Increasing Uptake of Behavioral Weight Loss Programs Among Primary Care Patients
Phase: NA
Conditions: Obesity
Sponsor: University of Florida

Increasing uptake of behavioral weight loss programs among primary care patients Protocol 
NCT02708121 
6/5/2017 

Pro00079803 Your Wellness Prescription pilot trial 
PI: Megan McVay, PhD 
 
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Research Summary 
 
1.  Protocol Title: Your Wellness Prescription pilot trial 
 
2.  Purpose of the Study:  
Aim 1: Determine feasibility of conducting a cluster randomized trial testing a 
treatment initiation intervention in a primary care setting, as indicated by provider 
recruitment, patient recruitment, and study assessment retention. 
Aim 2: Determine intervention acceptability based on participant acceptability 
ratings and provider acceptability ratings. 
 
 
3.  Background & Significance:  
 
Behavioral weight loss programs produce clinically meaningful weight loss, 
reductions in the severity and incidence of some obesity comorbidities, and 
improvements in patients’ quality of life. Yet, behavioral weight loss programs are being 
initiated by only a small portion of adults with obesity (<10%). Important barriers to 
initiating programs are cost and availability; however, these barriers are diminishing as 
private and public health care payers have begun to offer evidence-based weight loss 
programs to insurees for free or at a low cost, a trend which is further supported by the 
2010 Affordable Care Act. However, initial evidence indicates that the availability of 
affordable programs does not automatically translate into increased program uptake. 
This suggests that factors other than cost and availability are important contributors to 
initiation of weight loss programs. Observational data suggests that weight loss 
treatment initiation is determined in part by psychosocial factors identified in the Health 
Belief Model (i.e., perceived severity, susceptibility, barriers, benefits, and self-efficacy), 
which can be targeted to increase initiation of weight loss treatment. 
An opportunity to increase initiation of weight loss treatment is present in the 
primary care encounter. Brief primary care weight counseling has been shown to 
increase patient motivation for weight loss. However, this rarely translates into significant 
weight reductions. It may be possible to achieve significant weight loss if this 
motivational opportunity was used to engage patients in evidence-based weight loss 
treatment. To do this, primary care weight counseling must address psychosocial 
determinants of treatment initiation. Given the limited time and other barriers to 
addressing these factors during the primary care appointment, it may be most effective 
and cost-efficient to target these factors with a web-based intervention that is completed 
by patients remotely, prior to their clinical visit. This intervention could target treatment 
initiation determinants and offer patients the opportunity to immediately enroll in weight 
loss treatment. For patients who are not responsive to initial intervention content (i.e., 
who do not immediately enroll in treatment), further content could be delivered to 
promote and assist patients in initiating an effective discussion about weight with their 
provider at their forthcoming clinical appointment. We are proposing a 
feasibility/acceptability pilot test of such an intervention. 
 
