Culturally Sensitive Primary Care Clinic-based Interventions by Community Health Workers and Trained Physicians to Promote and Sustain Weight Loss Among Obese Black Women Patients
Phase: NA
Conditions: Obesity
Sponsor: University of Florida

Protocol #IRB201703386 
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NCT03418701 
University of Florida IRB-03 
Protocol  
 
Title: Culturally Sensitive, Primary Care Clinic-Based Interventions by Community 
Health Workers and Trained Physicians to Promote and Sustain Weight Loss among 
Black Women Patients with Obesity 
 
Investigators:  
Principal Investigator: Carolyn M. Tucker, PhD, Department of Psychology, College of Liberal 
Arts and Sciences, University of Florida 
Co-Principal Investigators: Nipa Shah, MD, Department of Community Health and Family 
Medicine, College of Medicine–Jacksonville 
Stephen Anton, PhD, Department of Aging and Geriatric Research, 
College of Medicine, University of Florida 
Co-Investigators: Lori Bilello, PhD, College of Medicine–Jacksonville 
 
Fern Webb. PhD, College of Medicine–Jacksonville 
 
Shiva Gautam, PhD, College of Medicine-Jacksonville  
 
Anne Mathews, PhD, IFAS, Food Science and Nutrition 
Community Co-investigator: Deloris Rentz, MS, Department of Psychology, College of Liberal 
Arts and Sciences, University of Florida 
Study Staff:  
Amy Legros, Department of Psychology, College of Liberal Arts 
and Sciences, University of Florida 
 
Frederic Desmond, PhD, Department of Psychology, College of 
Liberal Arts and Sciences, University of Florida 
Maria Bautista, MD, MPH, College of Medicine–Jacksonville 
Erica Guerrido, MPH College of Medicine–Jacksonville 
 
1. Abstract: 
Black women have the highest prevalence of obesity in the U.S. with more than half 
(56.6%) of Black women experiencing obesity. This disease increases the likelihood of 
having diabetes and other chronic diseases, and decreases quality of life and life expectancy. 
The U.S. Preventive Services Task Force recommends that all adults who have obesity 
participate in an evidence-based, intensive, multicomponent behavioral treatment for this 
disease. Such treatment has been shown to produce clinically significant weight-loss among 
patients; however, this weight-loss is typically not sustained over time. Health care 
professionals nationally agree that treatment of obesity should be occurring and evaluated in 
primary care settings.  
We will test the effectiveness of a culturally sensitive, evidence-based, multi-component, 
behavioral program for treating obesity called Health-Smart.TM This program will be 
implemented for 6 months in 20 UF Health Jacksonville primary care clinics by Community 
Health Workers (CHWs) with Black women patients who have obesity, and followed by 
either of two physician-implemented behavioral counseling weight loss maintenance 
programs that are applied quarterly over 12 months to prevent weight gain. Specifically, we 
will compare the effects on weight-loss and weight-loss maintenance of (1) Health-Smart 

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plus the Patient-Centered, Culturally Sensitive Weight Loss Maintenance Program (PCS-
WLM), and (2) Health-Smart plus the Standard Behavioral Weight Loss Maintenance 
Program (SB-WLM). We expect that (a) the PCS-WLM will result in significantly greater 
weight-loss and weight-loss maintenance compared to SB-WLM, and (b) that the model used 
to integrate CHWs into the health care team at each clinic will result in high ratings of this 
integration by the CHWs and other clinic staff involved with this study. 
 
2. Background: 
Obesity has been called a modern epidemic.1 Obesity increases the likelihood of 
experiencing various chronic diseases such as diabetes, hypertension, coronary heart disease, 
and some cancers, all of which negatively impact quality of life.2-5 Thus, reducing and 
eventually eliminating obesity continues to be a national health priority.6  
Approximately 75% of non-Hispanic Blacks are overweight or obese. This percentage is 
higher than other US racial and ethnic groups. The 2011-12 US National Health and 
Nutrition Examination Survey revealed that (a) the prevalence of obesity (BMI ≥ 30 kg/m2) 
had increased to 34.9% and (b) this obesity increase was even higher among Blacks (47.8%) 
and Hispanics (42.5%).7 Black and Hispanic women are affected by obesity more than their 
male counterparts. Notably, Black women (BW) have the highest obesity prevalence in the 
US. More than half (56.6%) of BW are obese, compared to 44.4% of Hispanic women and 
32.8% of non-Hispanic White women.7 Despite the high prevalence of obesity among BW, 
they have been underrepresented in weight-loss trials and weight-loss maintenance studies.8  
Numerous reviews have found that lifestyle interventions are effective in helping 
individuals lose weight.9 Generally, lifestyle interventions that are delivered in weekly group 
sessions over 4 to 6 months can help individuals achieve weight losses of approximately 5 to 
10% of their body weight.10 Unfortunately, many individuals who successfully lose 5% or 
more of their body weight gradually regain most, if not all, of the weight they lost.11 Thus, 
the real goal of obesity treatment should be to help individuals achieve weight loss and keep 
the weight off over the long-term.12  
Accordingly, several obesity researchers have called for a focus on preventing weight 
regain, particularly in primary care settings.7  The Obesity Reduction Black Intervention Trial 
(ORBIT) provides important insights into weight loss and maintenance for BW.10 The 6-
month weight-loss intervention in this trial was implemented by trained interventionists and 
involved twice-weekly group discussions focusing on eating a healthy diet, restricting 
calories, and increasing physical activity and related goals, plus monthly 30-minute 
motivational interviewing (MI) sessions by the interventionists.13 The 12-month weight-loss 
maintenance intervention in the ORBIT study included group sessions that decreased in 
frequency plus monthly MI sessions.8 At the end of the 6-month intervention period, the 
intervention group had lost 3.0 kg, and the control group had gained 0.2 kg. Both groups 
gained weight between months 6 and 18 (1 kg in the intervention group and 0.1 kg in the 
control group). At month 18, only 24% of the intervention group and 12% of the control 
group had lost at least 5% of their initial body weight. The authors of the article reporting 
these findings concluded that the low weight-loss and unsuccessful weight-loss maintenance 
indicates that more research is needed to identify what contributes to meaningful weight loss 
and weight-regain prevention in BW.  
 
