Technology-Assisted Weight Management Intervention Within Patient-Centered Medical Homes: The GEM (Goals for Eating and Moving) Study
Phase: NA
Conditions: Weight Gain, Obesity
Sponsor: NYU Langone Health

 
 
Official Title: 
Technology-Assisted Weight Management Intervention Within Patient-
Centered Medical Homes: The GEM (Goals for Eating and Moving) 
Study   
NCT Number: 
NCT03006328 
Study Number: 
16-01445 
Document Type:  
Study Protocol and Statistical Analysis Plan 
Date of the 
Document: 
• 
December 15, 2020 
 

The GEM Intervention: Goals for Eating and Moving 
Project #i16-01445 / Version date 12/02/2020 
 
 
 
 
 
 
The GEM Intervention: Goals for Eating and Moving 
A technology-assisted 5As-based intervention for Medical Homes to promote weight 
loss, behavior change, and participation in intensive weight management programs. 
 
 
 
 
Principal Investigator: 
Melanie Jay, MD, MS 
Assistant Professor 
Department of Medicine, Division of General Internal 
Medicine 
New York University School of Medicine 
227 E 30th Street, 6th Floor 
New York, NY 10016 
212-263-4169 
 
Co- Investigators:  
 
 
 
 
 
Protocol Number: 
 
Judith Wylie-Rosett, EdD, RD 
Atran Foundation Chair in Social Medicine 
Professor and Division Head 
Department of Epidemiology and Population Health 
Albert Einstein College of Medicine 
1300 Morris Park Avenue 
Bronx, NY 10461 
718-430-3345 
 
 
 
 
 
Initial version: 
 
                   07/26/2016 
Version 2:  
 
 
        06/26/2017 
Version 3:  
 
   
        08/02/2017 
Version 4: 
 
 
        12/12/2017 
Version 5:  
 
 
 
03/14/2018 
Version 6:  
 
 
 
02/14/2020 
Version 7: 
 
 
 
06/19/2020Version 8: 
 
 
 
12/02/2020 
 
 
 
 
 
 

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I. Purpose of the Study  
Brief Background and Rationale  
Over 35% of adults in the United States are obese, with increased risk of diabetes, 
hypertension, and hyperlipidemia.1,2  However, there are few primary care (PC)-based 
weight management interventions for this population. Modest weight loss improves health 
and prevents chronic disease, but healthcare teams often fail to counsel patients about 
their weight due to barriers such as competing demands and poor competency. Thus, 
PC-based weight management interventions are needed to address the needs of adults 
with obesity and support healthcare teams to improve care.  
With funding from a Career Development Award from the Veteran’s Affairs (VA) and 
rigorous formative research, we developed a technology-assisted weight management 
intervention, called Goals for Eating and Moving (GEM). This intervention is based on the 
5As framework (assess, advise, agree, assist, arrange) as recommended by the United 
States Preventive Services Task Force and reimbursed by the Centers for Medicare and 
Medicaid Services. The GEM intervention uses a tablet-delivered online tool to facilitate 
in-person and telephone-delivered health coaching by non-clinical staff, provide tailored 
patient education materials, and activate patients to set behavior change goals and 
discuss weight management treatments with their healthcare teams. Preliminary data 
suggests that the GEM intervention is feasible and acceptable to Veterans and VA staff 
and facilitates 5As counseling. An ongoing RCT will determine if it promotes weight loss.  
The Patient-Centered Medical Home model is an expanded care model emphasizing 
patient-centered care delivered by inter-professional teams of individuals working to 
integrate evidence based approaches to improve individual and population health.14,15 
However, it is unclear how the Patient-Centered Medical Home model can be used to 
address barriers to 5As implementation, improve weight management counseling, and 
increase participation in intensive weight management programs. We developed GEM 
(Goals for Eating and Moving), an innovative, technology-assisted 5As-based 
intervention for Medical Homes to promote weight loss, behavior change, and 
participation in intensive weight management programs. To establish the efficacy of the 
GEM intervention, we will conduct a cluster randomized controlled 12-month intervention 
of 16 primary care teams at two urban healthcare systems with Medical Home models of 
care to compare the GEM intervention (intervention arm) with Enhanced Usual Care 
(educational materials; control arm).  
Specific Aims  

3 
 
 
 
