidelity 
to the ACHIEVE curriculum, as well as consumer outcomes using generalized linear mixed-effects models 
under the intent-to-treat approach. Mean models will include a binary intervention group indicator, time 
indicators, intervention by time interaction terms, and fixed effects for the 10 study sites. The time indicator 
coefficients estimate time-specific mean outcome changes in the “standard” group and interaction coefficients 
estimate the between-arm differences of time-specific outcome changes from baseline. The linear combination 
of these time-specific coefficients captures the time-specific mean outcome changes in the “enhanced” group.  
The model will use an unstructured variance covariance matrix for the repeated outcome measurements over 
time within individuals. To assess whether knowledge and self-efficacy mediate implementation intervention 

 
20 
 
effects, we will estimate the magnitude of attenuation on intervention effects in the consumer outcome models 
with vs. without these measures. We will also examine potential moderators, e.g. study sites’ implementation 
intervention fidelity and/or implementation climate, by adding appropriate interaction terms to the models. 
We will analyze survey data on our implementation measures prior to conducting focus groups in order to 
explore survey findings in depth (e.g., if providers’ rate performance coaching as having mediocre 
acceptability, we will explore reasons why in the focus groups). We will use descriptive statistics to analyze 
survey measures of perceptions of acceptability, feasibility and appropriateness of implementation intervention 
and ACHIEVE-D. Point estimates and corresponding 95% confidence intervals will be obtained.  
 
 
14. HUMAN SUBJECTS 
All study staff will complete the web-based Collaborative Institutional Training Initiative (CITI) for Basic Human 
Subjects Research, Conflict of Interest Training and training in the Health Insurance Portability and 
Accountability Act (HIPAA). All study participants have a waiver of documentation of written consent using 
procedures reviewed and approved by Johns Hopkins Institutional Review Boards. The consent scripts cover 
all procedures done as part of data collection and the intervention.  
 
Sources of materials  
Data collectors will conduct assessments in-person and/or remotely. Eligibility will be determined through 
baseline data collection procedures for each study population. To determine eligibility for the study for 
consumer participants, we will also obtain permission from potential subjects to talk with mental health program 
staff and clinicians and contact their primary care physician and psychiatrist concerning any medical or 
psychiatric reasons for study exclusion. We will communicate with these physicians to ensure there are no 
contraindications to participating in the intervention. We will document assessments in each subject’s study 
chart.  
 
Safety Monitoring for Consumer Participants 
Consumer participant safety will be closely monitored. Protection of these research participants begins with the 
eligibility criteria, which are designed to exclude individuals with a serious medical condition or psychiatric 
instability that would make it unsafe for them to take part in a weight-loss program. During the study, regular 
mental health and primary care will be provided by the participant’s usual mental health and primary care 
providers, not by the study. Participants will be made aware of this delineation of responsibility.  
 
We will carefully monitor the safety of enrolled participants. If a participant develops a medical or psychiatric 
issue, the safety of continuing or resuming participation in the weight-loss program will be ascertained by the 
study clinician in collaboration with the participant’s regular providers. Surveillance for serious adverse events 
and other relevant clinical events will occur at the six-month mark. 
 
A study clinician, Dr. Murphy (independent study monitor), with appropriate expertise will be responsible for 
reviewing medical eligibility criteria and clinical measures, and will be the primary contact for staff, participants 
and physicians for medical issues. This clinician will review and report any serious adverse events and will 
have appropriate coverage during absences to provide 24/7 medical safety coverage for the study. 
 
15. POTENTIAL RISKS 
Potential risks differ by study population. 
 
All research studies have some degree of risk or discomfort. Time burden in responding to surveys and 
discomfort during interviews using sensitive questions are common risks and discomforts of minimal risk 
studies that use an oral consent process. 
 
Staff participants may become tired or bored during surveys, interviews or focus groups. 
 

 
21 
 
There are risks related to physical activity and nutrient intake, including hypoglycemia and symptomatic 
hypotension related to diet and exercise interventions. Protections against these risks are described below. We 
have also set alert values for baseline blood pressure data collection, we have procedures in place for 
surveillance and reporting, and our exclusion criteria is meant to exclude people for safety reasons. 
 
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 will focus on mild to moderate intensity aerobic 
exercise using progression of intensity and duration appropriate for sedentary individuals. 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. 
 
Surveillance for serious adverse events and other relevant clinical events that may be associated with study 
participation will occur at the six month mark. This is done using a standardized questionnaire. In addition to 
the end of study report participants may report events in other settings (e.g., intervention contacts). A study 
clinician will review the completed forms, will classify the event according to several dimensions 
(expectedness, relatedness and type) and will take appropriate action. Safety-related events will be reported in 
a timely fashion as required by the IRB and NIMH.   
 
Expected events 
Over the duration of the six month project a number of medical events may be expected to occur in overweight 
or obese adults, including routine surgeries and procedures, the development of cancer and other chronic 
conditions, increased symptoms from a chronic condition, musculoskeletal problems and motor vehicle 
accidents. 
 
Importance of knowledge to be gained  
Persons with SMI have high burdens of each major cardiovascular risk behavior, yet persons with SMI have 
been systematically excluded from interventions to decrease cardiovascular risk. If successful, this proposed 
program and curriculum could be disseminated widely. The minimal health risks to participants are offset by 
the potential benefits to participants and to the greater population with chronic mental illness. 
 
16. ADEQUACY OF PROTECTION AGAINST RISKS 
 
 
Organization staff will be appropriately recruited and informed of the study by study team with waiver of 
documentation of informed consent. They study team will inform them that they do not have to answer any 
questions they do not want to, and that their employment or evaluations will not be affected by their responses. 
This is a minimal risk study. 
 