 

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3. Specific Aims: 
The project has three primary aims. The first primary aim is to evaluate the 
effectiveness of the Community Health Worker (CHW)-implemented, clinic-located, 
evidence-based, 6-month Health-Smart weight-loss program as indicated by (1) participating 
patients’ mean weight loss and (2) percentage of participating patients who show clinically 
significant weight loss (i.e., at least 5% of baseline body weight).  
The second primary aim is to compare the outcomes of two 12-month, clinic-based 
weight-loss maintenance programs implemented by patients’ respective physicians after the 
6-month weight-loss intervention. The first program is the Patient-Centered, Culturally 
Sensitive, Weight-Loss Maintenance (PCCS-WLM) program, which is a weight-maintenance 
program implemented by physicians who receive patient-centered, cultural sensitivity 
training to enhance their ability to talk with patients about weight-loss issues in ways that 
enable patients to feel comfortable with, respected by, and trusting of their physicians. The 
second program is a standard behavioral weight-loss maintenance (SB-WLM) program that 
is recommended by the Institute of Preventive Medicine. The specific patient reported 
outcome measures related to this aim are continued weight loss or maintaining weight loss 
and changes in patients’ perceived levels of (a) satisfaction with physician care, (b) provider 
cultural sensitivity, and (c) physician engagement in discussions of their weight and health-
smart behaviors (e.g., eating and physical activity). 
The third primary aim is to implement and evaluate a Medical Assistant (MA)-led 
program designed to integrate trained CHWs into the health care team in 20 primary care 
clinics so that these CHWs can implement the 6-month Health-Smart weight-loss program 
with BW patient participants who have obesity at these clinics. MAs at each participating 
clinic will train and mentor the CHWs assigned to the clinic to become integrated into the 
heath care team at that clinic. This training will be informed by the nationally-recognized 
TeamSTEPPS Program__an evidence-based set of teamwork strategies and tools developed 
by the Agency for Healthcare Research and Quality (AHRQ) aimed at optimizing patient 
outcomes by improving communication and teamwork skills among health care 
professionals. CHW integration effectiveness will be assessed using (a) ratings by CHWs, 
MAs, and physicians in the proposed study on the relevant subscales of a TeamSTEPPS team 
integration assessment tool, the AHRQ Office Survey for Patient Safety.  
The secondary study aims are to determine if, at the end of the 12-month weight-loss 
maintenance programs, there are differences in the following participant health indicators in 
association with type of physician-implemented weight-loss maintenance program 
implemented by the participating patients’ physicians: (a) blood pressure, lipids, HbA1c, and 
blood glucose; (b) healthy eating and physical activity engagement; (c) participant-perceived 
barriers to health-smart behaviors; and (d) health-related quality of life. 
The primary hypotheses that will be tested are the following: (1) at the end of the 6-
month Health-Smart weight-loss intervention, participating patients will show weight 
reduction of at least 5% of their baseline weight, and (2) at the end of 18 months, a 
significantly larger percentage of participants at clinics assigned to the 12-month PCCS-
WLM program will maintain initial weight loss or show continued weight loss compared to 
participants at clinics assigned to the 12-month SB-WLM program. 
 
 