1. Test the impact of the GEM intervention on weight change, and clinical and behavioral 
outcomes. 
2. Identify predictors of weight loss in the GEM intervention arm related to: a) goal-
setting processes and b) intervention components 
3. Determine the impact of the GEM intervention on obesity-related counseling practices 
and attitudes in primary care providers.  
Hypothesis  
The patients within primary care teams randomized to the Goals for Eating and Moving 
(GEM) intervention will have greater weight loss than those who receive Enhanced Usual 
Care.  
Research Design  
a. We will conduct a cluster-randomized controlled trial of the GEM intervention at 
two healthcare systems in New York City: The VA New York Harbor Healthcare 
System (Manhattan campuse) and Montefiore Medical Groups (4 sites affiliated 
with New York City Research and Improvement Networking practice-based 
research network).  
 
b. We will conduct a RE-AIM (reach, efficacy, adoption, implementation, and 
maintenance) evaluation of the GEM intervention. 20 
 
c. We will explore potential effects of secondary measures such as perceived 
procedural fairness or experiences of discrimination on health outcomes and 
weight-loss behaviors including but not limited to dietary behaviors, physical 
activity, and quality of life measures.  
Background  
Modest weight loss (7%) via the Diabetes Prevention Program (DPP) can reduce the risk 
of diabetes in high-risk patients by 58%. 3 Similarly, all Veterans Affairs (VA) Medical 
Centers offer the MOVE! program, a lifestyle-based program delivered in small group 
sessions. 4, 26, 27 One report found that patients who attended two or more MOVE! 
sessions were more likely than matched controls to have clinically significant (>5%) 
weight loss ad less likely to gain weight. 28 Unfortunately, intensive lifestyle programs like 
this are not available to most primary care patients and very few studies have looked at 
interventions to treat obesity in the primary care setting,29-30 despite the obvious need for 
improving delivery of obesity care. We need to test more robust strategies to increase 
participation in these effective programs.  
The primary care setting is critical to reducing the burden of obesity. Primary care (PC) is 
an important venue to promote weight loss through lifestyle behavior change, and 
effective PC-based interventions can potentially have a significant public health impact, 

4 
 
 
 
since the majority of the 1 billion yearly ambulatory visits are made to primary care 
physicians. 9 Moreover, physicians’ and other providers’ counseling is associated with 
positive behavioral and weight-loss outcomes.
31-34 The United States Preventive Services 
Task Force endorses the use of the 5As framework (Assess, Advise, Agree, Assist, 
Arrange) to deliver obesity counseling within primary care.
35 While Medicare reimburses 
providers for 5As weight management counseling, providers frequently fail to effectively 
counsel obese patients to lose weight. 33, 36 This has been attributed to lack of training,
34,37 
poor competency,
38 perceived lack of effectiveness,
39 and competing demands on time 
during the medical visit.
40 Thus, more studies are needed to determine the best way to 
integrate weight management into primary care practice.  
With funding from a Career Development Award (CDA) from the Veterans Affairs, we 
recently developed a technology-assisted, weight management intervention called Goals 
for Eating and Moving (GEM) to deliver 5As weight management counseling within a 
patient centered medical home model of care (PCMH). Figure 1 illustrates how the 
intervention is delivered within PCMH and promotes goal setting and weight loss. Patients 
arrive early to their PC appointment to use an online goal setting tool (GEM tool) delivered 
on a tablet computer that generates a personalized binder of tailored materials. The 
patient then meets with a health coach to further refine weight loss and lifestyle goals, 
address barriers, and suggest other weight management resources. PC teams then 
endorse goals and provide brief motivational interviewing as needed. They can use a 
clinical reminder within the electronic health record to document 5As counseling 
conversations. Patients receive follow-up phone coaching calls from their health coach to 
document progress, adjust goals, and facilitate communication with the heath care team 
and weight management-related services.  
The GEM intervention has great potential to improve the delivery of obesity counseling 
within the PCMH model of primary care. Initial findings from an ongoing pilot study of this 
intervention among Veterans and PC staff at a VA medical center demonstrated that it 
was feasible and acceptable to Veterans and staff and facilitated goal-setting 
conversations (see Preliminary Studies). However, there is no standard by which to 
leverage the Patient-Centered Medical Home model to provide weight management care. 
There is a need to test weight management interventions within patient-centered medical 
homes that integrate and/or partner with effective, intensive programs such as MOVE! 
and DPP.  
Judith Wylie-Rosett, EdD, RD (Co-I) has over three decades of experience leading 
multicenter and investigator-initiated lifestyle trials for diet, obesity, and exercise whose 
work in Diabetes Prevention Program (DPP), DDP-Outcomes Study and Women’s Health 
Initiative has shaped national health guidelines. 52-56 
 
 
Study Design  
We will conduct this study using 3 steps:  