4.  Design & Procedures:  
 

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Design This is a parallel-arms pilot cluster randomized clinical trial. The unit of 
randomization is the primary care provider and the study arms are intervention and 
comparison. A 1:1 randomization allocation ratio will be used. 
Procedures. Up to six primary care providers will be recruited (see below for 
details). Once consented, providers will be randomized to the intervention or comparison 
condition. Patients who have clinical visits (index PCP visit) scheduled with enrolled 
providers will be identified, recruited, and consented prior to their appointments (see 
additional details below). We will recruit up to 12 patients per provider, for up to 72 total 
participants (with an intent of enrolling 60 total participants). Participants will be recruited 
for and enrolled in the study arm that their provider was assigned to.  
At the recruitment phone call, about half of the patients (determined by random 
assignment) will be informed that the study requires a baseline in-person assessment, 
and the other half will not be required to complete an in-person assessment. This is 
done to obtain important feasibility data about the impact on study enrollment of 
requesting an in-person baseline assessment session (in the context of a remotely 
delivered intervention). Having some participants attend an in-person session will also 
facilitate a comparison of clinically collected weight data and weight data collected by 
study research staff, which is also important for feasibility evaluation. 
All enrolled participants (comparison condition and intervention condition) will 
receive an email 4 to 14 days prior to their index PCP visit (with the optimal aim of 7-9 
days), which will contain either the intervention content or the comparison content 
(described in section 9 Study intervention).  
The assessments during the intervention will be as follows: 
Assessments 
Baseline assessment (patient). Half of the participants will attend an in-person 
baseline assessment and the other half will answer baseline questions by phone only. 
Baseline questions will primarily focus on individuals’ demographics and weight loss 
history. For individuals attending the in-person assessment, they will complete these 
questions in-person and we will obtain their height and weight (see Assessment Forms) 
Post-intervention acceptability assessment (patient). At the end of the web-based 
intervention there will be a link that directs intervention participants to a brief survey to 
obtain their opinion of the acceptability of the intervention (see Assessment Forms). 
Post-medical visit assessments (patient). The day of or day following participants’ 
index PCP visit, participants will receive an email that includes a link to questions about 
their experience at the primary care visit as it relates to weight and (for intervention 
participants) the intervention (see Assessment Forms). 
Provider interviews (provider). Within 1-2 weeks after each participant provider 
assigned to the intervention condition has completed all of his or her clinical appointment 
with all of the patient participants, intervention-condition provider participants will 
complete a 10-15 minute one-on-one phone interview to share their experience with the 
intervention. (see Assessment Forms for script) 
In-person six-month follow-up assessment (patient). Patient participants will 
complete an in-person follow-up assessment 6 months after study enrollment. We will 
measure weight, treatment use, and other relevant psychosocial factors. (see 
Assessment Forms). 
Six-month data obtained from weight loss programs. Data will be obtained by 
study staff on patient attendance for participants who enroll in the Track weight loss 
programs that (see Intervention section for details on this program, and Data Plan for 
data sharing information). 
Six-month data from clinical records. A pull of data from Epic (either via Deduce or 
manually) will be conducted at six months to obtain weight data (up to 6 months prior to 

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study enrollment and 2 years after study enrollment) and number of primary care 
appointments attended. Progress notes from encounters with PCPs from time of study 
enrollment to up to 1 year will be examined to abstract any documentation of weight-
related discussions.  
 
 
5.  Selection of Subjects: Selection criteria for provider participants is provided in Table 
1. Selection criteria for patient participant entry into study are listed in Table 2.  
 
Table 1.  Inclusion and exclusion criteria: Providers  
Inclusion criteria  
 
Employed by Duke PCRC clinic as 
primary care provider at least ½ FTE. 
 
Has a primary adult panel 
 
Has worked at Duke PCRC clinic for at 
least one year 
Exclusion criteria  
 none 
 
 
Table 2. Inclusion and exclusion criteria: Patients  
Inclusion criteria determined by record 
review 
 BMI ≥ 30 kg/m2 as measured at any 
clinic in previous 24 months. 
 Age 18-75. 
 Clinical appointment (well visit or 
chronic care visit) in next 4-6 weeks. 
 At least one prior appointment with the 
provider they are scheduled to see at 
target clinical appt. 
 Has a valid email address in Epic. 
Exclusion criteria determined by record 
review 
 
 None 
Inclusion criteria determined by phone  
 
English speaking 
 
BMI ≥ 29 kg/m2 by self-report (to allow 
for under-reporting) 
 
Regular email usage, defined as 
accessing email 3 or more times per 
week (on home or work computer or cell 
phone) 
Exclusion criteria determined by phone 
 In weight loss treatment program in 
past year 
 Unable to read content on websites 
without any assistance 
 
 
 
6.  Subject Recruitment & Compensation: 
Provider recruitment.  
Clinic leadership at several Duke PCRC clinics will be contacted to determine 
willingness to allow recruitment of their physicians. We will request to attend a provider 
meeting to describe the study and enroll eligible providers (see recruitment script). 
Interested providers who meet eligibility criteria (see Table 1) will be consented by PI or 
the project coordinator in a private room. Providers will be paid $100 for their time at the 
end of the study after completing the phone interview. We will recruit up to 6 providers. 
 
Patient recruitment.  