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4. Research Plan: 
Target Population: The target population for this study is Black women patients with 
obesity and are current patients in the UF Jacksonville Primary Care Network. This 
population was selected because they have a high incidence of mortality due to obesity, and 
have the most potential direct benefit from participating in this study.  
Inclusion/Exclusion Criteria: The participant inclusion criteria are: (1) African 
American/Black, (2) female, (3) age 21 years or older, (4) BMI of 30kg/m2 or higher; (5) 
active patient of a participating clinic (i.e., at least 2 clinic visits in the last 24 months), and 
(6) willing and ready to change one’s diet and physical activity level, and (7) willing to be 
randomized to either of the two physician-implemented weight-loss maintenance 
intervention groups. Exclusion criteria are (1) any serious medical condition that likely 
affects weight, such as end stage renal disease or cancer, (2) prior bariatric surgery within 
the last 5 years or plans for this surgery in the next 2 years, (3) use of prescription or over-
the-counter weight-loss medication within the last 6 months, (4) currently pregnant or plan 
to get pregnant within the next 2 years, (5) plan to relocate from the areas served by 
participating clinics within the next 2 years (6) having had unintentional weight loss (≥ 5% 
of body weight) within 6 months of enrollment, and (7) taking a daily dose of an oral 
corticosteroid or anti-psychotic (clozapine,  olanzapine, or risperidone) for less than six 
months. 
Participant Recruitment: Participants will be recruited from the UF Jacksonville primary 
care network. At least 20 of these primary care clinics will be targeted for recruitment of 
eligible participants, and a multi-faceted approach will be used for recruitment. At the 
participating clinics, recruitment will involve distribution of marketing materials (e.g., posters 
and flyers) in the waiting room and exam rooms. These marketing materials will include a 
telephone number to call if interested in the study. The participating provider in each clinic 
may also discuss the trial with any potentially eligible patients if they already have an 
appointment during the recruitment period. If a patient is initially interested in participating 
and appears to be eligible, the medical staff will ask the patient to complete a short form 
indicating that she would like to be contacted by a study team member to learn more about 
the trial. Additionally, to systematically identify and recruit potentially eligible participants, 
the research team will conduct an IRB-approved query of the UF Health-Jax electronic 
medical record system (Epic), and organize targeted mailings of a study participation 
invitation letter to potentially eligible patients (based on their age, race, sex and BMI). The 
letter will provide an overview of the study and the phone number to call if they are 
interested in participating in the study.  
Screening. A trained research coordinator or CHW will receive the phone calls from patients 
who are interested in participating in the trial and will perform a screening interview after 
having received verbal consent from the possible patient participant (interested caller).  See 
copy of the screening script and interview tool. If the caller meets the screening criteria and 
is interested in participating in the study, a visit with their physician or physician extender 
(ARNP or Physician Assistant) will be scheduled to ensure there are no medical 
contraindications to their participation in the study. This screening visit will include a 
review of the patient’s medication inventory, medical and hospital admission history for any 
exclusion criteria noted above as well as a physical exam that includes measuring blood 
pressure, radial pulse, and weight, administering a mini-cognitive assessment, and reviewing 

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Table 1. Delivery of the Intervention Across Clinics 
2018 
2019 
2020 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
First 
wave 
Second 
wave 
Third 
wave 
the patient’s health history. At the end of the screening visit, patients will be informed 
whether or not they qualify for the study. It is estimated that approximately 1,600 individuals 
will need to be screened in order to enroll 758 participants Participants will be enrolled in 3 
waves: Wave1 will include 7 clinics averaging 34 enrollees each, Wave 2 will have 6 clinics 
with an average of 40 enrollees each, and Wave 3 will include 7 clinics with an average of 40 
enrollees per clinic. See Table 1 for wave timing. 
 
 
 
 
 
 
 
 
 
Informed Consent. Once patients are cleared to participate in the study by their doctor, the 
CHW or research coordinator will review the informed consent form with them at the clinic, 
and the patient will be asked to give their written informed consent to participate in the 
clinical trial.  
Study Intervention. We will test the effectiveness of a culturally sensitive, evidence-based, 
multi-component, behavioral program for treating obesity called Health-Smart.TM This 
program will be implemented for 6 months in 20 UF Health Jacksonville primary care clinics 
by CHWs with Black women patients who have obesity, and followed by either of two 
physician-implemented behavioral counseling programs that are applied quarterly over 12 
months to prevent weight regain.  CHWs will be hired by the primary care network as UF OPS 
employees and trained to be staff members of the clinic to which they are assigned.  The 
CHWs will also receive extensive training on the Health-Smart program by the PI (Dr. Tucker) 
and her team prior to program implementation.  A brief description of each intervention 
component used in this study is as follows: 
Measurement Session 1.  The patient’s baseline biometric data (weight, height, blood 
pressure) will be measured by an MA at their physician’s clinic. Additionally, blood will be 
drawn to assess total cholesterol, LDL- cholesterol, HDL-cholesterol, triglycerides, glucose, 
and HbA1c if this has not been done in the last 30 days or during the physician screening 
visit. These data will be entered into the Health Data Log. Every attempt will be made to 
obtain the blood sample while the patient has been fasting. However, when that is not 
feasible, it will be noted in the form that the patient has not been fasting. Next, a trained 
CHW at the patient’s primary care clinic will provide a battery of questionnaires to be filled 
out on site (see Questionnaire/Instruments section for descriptions).  The research 
coordinators assigned to the clinics for this project will input the patients’ biometric and lab 
data from the Health Data Log form and store it in the dedicated IRB research drive to 
prepare the data for analyses. Patient name, the date the measurement was taken, and the 
name of the clinic they are assigned to will also be included in the database. 
      Participation in the 6-month Health-Smart weight loss program. Within two months 
after completing Measurement Session 1, patients will begin the Health-Smart weight loss 
program.  The 6-month clinic-adapted Health-Smart intervention is part of both 
comparators and includes the following components/strategies: (a) assessment of each 