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1. Test the impact of the GEM Intervention on weight change, and clinical and 
behavioral outcomes. 
a. We will obtain weight and height measurements, waist circumference 
measurements, , and blood pressure measurements from patients at 
multiple time points throughout the study. We will also use questionnaires 
to measure dietary outcomes and physical activity outcomes. Finally, 
electronic health records (EHR) and surveys will be utilized to evaluate 
attendance to intensive weight management programs. 85, 96, 86, 97, 98. 99, 100, 
101, 102 
 
2. Identify predictors of weight loss in the GEM intervention arm related to: a) goal-
setting processes and b) intervention components.  
a. We will measure attainment of behavioral goals by asking patients to 
report on how many days in the past week they achieved each of their 
SMART goals. 88 We will record the number of telephone coaching calls 
received by patients within the research study database and measure the 
frequency of counseling by running a clinical reminder report and 
conducting electronic chart reviews.  
 
3. Determine the impact of the GEM intervention on obesity-related counseling 
practices and attitudes in primary care providers.  
a. We will survey providers to measure 5As-related competency and 
attitudes about weight loss using validated survey items. 13 The feasibility 
and acceptability of the intervention will be evaluated using RE-AIM 
analysis.  
 
II. Characteristics of the Research Population  
 
Number of Subjects 
With an expected 20% participation rate (based on pilot data) and a 75% retention rate 
(based on rates from another VA study and other technology-based interventions)49,69, 
we will need to screen 2,615 eligible patients to enroll a baseline sample of 512 patients 
and end with 384 patients completing the study.  
 
Gender of Subjects 
Both male and female patients will be recruited as part of the weight management study 
being tested, and the study is not intended to be gender specific.  Often, weight 
management studies include 70-80% women,96 and men are often under-represented.  
However, we anticipate that 52% of our sample will be women since the VA has only 8-
10% women. 
 
 
Age of Subjects 
Subjects between the ages of 18 and 69 years of age are eligible to participate in the 
study. The research study is not being conducted with children and thus subjects must 

6 
 
 
 
be at least 18 years of age.  We are not including individuals older than 69 years of age 
as the published evidence is unclear whether weight loss should be a treatment strategy 
for obese older adults and also whether obesity might be protective against mortality in 
seniors. 109 
 
Racial and Ethnic Origin 
We will not exclude any human subject based on race or ethnicity. 
 
The following list the inclusion and exclusion criteria for our study population. 
 
Inclusion Criteria 
 Between the ages of 18-69 years of age, 
 Body mass index of ≥30kg/m2 OR  
 Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity67,68 
 Hypertension 
 High Cholesterol 
 Sleep Apnea 
 Osteoarthritis 
 Metabolic Syndrome 
 Under primary care team care with at least one prior visit with their provider in the 
past 24 months 
 Access to a telephone, and ability to travel for in-person evaluations at baseline, 
6, 12, and 24 months (optional for follow-up) 
 
The BMI inclusion criteria aim to include participants with overweight/obesity. Those 
patients who are overweight should have obesity co-morbidity as this is an at-risk 
population for negative health conditions, similar to those with obesity.  
 
Exclusion Criteria 
 Patients who do not speak English or Spanish, 
 Have active psychosis or require antipsychotic medication, psychoactive 
substance use, chronic rheumatic heart disease, other diseases of endocardium 
and cardiac dysrhythmia, Parkinson’s disease, diabetes, or other cognitive issues 
 Participated in MOVE!, DPP, or another intensive weight management program 
(>4 sessions) in the past year, 
 Have a history of bariatric surgery, 
 Are pregnant, breastfeeding or become pregnant during the intervention period, 
 Have a provider who states they should not participate, 
 Have self-reported inability to read at 5th grade level. 
 Currently take weight-loss medications or diabetes medication that may impact 
weight change 
 Receive chemotherapy or cancer treatment  
 Had metastatic cancer in the last 6 months 
 Does not want to lose weight 
 

7 
 
 
 
We are excluding individuals with any of the above listed conditions as this will likely 
impact their ability to fully participate in this study. Additionally, some of these listed health 
conditions may limit physical activity. As this intervention includes telephone weight 
management counseling and reviewing of printed weight management materials, we are 
excluding participants without a telephone or participants who cannot read material 
written at the 5th grade level or above. 
We will use phone screen and EHR information to verify inclusion and exclusion criteria. 
Vulnerable Subjects 
No vulnerable populations will be included as part of this weight management intervention 
study.  
 