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A DEDUCE search will be used to identify potentially eligible patients. Individuals 
who appear eligible based on record review using DEDUCE (see Table 1 for criteria) will 
be emailed a recruitment letter that is signed by the patient’s primary care provider. The 
email 
from 
the 
providers 
will 
be 
sent 
using 
the 
study-specific 
email 
(wellnessprescription@duke.edu). The letter will include a number to call to opt-out. If 
individuals do not opt out within one week, we will call them to determine if they are 
eligible and interested (we have proposed one week, given that we will be recruiting by 
email and thus there is not the typical delay of a mailed letter). Participants who are 
eligible and interested will be consent by phone (see phone script). We will recruit up to 
12 patients per provider, for a total of up to 72 patient participants (with an intent of 
enrolling 60 total participants). 
Participants will be compensated $15 for completing the baseline questions (on 
phone or in-person, depending on assignment). They will be compensated $5 for 
answering the questions immediately after their medical visit, and $40 for attending the 6 
month outcome session, for a total possible compensation of $60. 
 
7.  Consent Process – This study does not involve any risks that are outside those 
encountered in everyday life, and is thus considered minimal risk. We will not be meeting 
in-person with study participants before the intervention is delivered (for half the 
participants, a baseline in-person visit will occur but will occur after the intervention is 
delivered; for the other half no in-person visit occurs until the 6 month follow-up session). 
Thus, we have requested a waiver of written consent. Participants will consent by phone. 
Approved research staff will describe the study to the participants by phone, including all 
elements required for informed consent (see phone script). Patients will be asked 
questions to ensure that they understood the study description and key elements of 
consent. They will be given option to take time to think about consent, or to consent 
immediately. After consenting (or, if they request more time to review before 
consenting), participants will be sent an email that includes a written description of all of 
the elements of consent. Additional details are provided in Section 14 of the e-IRB 
submission form and in the waiver of informed consent form.   
 
8.  Subject’s Capacity to Give Legally Effective Consent: Ability to give consent will 
be assessed in the recruitment call (for patients) and in-person meeting (for providers). 
We will not enroll participants unable to provide consent. 
 
9.  Study Interventions: All intervention and comparison condition materials are 
provided in this eIRB application. 
Intervention. The Your Wellness Prescription intervention is a single session, 
web-based intervention that involves questions and tailored motivational feedback aimed 
to help individuals decide what changes, if any, they want to make to their diet, exercise, 
or weight, and to increase their likelihood of initiating weight loss treatment. This 
intervention was created by the study PI, Megan McVay, PhD, in collaboration with her 
mentors on this project. Dr. McVay contracted a freelance web-developer to assist in 
designing the intervention. We conducted user testing on this intervention and made 
adjustments to it as part of a prior project (Pro00059364). A complete copy of the 
intervention is included in this submission. The intervention is delivered on the Duke 
licensed Qualtrics survey software. Intervention participants will be sent an email 4 to 14 
days prior to their medical appointment that contains introductory comments and a 
unique link to the intervention. The intervention includes questions about patients’ 
motivations and barriers to make changes in diet, physical activity, and weight, and their 
perceptions of weight loss treatments. Based on their responses, participants will be 