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participant’s motivators of and barriers to health-smart behaviors using the Motivators of and 
Barriers to Health-Smart Behaviors Inventory14—which has been published by the study PI; 
(b) coaching by a trained CHW that involves using the inventory-identified motivators and 
barriers to facilitate the patient participant’s goal-setting and identification of strategies to 
achieve their goals, teaching participants to monitor selected health-smart goals and related 
goal attainment strategies, reviewing the standard goals for all patients that include 5% 
weight loss and increasing or maintaining steps walked to meet the 10,000 steps per day 
walking goal, and facilitating a patient-family member/friend discussion during which the 
patient asks the family member/friend to engage in behaviors that will support the patient in 
implementing her health-smart goal achievement strategies; (c) three months of weekly group 
sessions and then 3 months of bi-weekly group sessions; (d) 150 minutes of physical activity 
each week via patient participant-arranged or CHW-arranged activities such as group walks 
and individual walking to achieve 10,000 steps per day, and/or other self-selected moderate 
physical activities, and documentation of the physical activities in addition to documenting 
steps walked. Furthermore, the walking steps should begin with any number of steps that can 
be walked without any physical discomfort (e.g., pain, difficulty breathing) and then 
gradually increased by a number of steps that can be walked without any physical 
discomfort. Additionally, for participants who cannot walk at all, the physical activity goal is 
to engage in any physical activity up to 150 minutes per week that does not cause any 
physical discomfort. During at least one of the sessions in the Health-Smart intervention, 
patient participants will be given the opportunity to anonymously or directly ask health-
related questions to a panel of health experts (e.g., dietitians) and Black women community 
members who have lost weight and maintained this weight loss. 
The first week of Health-Smart will involve having a trained CHW, employed by the 
clinic, to help participating patients set health-smart behavior goals and weight-loss goals and 
identify strategies for achieving these goals using the Motivators of and Barriers to Health-
Smart Behaviors Inventory (MB-HSBI). The CHW will review the standard goals for all 
patients that include 5% weight loss and increasing or maintaining steps walked to meet the 
10,000 steps per day walking goal. Patients are will be asked to bring a family member or 
friend support person to the first session of Health-Smart only. This support person will be 
asked to make a commitment to help achieve the patient’s health-smart goals.  
Patients will attend the CHW-led Health-Smart weekly 1 ½- to 2-hour group sessions for 
3 months and then bi-weekly group sessions for another 3 months.  During these sessions, 
patients will be weighed. Patients will view and discuss segments of a Health-Smart DVD 
that show culturally diverse families and community members, licensed physicians and other 
health care providers discussing health-smart behaviors and “real world” strategies for 
promoting these behaviors. Patients will be given a Health-Smart Resource Guide that is a 
supplement to the Health-Smart DVD—a guide that contains more detailed information 
about the discussed health-smart behaviors and “real world” strategies for promoting these 
behaviors. Patients will be encouraged to review sections of the Health-Smart Resource 
Guide that are relevant to each week’s group discussion. Patients will also be encouraged to 
follow a reduced-calorie eating plan to promote a 5% loss of their current body weight during 
the 6-month weight-loss intervention. Sample reduced-calorie meal plans that provide 
approximately 1200 kcals from a well-balanced diet from a variety of foods emphasized in 
the 2015 Dietary Guidelines for Americans will be provided to patients. They will also 
participate in 150 minutes of physical activity each week - either on their own or arranged by 

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a trained Community Health Worker. Throughout the 6-month Health-Smart program, 
patients will be using a Food and Activity Diary to record their steps walked using a 
pedometer that will be provided to them as well as document other physical activity 
performed during each week. They will also be recording food and beverages consumed 
daily.  
Measurement Session 2. After the completion of the 6-month Health-Smart weight loss 
program, patients’ weight, height, blood pressure will be measured by a Medical Assistant at 
their physician’s clinic. Additionally, patients’ blood will be drawn to assess their total 
cholesterol, LDL- cholesterol, HDL-cholesterol, triglycerides, glucose, and HbA1c and they 
will complete the questionnaires previously completed as part of Measurement Session 1. 
The research coordinators assigned to clinics will input the patients’ biometric and lab data 
from the Health Data Log form and store it in the dedicated IRB research drive. 
Weight Loss Maintenance Support from Primary Care Physician. During the 12 
months after completing the 6-month Health-Smart weight loss program, patients will 
have quarterly visits with their physician (at no charge to the patients) so that the 
physician can provide counseling and support to the patients that is designed to help the 
patients continue to lose weight or maintain the weight loss that resulted from 
participating in the Health-Smart weight loss program. In this phase, two different 12-
month weight maintenance programs implemented by physicians will be compared 
(PCCS-WLM program and SB-WLM program). Both the patient and the CHW will be 
blinded on which program the patient will be participating in. The clinics will be 
randomly assigned to one of these two programs. The PCCS-WLM program (Comparator 
1) will be implemented by the physicians of the participating patients at 10 clinics in this 
study, and the SB-WLM (Comparator 2) will be implemented by the physicians of 
participating patients at a separate set of 10 clinics in the study.  Both of these programs 
consist of patient-physician clinical encounters every three months over a 12-month 
period, during which physicians in each program will review each of their participating 
patient’s clinic-tracked weight/BMI and implement evidence-based provider behavioral 
counseling strategies for weight-regain prevention with each of these patients. A 
summary form that includes the patient’s weight loss goals and health-smart goals will be 
provided to the physician prior to their first maintenance visit. 
Focus Groups. Focus groups with Black women with weight concerns will be performed 
to identify specific ways providers can demonstrate cultural sensitivity that will be among the 
foci of the physician training for the PCCS-WLM program (Comparator 1). A minimum of 
two but no more than four focus groups will be conducted before the end of 2018. Each 
group will include 6 to 10 participants per focus group.  Each participant will receive a $30 
gift card for their participation and will be required to complete a gift card receipt form that 
includes their name, social security number, address, and phone number. Focus group 
participants will be recruited from the general population through disseminating flyers about 
these groups at local clinical settings (e.g., the participating clinics and at hospitals and walk-
in health care sites), community settings (e.g., local Black churches), and meetings that are 
attended by large numbers of Black women. The snowball technique will also be used to 
recruit Black women to participate in the focus groups. This technique involves having 
individuals who to agree to be research (focus group) participants help recruit other focus 
group participants. Focus groups will be held at UF Health, or at an identified site closest to 
the participating women.  