 
III. Methods and Procedures 
 
We will conduct a cluster-randomized controlled trial of the GEM intervention at two 
healthcare systems in New York City: The VA New York Harbor Healthcare System 
(Manhattan campus) and Montefiore Medical Group (4 sites affiliated with New York City 
Research and Improvement Networking (NYC RING) practice-based research network. 
Participants will be randomized at the team level (19 teams with approximately 28 
providers and 512 patients to achieve a sample size of 384 patients at 12 month follow-
up for the primary outcome assessment).  The primary care teams will be randomized 
using a random number generator (block randomization with block size of four) to either 
the GEM Intervention or Enhanced Usual Care arms. Randomization will be stratified by 
healthcare system (MMG and VA). 
 
Intervention Arm – GEM  
The GEM intervention leverages the patient-centered medical home model (see Figure 1 
below) by using the GEM tool to provide individually tailored, patient-centered care at the 
time of the primary care visit, promote standardized weight management counseling by 
health coaches and primary team members, coordinate care between teams and other 
weight management service providers/programs (e.g., dietitians, health educators, 
DPP), and provide feedback to the provider and primary care team about patients’ weight 
management-related goals, progress, and care.  Patients in the GEM intervention will 
complete the following (items 1–2 will be completed at the baseline visit). Average times 
to complete are included below based on pilot testing. 
1. Complete the GEM tool (20 minutes) 
2. Meet with a health coach and review tailored patient report and educational 
materials (30 minutes) 
3. Meet with their primary care team for regularly scheduled visit (varies 15–45 
minutes, 1–8 times/year) 
4. Receive 12 telephone coaching calls from health coach (20–30 minutes each) 
5. Follow up as needed with primary care teams (varies) 
 

8 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
GEM 
Tool: 
If 
needed, 
health coaches will help patients to 
use the GEM tool. The online 
program is optimized for use on 
tablet computers and designed to 
support health coach and primary 
care team counseling. It assesses 
current behaviors, barriers, and 
facilitators to weight loss via a 16-
item 
questionnaire, 
provides 
tailored advice, and guides patients 
to set weight loss (5–10%)10, diet, 
and physical activity (PA) goals. It 
identifies intensive weight management programs and self-monitoring options, 
allowing patients to choose which to discuss with the health coach and primary care 
team. This tool also generates an individualized patient report, provides tailored 
educational materials, and produces a report for the primary care team through the 
EHR. Although developed initially for the VA, it can be customized for other healthcare 
systems with minimal programming.  
 
 Baseline Health Coach Visit: After completing the GEM tool, a Health Coach meets 
with the patient for 30 minutes (based on our pilot study). Sessions will be audio-
recorded for fidelity checks and health coach training.  The Health Coaches will 
perform the following tasks:  
 Make initial goals into SMART (Specific, Measurable, Attainable, Relevant, Timely) 
goals63  
 Encourage participation (using MI) in MOVE, DPP, or community-based 
programs/gyms 
 Teach how to self-monitor weight, diet, and PA behaviors via pedometer, food log, 
and/or weight management apps (e.g. MOVE! Coach mobile70,71 on iPhones, My 
Fitness Pal72 on Androids)  
Figure 1: How GEM intervention fits within PCMH 
 

9 
 
 
 
 Provide brief MI and Brief Action Planning73 to address barriers and increase 
patient self-efficacy  
 Facilitate meetings with extended team members (e.g. health educators, dietitians, 
primary care physicians) if needed 
 Enter a report for primary care teams into EHR from the GEM tool 
 Communicate potential barriers/concerns to the team at baseline visit and as 
needed throughout the intervention period (e.g., via EHR notes, secure messaging 
system, telephone, and/or team meetings) 
 
 Telephone Coaching: To achieve sufficient intensity according to USPSTF 
guidelines,10 we will incorporate 12 telephone coaching calls by a health coach over 
12 months. Scheduled calls will occur every 2 weeks (biweekly) for months 1–3, 
monthly for months 4–6, and every other month (bimonthly) for months 7–12. GEM 
Intervention arm patients will receive a reminder call or an electronic reminder via 
MyHealtheVet or VA’s Annie texting service to self-monitor their weight, food intake, 
and PA for at least 3 days prior to the coaching call. Studies suggest that episodes of 
short, consistent self-monitoring (for 3 days) reduce weight and may improve 
adherence.74 Health coaches will use self-reported self-monitoring data  (from 
pedometers, food logs, and smart phone apps) to determine goal adherence and 
counsel patients to encourage small changes.49 Health coaches will document 
sessions in REDCap, help patients create new goals when appropriate, and use MI 
techniques to address barriers to behavior change. Patients will be able to contact 
health coaches via telephone for additional support. Patients will be reminded to 
discuss their goals during their next primary care visit (if scheduled). 
 