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provided tailored feedback that aims to motivate them to lose weight and join a weight 
loss program. They will be informed that they are receiving 4 months free access to a 
weight loss program as part of this study (see Weight Loss Programs section, below). At 
the end of the intervention, participants are given the option to enroll in one of three 
weight loss programs for free (see description below). They will also be given the option 
to share a summary of their results with their provider. The intervention is anticipated to 
take 15 minutes to complete. Intervention participants who do not complete the 
intervention by two days prior to their clinic visit will be sent a reminder email. 
After completing the web-based intervention, participants will be sent an email 
summary of their tailored intervention feedback. Their provider will be made aware that 
the patient completed the intervention (via EPIC messaging) and will be provided a 
summary of their tailored feedback and suggestions for discussing weight with patient (if 
patients agree) via EPIC messaging and through entry of a progress note in to their 
medical records. After their primary care visit, patients will be emailed a link again 
offering them the chance to sign up for one of the weight loss programs. 
Comparison Condition. Participants in the comparison condition will receive an 
email informing them that they have free access to the available weight loss programs. It 
will also include a link that leads to information about the available weight loss programs 
(included in submitted IRB materials) and provide information about how to sign up for 
the programs. 
Weight Loss Programs. All participants will be offered 4 months of free 
enrollment in one of three evidence-based weight loss programs: Weight Watchers, 
Jenny Craig, and Track. Weight Watchers is a commercial program that includes in-
person group educational/support sessions focused on assisting individuals in changing 
their diet to improve diet quality and achieve calorie reduction and weight loss. Session 
content also includes nutritional education as well as behavioral skills training. The 
program also encourages increased physical activity tailored to individual’s level of 
ability/skill. Jenny Craig is a commercial weight loss program that offers one-on-one 
coaching focused on dietary change to achieve weight loss, increasing physical activity 
(as appropriate to individuals ability/skills), and behavior change techniques. Jenny 
Craig also involves prepackaged foods that individuals are responsible for purchasing 
from Jenny Craig (participants are informed of this added cost as part of the Your 
Wellness Prescription Planning Tool). Track is an academically based program that was 
developed by Dr. Gary Bennett (Professor, Duke Department of Global Health) and has 
been tested in an IRB-approved clinical trial (Duke University IRB #B0033).  Track is 
completely remotely delivered and mobile phone-based. It involves setting 4 
personalized goals related to changes in diet and physical activity (e.g., no sugary 
drinks) and self-monitoring of these goals. Participants also have regular phone 
coaching sessions (weekly at first, then every other week, then monthly). Track will be 
run as a research protocol headed by Dr. Bennett (a key personal on this study) under 
this study. Additional details about Track are included in an appendix. 
Participants will enroll in each program with the following strategy.  
1. If they select Track, they will be sent an email from Your Wellness Prescription 
that asks a few screening questions and includes a consent for the study (see 
the approved Track amendment and the Track consent (Qualtrics) document). 
For participants who consent, they will be asked to provide their phone number. 
Track intervention personnel will then call patient to initiate the treatment.  
2. If they select Weight Watchers, they will be emailed a unique promo code, a link 
to a website to sign up for Weight Watchers, and instructions for how to enroll. 
3. If they select Jenny Craig, they will be emailed a letter that they will be asked to 
bring to one of two local Jenny Craig facilities (letter provided). This will assist the 

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Jenny Craig staff in recognizing that they qualify for free enrollment. Study staff 
will receive a periodic bill for services. 
 
10. Risk/Benefit Assessment: There are few potential risks associated with study 
participation. The intervention itself may result in participants feeling uncomfortable 
answering questions. However, they can discontinue the intervention at any time by 
closing their web-browser. There is the potential risk of loss of confidentiality.  However, 
we are minimizing this risk via efforts to secure data, including keeping data stored on a 
secure server accessed only by authorized study staff. The primary benefit to 
participants is free access to weight loss programs. 
 
11. Costs to the Subject: There will be no direct cost to subjects. If subjects decide to 
join a weight loss program at the end of this study, they may have to pay for the cost of 
the food they eat during the program. 
 
12. Data Analysis & Statistical Considerations: Our primary outcomes are feasibility 
and acceptability outcomes and are mostly descriptive. Our data analyses plan is as 
follows: 
1. Recruitment: Descriptive data on recruitment rate (number of eligible patients 
identified and proportion of eligible patients who consent), reasons for ineligibility, 
and reasons for declined enrollment. We will use chi-square analyses to compare 
recruitment of participants who are informed that a baseline study visit is required 
vs. participants who are no required to attend a baseline visit. 
2. Intervention use: We will present descriptive data on 1) the portion of 
participants initiating the “Your Wellness Prescription Planning Tool” intervention, 
2) portion of intervention participants completing the intervention, 3) average and 
range of page clicks on feedback report (as an indicator of engagement). This 
data will be obtained 
3. Intervention acceptability and clinical visit experience. Descriptive data on 
the acceptability questions and on questions about medical visit experience will 
be presented. 
4. Provider acceptability: Qualitative interviews with providers will be recorded 
and transcribed and analyzed using direct content analyses. 
5. Study retention. Completion rates for 6-month assessments will be presented 
for entire sample and will be presented by study condition and demographics 
(age, race/ethnicity, gender). These will be compared against the goal of 80% 
retention. 
6. Weight loss enrollment, sustained engagement, and weight change: 
Although the study is underpowered to make conclusions on weight loss 
enrollment, we will present descriptive data on treatment enrollment, sustained 
treatment use, and weight change, including presenting it by study condition. 
 