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A focus group guide has been created to standardize what information will be collected 
during each session. Black women group facilitators for each focus group will follow the 
guide, which includes a standard introduction and focus group questions. These group 
facilitators will have had experience in conducting focus groups and will be trained in 
conducting the focus groups for this study. Each focus group discussion will be audio-
recorded with notes taken on key issues by graduate students supervised by the one of the 
members of the research team. The audio-recordings will be transcribed and analyzed as 
described in the focus group guide. Information from the focus groups will help inform the 
physician training curriculum for the physicians in the PCCS-WLM program (Comparator 1). 
The audio-recordings of the focus groups will be destroyed 5 years after these recordings are 
made and will be stored in a locked file cabinet in the Psychology Building at the University 
of Florida’s Gainesville campus until they are destroyed. The PI, Co-PIs, Co-Is and other 
study staff as well as a hired transcription company will have access to the audio recordings 
for transcription purposes only. After the transcriptions are made, the PI, Co-PIs, Co-Is and 
other staff will have access to the audio-recordings until they are destroyed. The audio-
recordings will be destroyed by Shred-it—a UF authorized Destruction and Disposal 
Services Company.  
Physician Training for Implementing the Weight Loss Maintenance Programs. Prior 
to beginning either of the physician-implemented weight-loss maintenance programs, the 
physicians who deliver each program will receive training on how to implement the 
program that will be provided in their respective clinic. The physician training time for 
implementing the PCCS-WLM program (Comparator 1) will be the same as the physician 
training time for implementing the SB-WLM program (Comparator 2). All of the 
physicians, regardless of which program they implement at their clinic, will experience 
the following in this order: (a) completion of the Tucker Culturally Sensitive Health Care 
Inventory – Provider Version, (b) 4-hour training that will include a 3-hour in-person 
training and a 1-hour on-line training, ( c) 3 booster training sessions (in person and 
online), scheduled to occur at quarterly intervals (i.e., just prior to each quarterly 
physician-patient weight loss maintenance program visit), and (d) completion of the Tucker 
Culturally Sensitive Health Care Inventory – Provider Version at the end of the study. We 
will also implement a satisfaction survey for the physicians regarding the weight loss 
maintenance phase (i.e., at month 18). Dr. Tucker will lead the training for the physicians 
who will implement the PCCS-WLM program (Comparator 1), and Dr. Anton will lead 
the training for the physicians who will implement the SB-WLM (Comparator 2). In all of 
these trainings, the physician trainees will be instructed to remind their patient 
participants of the importance of reaching and/or maintaining the health-smart goal of 
reducing their body weight at least 5% from when they began the earlier 6-month Health-
Smart program.  
Description of the PCCS-WLM program (Comparator 1). This program is designed 
to enable physicians to: (a) talk with their Black women patients about their weight, 
weight loss goals and goal barriers, and strategies for overcoming their goal barriers, and 
deliver this talk in patient-centered, culturally sensitive ways (i.e., in ways that enable 
Black women patients to feel comfortable with, trusting of, and respected by the 
physicians talking with them), (b) assist their patients with engaging in self-identified 
strategies for achieving and sustaining their self-selected health-smart goals for weight 
loss and overall health, (c) be knowledgeable about health-smart behaviors (healthy eating 

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and drinking, physical activity, and managing stress/anxiety, and depression), (d) use 
behaviors and display attitudes in physician-patient interactions with Black women 
patients that are provider cultural sensitivity indicators in published literature 15,16,17 , but 
customized for use when counseling Black women patients with obesity—customized 
based on operationalization of these indicators by the Black focus group participants who 
were asked to identify specific ways to show these indicators when talking with Black 
women with obesity about their weight and weight loss, and (e) say and display behaviors 
and attitudes that Black women in the aforementioned focus groups identified as 
important when discussing obesity and losing weight with Black women patients who 
have obesity.  
Description of the SB-WLM program (Comparator 2). This program is designed to 
enable physicians to: (a) implement motivational interviewing approaches when talking 
with their patients about their weight loss goals and behavioral strategies to achieve these 
goals, (b) become knowledgeable about empirically supported behavioral change principles 
that have been used to help patients maintain weight loss in previous interventions, (c) 
communicate how to use these empirically supported behavioral change principles to have 
patients initiate or maintain their self-selected health-smart goals related to weight loss 
and/or weight loss maintenance, and (d) use motivational interviewing approaches to 
communicate empathy and understanding with patients who are struggling to maintain their 
weight loss and/or accomplish a behavioral goal.  
  External Control Monitoring to Verify that the Physicians and CHWs are 
Following Provided Training.  This external control monitoring will occur during the 
CHW integration period, the CHW implementation of Health-Smart, and the physician 
weight loss maintenance year. The CHW monitoring will be conducted by undergraduate 
student researchers in a research lab course taught by the PI and from among the study 
staff—all of whom will be trained to conduct this monitoring. This external control 
monitoring will involve observing health-smart group sessions, either in person or through 
teleconferencing, that are run by CHWs and using a monitoring form to rate whether or not 
the activities of the sessions were implemented by the CHWs. The study staff, either in 
person or through the telemedicine system, will observe the physicians to monitor fidelity 
to the weight maintenance program that they were trained to implement. 
Measurement Session 3. After the completion of the quarterly physician visits, patients 
will have their weight, height, blood pressure, blood glucose, Hemoglobin A1c, and lipids 
measured again as well as complete the questionnaires previously completed at Measurement 
Sessions 1 and 2. The research coordinators assigned to clinics will input the patients’ 
biometric and lab data from Health Data Log form and store it in the Dedicated Research 
Drive. 
Participant Questionnaires/Instruments. The following tools will be administered 
during the measurement sessions.  Most of these questionnaires will be completed at each 
measurement period except the following that will only be administered at the 2 and 3rd 
measurement period:  Health-Smart Participant Satisfaction Questionnaire, Patient Survey of 
Provider Weight Management Practices, Patient Satisfaction Questionnaire – 18, and Tucker 
Culturally Sensitive Health Care Inventory – Patient Version.  The questionnaires will be 
filled out electronically on a computer or tablet using Qualtrics and stored in a secure UF 
server. The survey data will include a patient identification number for tracking purposes.  
No PHI or medical records including lab results will be stored in Qualtrics, only patient 