 Provider Role: Providers in the GEM arm will provide 3–5 minutes of counseling, use 
clinical reminders to document this counseling, provide brief MI to address barriers 
(depending on time and patient needs), and discuss GEM-generated weight 
management goals during future visits.  The GEM tool creates a report to 
communicate data to the participant’s primary care team and generates a clinical 
reminder which facilitates documentation of primary team goal setting conversations 
and counseling.  
 
Control Arm – Enhanced Usual Care (EUC)  
Patients in the EUC arm will receive non-tailored weight management handouts by health 
coaches (Health Bulletins from the NYC DOHMH).79–81 Patients will follow-up with their 
primary care teams as needed.  
 
Data Collection 
Patients: Assessment will occur at the following time points: 
 At Baseline, 6, 12, and 24 months, patients will meet in-person or over the phone (for 
follow-up) with a research assistant (RA) to complete surveys; measure weight, 
height, blood pressure, and waist circumference. Baseline surveys will include a pre-
survey (completed before receiving GEM Intervention/Enhanced Usual Care). 
Electronic chart review will also occur at these time points.  The RA will administer all 
surveys and enter the data directly into our REDCap database. To compensate for 

10 
 
 
 
travel and time spent completing study measurements, patients will be given $25 
dollars for the baseline study visit, $30 dollars for the 6-month study visit, $40 dollars 
for the 12-month study visit, and $50 for the follow-up 24-month visit and $20 dollars 
for the optional one hour opinion session and 2 follow-up phone calls. During the 
baseline visit we will encourage patients to sign-up for MyHealtheVet, if they haven’t 
done. In addition, we will inform patients about the VA’s secure Annie texting service 
and help them to sign up, if requested, as another option to receive reminder text 
messages for appointmentsIf patients are signed-up for MyHealtheVet, they can 
choose to receive reminders for their upcoming study visits or health coach phone 
calls electronically via myHealtheVet. Alternatively, patients can choose receive 
reminder phone calls from secure VA phones lines or via the secure Cisco Jabber 
application.. Before upcoming phone coaching calls and study visits, we will send 
reminders via the secure messaging system MyhealtheVet, VA’s Annie texting service  
or make phone calls via secure VA phone lines or via the secure Cisco Jabber 
application. 
 When performing telephone Coaching Calls (patients in GEM Intervention arm only), 
Health coaches will use a counseling tool that also facilitates data collection into 
REDCap database.  
 Chart reviews 12 and 24 months post-baseline visit to explore maintenance of 
counseling post-intervention  
 
Primary Care Teams: At 12 months, we will give surveys to providers, which will be 
administered in paper and then entered into our REDCap database. Alternatively, we will 
administer the provider survey online via REDCap. Furthermore, we will conduct 
qualitative interviews, and audiotape select visits.  
 
Future Directions: In future versions of the GEM intervention we would like to add a 
visualization technique called Mental Contrasting with Implementation Intentions (MCII) 
that is utilized through an exercise called WOOP (Wish, Outcome, Obstacle, Plan). MCII 
is a novel, practical strategy that was developed and tested through 20+ years of research 
to promote motivation and behavior change, particularly for challenging behaviors.110-115 
In order to obtain data on feasibility and acceptability among Veterans without introducing 
the burden of an additional visit, we will invite up to 20 participants in either arm at the 
Manhattan VA site to participate in an optional one hour session at their 24 month visit 
for an additional $20. Veterans that agree to this additional session will be reconsented 
with the revised consent form describing this session. During this session they will receive 
training on WOOP and will be shown how to use the free downloadable WOOP app.24 
We will then ask them to share their opinions on WOOP and the app. We will not collect 
any information from the WOOP app and discussed this piece of the protocol with the 
Privacy Officers (Lindsay Dean and Chrissie Palividas). In addition to this training, we will 
ask each participant a few brief questions related to goal commitment and stage of 
change before and after the WOOP training. We will also ask permission to follow up via 
telephone at 3 days and 1 month after the training to see if they have used the technique 
to make any changes related to weight, diet or physical activity. The materials for this 
session can be found in Appendix F. 
 

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Data Analysis and Data Monitoring  
First, all the variables will be summarized (intention-to-treat approach) using mean (with 
standard deviation) and median (with interquartile range for continuous variables and 
frequency table for categorical variables) overall and by interventions arms, respectively. 
Then, Mann-Whitney tests for continuous variables and Fisher’s exact tests for 
categorical variables will be used to check if both providers’ and patients’ baseline 
characteristics are balanced between the interventions arms.  
 