13. Data & Safety Monitoring: This is a minimal risk study so the potential for serious 
adverse events related to the study is low. The study PI (Megan McVay, PhD) will be 
responsible for monitoring participant safety during the study. Study participants will be 
asked to contact the PI to report any concerns or adverse events. Additionally, staff will 
collect information on adverse events when they are volunteered by study participants, 
and this information will be immediately reported to Dr. McVay. (Because this is a single 
session intervention with only one follow-up visit, additional proactive monitoring would 
be burdensome to participants). All serious adverse events will be reported to the IRB 
according to local IRB requirements (within 5 days of event) and will be reported to NIH 
on the progress report. A Data Monitoring Committee will be formed consisting of the 

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study PI, William Yancy, MD (primary care physician and obesity expert) and one 
additional faculty member who is independent from the study team. The team will 
convene yearly or more often as needed. The team will also look at data as the study 
progresses, including adverse events and any serious unrelated adverse events. 
 
The study PI, Megan McVay, PhD, will be leaving her position at Duke and beginning a 
position as Assistant Professor at University of Florida in January 2018. In order for her 
to oversee the study after she leaves Duke, as well as to be able to analyze the data 
from this study for purpose of publication, she is requesting a transfer of data including 
PHI to University of Florida. 
 
14. Privacy, Data Storage & Confidentiality – Paper documents that will be collected 
will be the payment form, which includes SSN, and patient assessment forms. This will 
be kept in kept in a locked filing cabinet belonging to the PI or Co-Is in room 520 in 
Legacy Tower. During the active enrollment, paper data will be temporarily kept in a 
locked cabinet in the study coordinator's office in room 9054 in Hock plaza. The key will 
be in custody of the PI or study coordinator. Only authorized study staff will have 
permission to access to paper data. 
 
Electronic data will be stored on the server \\duhsnas-
pri\dusom_psych\private\irb\mcvay\ wellness pilot and subfolders, maintained by the IT 
support staff.  
 
Research data will also be collected through REDCap database and Qualtrics. That data 
will be securely stored on a server hosted by Duke Health Technology Services (DHTS). 
 
Study tracking data (e.g., data on participants’ progress through the study, on their 
status as enrolled/completed/etc) will be stored on Duke General Internal Medicine 
Divisions’ Microsoft SQL Server running on a Windows Server maintained by DHTS. 
Access to the SQL Server data is managed via Active Directory Groups. Permissions is 
only granted to documented study personnel authorized to access the data. Access to 
the Study Tracking application is managed by Aviel Alkon who built and manages the 
Study Tracking System. 
 
DEDUCE reports used for identifying eligible patients will be saved on the study server. 
 
The subject payment forms will be stored on the psychiatry server \\duhsnas-
pri\dusom_psych\private\Exper Subject-BehMed.  
 
We will receive information about the attendance and weight information for subjects 
who joined the Weight Watchers program. Data will be obtained through Weight 
Watchers personnel providing us the data on attendance and weight that are linked to 
the promotional codes that Weight Watchers will provide us for our participants to sign 
up for the program. We will not provide any PHI to Weight Watchers. They will create an 
excel file that includes data on program attendance linked to promotional code number. 
This file will also not have PHI. They will share this data via email. 
 
 
Study staff will enter all participant information into the study web application, which is 
hosted and maintained in a remote data center (Heroku and Amazon S3). All software 
and servers are reachable only via logging in using multi-factor authentication. All 

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communication between our software’s application programming interface (API) and 
third-party software is encrypted using a protocol called Secure Sockets Layer (SSL). As 
described above, physical access to computing resources (hard drives, servers, 
networking equipment) is secure, audited, and restricted to skilled personnel; virtual 
access (login and system administration) is encrypted, audited, and limited to skilled 
personnel; all databases are encrypted and access from the public Internet is precluded; 
all software and servers are reachable only via a virtual private network (VPN) or multi-
factor authentication; and all communication between our software’s application 
programming interface (API) and third-party software is encrypted using SSL. Only 
research staff who have received CITI Certification and are listed on the Duke University 
Institutional Review Board protocol will have access to the study database. Information 
in the database will not be shared with anyone outside the research team. 
In the Track consent, we inform participants that we do collect identifying information 
and that we take all appropriate measures to minimize the risk of unintentional breach of 
confidentiality. 
 
eGRC exception was submitted (EXC-1204).