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satisfaction and perceptions information. A CHW will be present when each patient is 
completing the questionnaires and will provide each patient with whatever assistance is 
needed when completing the questionnaires.  A paper version will be available for those who 
cannot complete it online. 
 
 Motivators of and Barriers to Health-Smart Behaviors Inventory (MB-HSBI)–Adult Version 
(Tucker, Rice, Hou, Kaye, Nolan, Grandoit, Gonzales, Smith, & Desmond, 2011). The MB-
HSBI—Adult Version is a 129-item inventory that assesses motivators of and barriers to 
engaging in specific health-smart (health promoting) behaviors within each of the following 
four domains: (1) Eating a Healthy Breakfast, (2) Eating Healthy Foods and Snacks, 
(3) Drinking Water and Other Healthy Drinks, and (4) Engaging in Physical Activity. For 
each of these four domains, the MB-HSBI includes a “Motivators” section that assesses 
what motivates respondents to engage in the identified health promoting behaviors and a 
“Barriers” section that assesses barriers to engaging in the identified health promoting 
behaviors. 
International Physical Activity Questionnaire (IPAQ). IPAQ is a 27-item self-report 
questionnaire that assesses physical activity in five activity domains (job-related, 
transportation, housework/house maintenance/caring for family, recreation/sport/leisure 
time, and time spent sitting).21  
Dietary Short Questionnaire (DSQ, NCI/NHIS CCS 2010 version). The DSQ is a 27-
item survey that asks about the frequency of consumption of selected foods and drinks in 
the past month.22 
Weight Control Strategies Scale (WCSS). The WCSS is a self-report measure to assess the 
use of specific strategies for losing weight or maintaining weight loss. The 30-item WCSS 
contains four subscales: Dietary Choices, Self-Monitoring Strategies, Physical Activity, and 
Psychological Coping.23 
USDA Adult Food Security Survey Module (AFSSM). The AFSSM addresses conditions 
and behaviors related to one’s experience of, and anxiety due to, limited instances and 
consequences of reduced food intake. 24 
World Health Organization (WHO) Quality of Life–Brief Form (WHOQOL-BREF). This 
26-item survey assesses self-reported quality of life, defined by the WHO as “an 
individual’s perception of their position in life in the context of the culture and value 
systems in which they live, and in relation to their goals, expectations, standards and 
concerns.” The questionnaire consists of an overall quality of life question, an overall 
health question, and questions that assess four quality of life domains (physical health, 
psychological health, social relationships, and environment); however, only the physical 
health (7 items) and psychological health (6 items) domain items will be used in this 
study.25 
Demographic and Health Information Questionnaire. This researcher-constructed questionnaire 
is designed to obtain patients’ basic demographic and health information (e.g., age, gender, 
race/ethnicity, annual household income, highest level of education completed, marital status, 
employment status, and weight- and obesity-related information and diseases). 
Health-Smart Program Evaluation Questionnaire - Participant (6 month and 18 month) – This 
researcher constructed questionnaire is designed to measure the participants’ satisfaction with 
the Health-Smart Program.  These will be administered at Measurement 2 and 3 time periods. 

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General Satisfaction subscale of the Patient Satisfaction Questionnaire-(PSQ-18). This 
subscale assesses patients’ level of agreement that they view their medical care broadly as 
perfect and level of agreement that they are dissatisfied with some aspects of their medical 
care. Items from this questionnaire that will be included in the present study are items 1, 2, 
4, 6, 13, and 14.18 
Tucker-Culturally Sensitive Health Care Provider Inventory-Patient Form (T-CSHCPI-PF). 
The T-CSHCPI-PF is a 27-item inventory that will be used to assess patient 
participants’ perceived level of provider patient-centered cultural sensitivity. This inventory 
is comprised of three sub-scales: (1) Competence/Confidence, (2) Sensitivity/Interpersonal 
Skill, and (3) Respect/Communication.19  
Patient Survey of Provider Weight Management Practices. This is an 18-item survey 
developed by the Oregon Rural Practice-based Research Network and the Oregon Health & 
Science University in collaboration with the Agency for Healthcare Research and Quality. 
Two items from the 18-item Patient Survey of Provider Weight Management Practices (items 
8 and 13) will be used to measure participants’ perceived levels of their physician’s 
engagement in discussions of their weight and health behaviors.20 
 
Table 2 lists the measures that will be completed at each Measurement Session.  
Table 2. Schedule of Patient Participant Assessments 
 
Intervention-Phase Month 
Category 
 
0 
6 
18 
Informed Consent and Eligibility criteria 
X 
 
 
 