Impact of the GEM intervention on weight change, and clinical and behavioral outcomes: 
The primary outcome is mean weight loss at 12 months. Mann-Whitney tests for 
continuous outcomes (e.g., weight loss) and Fisher’s exact tests for categorical outcomes 
(e.g., whether or not patients achieve ≥5% weight loss) will be used to compare the two 
intervention arms at 12 months. Unadjusted confidence intervals will be computed to 
compare the effects of the GEM intervention on outcomes with the effects of enhanced 
usual care on outcomes. Moreover, we will use repeated measures modeling, based on 
mixed models, to compare outcome variables between intervention arms, using all the 
data at baseline and three follow-up visits. Such modeling can adjust for baseline 
characteristics (e.g. diabetes, gender), taking into account: a) the correlation among 
patients within providers, and b) the correlation among repeated measures within 
patients. Model-based adjusted confidence intervals will be provided to also measure the 
effects of the intervention on outcomes. Although the repeated measures modeling can 
address missing data automatically, assuming it is missing at random, we will further use 
a multiple imputation procedure to conduct sensitivity analyses under the assumption of 
missing data not at not at random. The sensitivity analyses will use pattern-mixture 
models to examine if the statistical findings are robust across several scenarios, including 
the least-favorable scenario where the missing data from the GEM intervention arm 
follows the same pattern as that of the observed data from the usual care arm.  
 
Predictors of weight loss in the GEM intervention arm related to: a) goal setting processes 
and b) intervention components: We will use visualization tools, such as scatterplots and 
descriptive analyses (e.g., Spearman correlation coefficients) to display the association 
between weight change and potential predictors. Multivariate regression models will be 
used to examine the effects of those predictors, which we suspect will be associated with 
weight loss in the intervention arm. Multivariate linear regression models will be 
considered for continuous outcomes and multiple logistic regression models will be 
considered for binary outcomes. Missing data will be dealt with using inverse-probability-
weighted methods.   
 
Impact of the GEM Intervention on obesity-related counseling practices and attitudes in 
primary care providers: We will use Mann-Whitney tests for continuous provider-level 
outcomes and Fisher’s exact tests for categorical provider-level outcomes to compare the 
two intervention arms at each survey. Confidence intervals of the effects will also be 
computed.   
 
Data Monitoring: There will be no formal data and safety monitoring board for this 

12 
 
 
 
protocol as there is only minimal risk associated with participation in the current study. 
The PI will monitor data and safety. Should unanticipated reportable events occur, 
defined as internal or external events (such as deaths, life-threatening experiences, 
injuries, breaches of confidentiality, or other problems) any time during or after the 
research study, which in the opinion of the PI are unanticipated, the PI will report 
them immediately to the NYU IRB. Any new information indicating a change to the 
risks or potential benefits of the research, any deviation from the protocol, and any 
possible serious or continued non-compliance will be reported to the NYU IRB by the 
principal investigator immediately. 
 
Data Storage and Confidentiality  
Storage of Subject Data: All subject data collected from the GEM online tool including 
survey responses and recording of responses while using the tool, interviews, focus 
groups, pre/post surveys, and measurements will be kept confidential and anonymous 
through de-identification. This signifies that subject names, dates of birth, and primary care 
provider names will be de-identified both in audio and written script during the transcription, 
segmentation, and coding process. Study session data will be entered into REDCap, 
which is a password-protected database. Subjects will each be given a study identification 
number, which will be stored in the password-protected database. Patient identifying 
information (e.g. subject name and date of birth) will be maintained REDCap, which is a 
password-protected database. All paper data will be kept in a locked, fire-proof file cabinet 
dedicated to the study that is kept in one of the study team’s locked offices (15028BN, 
15028AN 15028CN, or 15161N at the Manhattan VA). 
Access to Subject Data: Only IRB-approved study personnel, including the Principal 
Investigator, Co-Investigators, Research Coordinator, and other research staff, will have 
access to the data for entry and analysis. Healthcare providers who are not key personnel 
will not be informed of any responses given by subjects during the study visit. 
Retention of Subject Data: Subject data will be kept throughout the duration of the study 
and after the study has concluded to continue with data analysis. When data is no longer 
needed it will be disposed of appropriately via shredder in order to continue protecting 
subject confidentiality and anonymity. 
 
 
IV. Risk/Benefit Assessment 
 
Risk 
Any research study has possible risks and discomfort and on a rare occasion, unknown 
and unforeseeable (unanticipated) risks may also occur. Participation in the study poses 
no more than minimal risks to the subject’s physical and mental health as well as 
personally identifiable information. Subjects may experience frustration that is often 
experienced when completing surveys. Some questions may be of a sensitive nature, 
and subjects may therefore become distressed as a result. If, however, subjects 
become distressed by a question, subjects have the right to stop at any time or choose 
not to answer a question or certain questions.  
 