There will not be a Data Safety Monitoring Board (DSMB) for this project. Participant safety will be closely 
monitored. We will have an independent study monitor who is experienced in clinical trial lifestyle interventions 
Dr. Appel, a practicing internist, who will work with Drs. Daumit to promote and monitor safety throughout the 
study. The safety officer does not provide direct medical care and is not involved in the intervention.  
 
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. 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.   
 

 
22 
 
Physical activity: The small risk during physical activity will be minimized by emphasizing moderate activity, 
and by following American College of Sports Medicine guidelines regarding need for medical examination prior 
to beginning an exercise program. Trained exercise interventionists will supervise all exercise sessions.   
 
Nutrient intake: Calorie restriction could theoretically lead to inadequate nutrition or excessive, rapid weight 
loss.  Intervention subjects will be encouraged to eat a variety of foods from all food groups and maintain an 
adequate caloric level. Those who have a sudden, marked weight reduction will be interviewed to determine if 
extreme measures have been taken.  The issue of adequate nutrient intake and the importance of safe weight 
loss will be discussed in the group and individual sessions.  If a problem is suspected, the participant will be 
counseled.   
 
Hypoglycemia related to diet and exercise interventions: For patients who may be susceptible to 
hypoglycemia due to use of anti-diabetic medications, weight loss interventions have the potential to increase 
the risk of hypoglycemia, especially during the time when diet and/or physical activity interventions are 
implemented.  To minimize the risk of hypoglycemia, we will require primary care physician approval prior to 
enrolling individuals with diabetes.  
 
Symptomatic hypotension related to diet and exercise interventions: For patients who may be susceptible 
to hypotension because they are using medications that lower blood pressure, weight loss interventions have 
the potential to increase the risk of hypotension.  Participants are educated about symptoms of hypotension 
and urged to contact their primary physician if they have symptoms suggestive of hypotension.  In addition, 
staff will notify primary physicians for participants who develop symptomatic hypotension while on anti-
hypertensive medications.  
 
Alert Values for baseline blood pressure data collection 
Blood pressure:  Alert level 1: For any systolic blood pressure (SBP) measure of >= 180 mmHg or diastolic 
blood pressure (DBP) of >=110, the participant is notified during the visit, the study clinician is contacted and 
the subject is referred to their personal physician for further evaluation within one week.  Alert level 2: For any 
systolic blood pressure (SBP) measure of >= 160 mmHg or diastolic blood pressure (DBP) of >=100, the 
participant is notified during the visit, the study clinician is contacted within 1 week and the subject is referred 
to their personal physician for further evaluation within one month. Alert level 3: For any systolic blood pressure 
(SBP) measure of >= 140 mmHg or diastolic blood pressure (DBP) of >=90, the participant is notified during 
the visit, the study clinician is contacted per routine reporting and the subject is referred to their personal 
physician for further evaluation within two months.  For any elevated blood pressure values, if the participant is 
symptomatic with chest pain, headache or shortness of breath, the study clinician and primary care physician 
are notified immediately.  For any systolic blood pressure (SBP) measure of <90 mmHg or diastolic blood 
pressure (DBP) of <50, the participant is notified during the visit, the study clinician is contacted per and the 
subject is referred to their personal physician for further evaluation within one week.  If the participant has 
symptoms of lightheadedness or feeling faint, the study clinician and primary care physician are notified 
immediately. 
 
Mental Health  
If a participant is hospitalized for psychiatric reasons during the study, he/she will be reassessed by 
rehabilitation program staff and study personnel after return to the rehabilitation program for the ability to 
continue in the curriculum. We have enrolled over 800 people from a similar population in clinical trials, and we 
expect these occurrences to be rare.  
 
Pregnancy and other exclusions 
If a participant becomes pregnant during the study, she is then excluded. If a participant develops cancer, 
unstable angina, or another condition for which weight loss or exercise might be contraindicated, further 
participation will be determined by the participant’s primary care physician in conjunction with a study clinician. 
 
Surveillance and Reporting Procedures 

 
23 
 
Serious adverse events include the following: death, life-threatening experience, inpatient medical or surgical 
hospitalization, persistent or significant disability or incapacity.  Important medical events that do not result in 
death or require hospitalization may be considered serious adverse events if they jeopardize the participant or 
require medical or surgical intervention to prevent one of the outcomes above.   
 
Breach of confidentiality 
All participant information will be considered confidential. This confidentiality will be assured through several 
mechanisms. For the study, each participant will be assigned an anonymous study ID, which will be used on all 
study forms. In addition, all study forms and paper records that contain participant information will be kept in 
secured, locked areas when not in use. During active data collection, any hard copies of data collection forms 
will be stored in locked areas. Only authorized personnel will have access to these locked areas.  Finally, 
neither the rehabilitation program nor participants will be identified by name in any publications.   
 
For qualitative data, no focus group participants will be individually identified; a site identifier will be used.  The 
link to the site ID will be held in a locked file. Focus group transcripts will have names (if mentioned during the 
group) removed, and no participants will be identified by name in any publications. The tapes will be kept for 7 
years and then destroyed. Furthermore, data will not be presented in such a way that identity can be inferred. 
Transcripts of focus groups will have names removed. Employees will be assured that their participation in the 
study and information shared in the interviews will not affect their employment or their evaluation. As described 
in Data Management and Security, data will be stored in Johns Hopkins secure drives. 
 
17. BENEFITS 
 
There may be no benefit to individual participants. The research will help us understand the effets of the pilot 
implementation intervention on mental health program staff delivery of the curriculum in psychiatric 
rehabilitation program settings.  
 
 
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