Body weight (Primary outcome) 
X 
X 
X 
X 
Patient Goals setting 
 
X 
 
 
Physiological Measures 
 
X 
X 
X 
Lifestyle Change Behaviors 
 
X 
X 
X 
Psychological Measures 
 
X 
X 
X 
Measures of patient participants’ 
satisfaction with Health-Smart 
 
 
X 
X 
 
CHW Integration. To address the third primary aim, we will implement and evaluate 
the medical assistant led (MA-led) program designed to integrate the CHWs into the health 
care team so that these CHWs can implement the 6-month Health-Smart weight-loss program 
at these clinics. The Office Manager and MAs at each participating clinic will train and 
mentor the CHWs assigned to that clinic to become integrated into the heath care team at that 
clinic. This training will be informed by the nationally recognized TeamSTEPPS 
Program26__an evidence-based set of teamwork strategies and tools developed by the Agency 
for Healthcare Research and Quality and aimed at optimizing patient outcomes by improving 
communication and teamwork skills among health care professionals. CHW integration 
effectiveness will be assessed using ratings by CHWs, MAs, and physicians on the 
TeamSTEPPS Medical Office Survey of Patient Safety. In particular, two subscales from 
this survey (the Working in Your Medical Office subscale, and the Communication and 
Follow-up subscale) will be administered electronically using Qualtrics at the beginning of 
the project prior to TeamSTEPPS training and after the 6-month Health-Smart weight-loss 
program.  The survey will be anonymous and no personal health information is collected. 

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Compensation.  Participating patients can receive up to $150 in gift cards by participating in 
each of the three Measurement Sessions. Specifically, they will receive a $25 gift card after 
participating in the first Measurement Session (Baseline), a $50 gift card six months later 
after participating in Health-Smart and the second Measurement Session (Month-6), and a 
$75 gift card 12 months later after participating in the weight loss maintenance sessions with 
their physician and the third Measurement Session (Month-18).  
Participant Safety.  The data taken during the measurement sessions will also be used for 
safety measures. If a BP measurement is taken that is an alert value, as listed in the Table 3 
below, repeat measurements will be taken per clinic protocol.  An average of at least two 
measurements will be used to determine the appropriate plan of action. The machine that 
measures blood pressure often also provides a pulse rate reading. The patient’s pulse rate is 
not an outcome measure in the study, but will be addressed if it is outside of the normal 
range. Total cholesterol, LDL- cholesterol, HDL-cholesterol, triglycerides, and HbA1c will 
be assessed through point of care (POC) testing, as specified in the Study Intervention 
section above.  Based on the readings of these measurements, an appropriate plan of action 
will be taken. Table 3 below lists both Urgent (notify PCP within 24 hours) and Alert values 
(notify PCP immediately while patient is still in the office). If the patient has a result in the 
alert value range, the physician or non-physician provider will determine if 911 needs to be 
called. 
Table 3. Safety Assessments and Action Needed During Health-Smart Intervention 
Sessions.  
 
Normal 
Not Clinically 
Significant 
(Document as per 
study protocol) 
Urgent (Notify 
PCP in <24 h) 
Alert (Notify PCP 
Immediately) 
Systolic BP (mm 
Hg) 
90-130 
130-160 
Low: 80-90 w/o 
Sx* 
Low: <90 w/ Sx or 
<80 
High: >190 
High: 160-180 
Diastolic BP 
(mm Hg) 
70-90 
60-94 
Low: 50-60 w/o 
Sx 
High: 95-110 
Low: <60 w/ Sx or 
<50 
High:  >110 
LDL-c (mg/dl) 
<100 
100-190 
>190 
NA 
Triglycerides 
(mg/dl) 
<150 
150-400 
400-800 
>800 
Glucose 
(mg/dl) 
80-125 
70-140 
Low: 60-70 
High:141-300 
Low: <60 
High: >300 
Pulse 
60-100 
60-100 
Low: < 59 w/o Sx 
High: >100 w/o 
Sx 
Low: < 59 with Sx 
High: >100 with Sx 
*Sx = symptoms of low blood pressure or pulse such as light headedness, dizziness, syncope 
(fainting) near syncope, palpitations, headache, vision changes, chest pain, shortness of breath. 
If the patient experiences a serious adverse event at any of the Health-Smart intervention 
sessions that occur outside the clinic or after clinic hours, the CHW will call 911 and 

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complete a Serious Adverse Event Form that will be sent to the patient’s health care provider 
and to the PI. 
Participant Privacy and Confidentiality. The following steps will be taken to protect 
participants’ privacy and confidentiality:  
• Prior to recruiting patients for this study, CHWs will complete the required HIPAA and 
CITI or NIH GCP trainings as required by the IRB as well as training on how to enroll 
participants and implement all aspects of the study intervention.  
• All signed consent forms will be kept in a locked file cabinet in a locked office at the 
study team’s office in Jacksonville (Tower II, Suite 6015). 
• All electronic documents and data will be stored in secure, password-protected servers 
on the UF campus.  
• All paper based study documents including patient surveys and data collection forms 
will be stored in a locked filing cabinet in a locked room in the Center for Health Equity 
and Quality Research office on UF Health Jax campus. 
 