13 
 
 
 
The research team understands that discussing topics related to weight, diet, physical 
activity, and/or an individual’s experiences with these topics can be emotional given the 
stigma surrounding obesity and its associated medical problems within society.  
 
 
Protection against Risks 
All members of the research team have been extensively trained in order to effectively 
facilitate conversations and minimize the level of discomfort that individuals may face 
when dealing with sensitive topics throughout the duration of the study. In addition, any 
potential behavioral changes related to diet or physical activity will be assessed and 
approved beforehand by properly trained individuals, which include the Principal 
Investigator, Co-Investigators, Research Coordinator, and other research staff.  
 
To assure the minimization of any risks all aspects of the research study will be 
conducted in a private and safe setting. Subjects may withdraw from the study at any 
given point without having their regular care impacted at the VA or MMG. Protection 
against the loss of confidentiality will occur through securing all subject data in a locked 
study office and in a database that is on password-protected computer. As for 
employees who are participating, this research involves minimal risk for physical, 
psychological, social, and economic harm. 
 
Potential Benefits to the Subjects 
 Patients: The patients who participate in the study will have the opportunity to 
receive weight management information and set lifestyle behavior change goals to 
improve their diet and increase physical activity, which may lead to weight loss and 
improved health outcomes. Even for patients who do not change their health 
behaviors, talking about these topics with trained researchers could serve as support 
or motivation to move them closer to doing so in the future. 
 Providers, , and other VA or Montefiore employees:  Employees who participate 
in the study may gain improved obesity-related knowledge and patient counseling 
skills, which could enhance their career, job performance, and 
satisfaction. Specifically, employees may have the opportunity to receive (additional) 
training in 5As weight management counseling and practice brief motivational 
interviewing. Training in these could help to facilitate and/or improve discussions 
around weight management and health behavior change with patients, as well as 
encourage the use of individualized techniques to improve diet and exercise and 
setting health behavior change goals with patients. 
 
V. Investigator’s Qualifications and Experience 
 
The CV for each key personnel involved in the study is included in the IRB submission. 
Modifications will be made when Research Assistants and Health Coaches are on-
boarded. All key personnel have (or will have) completed online training in the 
protection of human subjects. 
 
Summary of Research Personnel and Main Roles: 

14 
 
 
 
 Principal Investigator/Project Coordinator: oversees project implementation 
 Dr. Melanie Jay (PI) 
 Sandra Wittleder (Project Manager) 
 Victoria Sweat (Program Manager) 
 Co-Investigators/Other significant contributors 
 Dr. Judith Wylie-Rosett: Health behavior Intervention expertise  
 Research Staff 
 Research Assistants: Consenting, data management, protocol fidelity 
 Health Coaches: Health coaching patients and data collection 
 
VI. Subject Identification, Recruitment, and Consent/Assent 
 
Method of Subject Identification and Recruitment 
 Primary Care Teams – Primary care teams at each site that meet the eligibility criteria 
below will be separately assigned a number using a random number generator, and 
the first seven teams selected at each site will enroll in the study for a total of 19 
primary care teams (11 VA and 8 MMG). Individual providers will be allowed to opt out 
of the study. We do not anticipate that providers will drop out once enrolled, based on 
the VA PROVE study where all 18 eligible teams and 51/52 providers participated for 
the duration of the study.65 While pods (at MMG) and PACTs (at VA) have variable 
numbers of providers and patients, we will recruit 2-3 providers from each team prior 
to randomization to ensure similar numbers of teams, providers, and patients in each 
arm. Table 2 (below) provides an overview of the staffing/patient population for each 
site. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 2: Description of PC staffing and patient populations at each of 
the VA and MMG sites (Data from the VA PC Almanac as of May 2015 or 
from MMG site director budget reports) 
Site 
#Tea
ms 
(Pods 
or 
PACT
s) 
# 
Provid
ers 
Total # 
Patient
s in PC 
% 
Obes
e 
% 
Femal
e 
% 
Hispanic 
or Latino 
VA Brooklyn 
12 
24 
13,219 
32.7 
11% 
21% 
VA Manhattan 
11 
28 
13,813 
26.7 
8% 
MMG Bronx East 
3 
17 
24,917 
47.0 
62% 
38% 
MMG 
Grand 
Concourse 
2 
11 
17,841 
41.0 
67% 
40% 
MMG 
University 
Avenue 
2 
9 
3,679 
42.0 
58% 
79% 
MMG Castle Hill 
1 
7 
6,079 
45.6 
59% 
58% 

15 
 
 
 
 Patient Recruitment (Figure 2 below) – Using the Patients Health Information 
Systems and Technology Architecture (VistA), the VA’s Health Information 
Technology system, and the Montefiore EPIC and Clinical Looking Glass systems, we 
will identify patients with upcoming primary care appointments who meet the eligibility 
criteria.  A Research Assistant (RA) will confirm eligibility by EHR and provider review.  
One to two weeks before their baseline visit, eligible participants will be sent a letter 
signed by both the Principal Investigator (PI) and giving them the opportunity to opt 
out (i.e., request to not be contacted). The RA will call patients to recruit, screen for 
eligibility, and schedule the baseline. This allows enough time for all intervention 
components to be completed, and is responsive to patient scheduling preferences 
expressed in a similar recruitment strategy used in the VA PROVE study65 and our 
pilot studies.  
Eligibility will be based on the inclusion and exclusion criteria established for the study. 
Participation in the study is completely voluntary and all prospective subjects may 
refuse to participate or withdraw from the study at any given time.  
 
 
 
 
 
Process of Consent 
Consent will be obtained by a 
research assistant trained in 
consenting protocols. Once subjects 
have been identified as eligible, the 
study will be described in detail and 
informed consent will be obtained 
from subjects who wish to participate. 
An audio-video consent form will also 
be described in detail for subjects who 
agree to have their study session 
audio recorded.  
 
Subject Capacity 
In order for subjects to be eligible to 
participate in the study, subjects must 
have the capacity to give informed 
consent. Capacity will be assessed 
with the set of inclusion and exclusion 
criteria that has been established 
specifically for this study. In short, 
participants must be at least 18 years 
of age, have access to a telephone, 
be able to travel for in-person 
evaluations, and not currently have 
functional impairments that limit 
Figure 2: Recruitment and Eligibility Screening 

16 
 
 
 
physical activity.  
 
Subject/Representative Comprehension 
Research Assistants will be intensively trained in consenting protocols. RAs will assess 
comprehension by asking the subject whether the explanation of the information 
presented was understandable. The research assistant will be prepared to clearly 
summarize each section and will answer questions the subject may have about the 
consent forms. A copy of the consent form will be available for the patient to take home 
with them or will be  sent to them. 
 
Debriefing Procedures 
For this particular weight management intervention study, no information will be 
purposely withheld from any of the subjects who are recruited and/or are actively 
enrolled in the study.  
 
Consent Forms 
For the patient participants, two consent forms will be used: the research subject 
informed consent and audio-video consent forms.  For provider participants, completion 
of the survey will serve as implied consent. On the first page of the survey, it will 
explicitly state that participation is voluntary and that completion serves as consent. A 
waiver of documentation of informed consent was requested for the provider survey 
For provider participants, who chose to participate in qualitative interviews, we have a 
separate research subject informed consent form.  
 
Documentation of Consent 
Written consent will be obtained from all patient subjects who are eligible and agree to 
participate in the study and for provider subjects who chose to participate in qualitative 
interviews. Documentation of consent will be securely stored in the research team’s 
locked office on 15 North (15028CN) at the Manhattan VA Hospital.  
 
Costs to the Subject 
There will be no costs to the subjects for participating in this study. However, medical 
care and services provided by subjects’ current health care facility that are not part of 
the study, which includes normal visits and prescription expenses, may require 
payment. 
 
Payment for Participation 
To compensate for travel and time spent completing survey measures and basic 
measurements, study participants will be given cash or a ClinCard in the amount of 25 
dollars for the Baseline study visit, 30 dollars for the 6 month visit, 40 for the 12 month 
visit, and 50 dollars for the 24 month study visit and 20 dollars for the optional opinion 
session at the same 24 month study visit for up to a subset of 20 participants. This 
proposed payment is reasonable and commensurate with the expected contributions of 
participants and is meant to provide additional incentives for participants to complete all 
4 study visits. This amount of payment and the terms of the payment are included in the 
informed consent form. This payment is fair and appropriate and does not constitute 

17 
 
 
 
undue pressure or influence, or coercion of, the prospective research participant to 
volunteer for or continue participation in the research study. 

18 
 
 
 
VII. List of Appendices  
 
1. Appendix A - Recruitment Protocols and Materials* 
2. Appendix B – Data Collection Surveys* 
3. Appendix C - GEM Online Tool Screenshots* 
4. Appendix D – GEM Personalized Binder Materials 
5. Appendix E - Health Coaching Training Materials and Protocols* 
6.  Appendix F – WOOP Materials 
 
 
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