5. Statistical Analysis 
The primary outcome is change in body weight (weight loss and maintenance of weight loss) 
in BW patient participants at the 20 participating primary care clinics. The unit of 
randomization will be the primary care clinic. Each clinic will be randomized into one of the 
two weight loss maintenance conditions (PCCS-WLM and SB-WLM). 
Sample Size/Power. To detect a weight-loss difference of 5 pounds (between two groups) 
with a standard deviation of 12.5 pounds with 80% power and a 5% significance level, we 
will include 20 clinics and 25 study participants per clinic. Based on our pilot data, an intra-
class correlation of 0.05 among patients within a clinic is used in these calculations. Based on 
the power calculation above, a total of 500 participants (20 clinics x 25 patient participants 
per clinic) will be needed for final analyses. Assuming a 25% dropout rate of patients per 
clinic, we will need 34 patients per clinic; thus, 680 patients will be enrolled in the study. 
However, based on Wave 1 (which involves 7 clinics) patient participant drop-out rate, the 
number of participants per clinic will need to be increased for Wave 2 and 3 to an average of 
40 patients per clinic. Thus, the maximum number of patient participants enrolled in the 
study will be 758. Consequently, each of the two study arms will have a maximum of 379 
patient participants. 
Data Analysis. Shiva Gautam, PhD who has a doctorate in Biostatistics will perform data 
analysis. Analyses begin with numerical and visual summaries of baseline characteristics of 
the sample. Continuous variables will be summarized by means, standard deviations, and 
medians. Categorical variables will be summarized by frequencies and percentages. Visual 
summary may include graphs, charts and tables. The main outcome variable (weight change) 
will be analyzed using a 2-level hierarchical model within the framework of a linear mixed 
model. The 2 levels of hierarchy will be defined as patient-level and clinic-level. Data will be 
analyzed within the context of linear mixed model. Weight loss between 6 and 18 months 
will be evaluated and compared between groups by defining an appropriate contrast within 
the model. Similarly, weight loss from baseline to 6 months also will be estimated (but not 
compared) by defining a contrast. It is assumed that those participants with BMIs greater 
than 50 will lose weight at the same rate of those with BMIs between 30 and 50.  However, 
we plan to analyze the weight loss rates in two ways: one with all of the participants in the 
analysis and another with BMIs greater than 50 excluded. Based on these two analyses, we 

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can see if the subset of participants with BMIs greater than 50 impacts the effect size. These 
data sets will be compared using a mixed model for categorical data (e.g., GLIMMIX 
procedure in SAS). Descriptive analysis will be used to evaluate the effect of age, BMI, 
poverty rate (according to zip code), insurance type, and HbA1c at baseline. 
 
6. Data Safety and Monitoring Plan 
The Principal Investigator and Co-Principal Investigators with the advice and assistance 
of the Advisory Board will monitor all aspects of the safety of the study intervention and 
assessment procedures. In addition to this ongoing monitoring by the study team, a Data and 
Safety Monitoring Board (DSMB) will be established to ensure the safety of all participants 
involved in the study and the validity and integrity of the data. The DSMB and its chair will 
be named and approved by the Advisory Board and ultimately PCORI. It is planned that the 
DSMB meets by conference call on a bi-annual basis.  
The DSMB has access to all study data, documents and progress. The DSMB has the 
following charges: 
• Review the study protocol. 
• Review data (including masked data) over the course of the trial. 
• Identify problems relating to safety over the course of the study. 
• Identify needs for additional data relevant to safety issues and request these data from 
the study investigators. 
• Propose appropriate analyses and periodically review developing data on safety and 
endpoints. 
• Make recommendations regarding recruitment, treatment effects, retention, 
compliance, safety issues and continuation of the study. 
• At any time, the DSMB may recommend discontinuation of any component/treatment 
group of the study. However, the IRB will decide whether or not to accept any 
recommendation from the DSMB to discontinue a component or components of the 
study.   
Any serious adverse event that might be due to the study intervention will be reported to 
the patient’s health care provider, the PI, the DSMB and the IRB.  
 
7. Possible Discomforts and Risks 
 
There may be possible discomforts or risks in obtaining a blood sample for the diagnostic 
lab tests. These possible discomforts or risks include discomfort at the site of puncture; 
possible bruising and swelling around the puncture site; an infection; and faintness from the 
procedure. The blood sample will be obtained at the participant’s primary care clinic, and 
clinic staff are trained to handle any adverse event from the procedure. 
 
Another possible risk is lack of privacy or confidentiality of PHI. A number of methods 
are employed to maintain confidentiality of participants.  First, questionnaire data are 
collected in secure spaces where the interview cannot be overheard.  Secondly, only study 
investigators and key research staff have access to the study database.  Individual names will 
ultimately be removed from the study database, and consequently, only a unique study 
identifier will be used to distinguish participants in the database.  Fourth, collected data are 
maintained in locked computer files and file cabinets to which only study investigators have 
access.  Collected data will be used only for research purposes.  Published data will not 
contain any individual identifiers. 

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Another possible risk is increased anxiety due to wanting to lose weight and not being 
able to lose as quickly as one would like. Another possible, but less likely risk, is weight 
gain. The CHWs and physicians who implement parts of the tested interventions will be 
trained to be supportive of patient participants’ program participation regardless of their 
weight loss.  
There will be no financial risk to the participant.  All study related expenses, including 
physician visits and diagnostic lab tests, will be covered by the study sponsor. 
 
8. Possible Benefits 
 
Participants may personally benefit from taking part in this study since they will learn 
strategies to eat healthier, exercise more, get more rest, and manage stress and depression. 
They also may lose weight, which, for people with obesity, is often associated with 
improvements in health.   
 
The information obtained in this study will help determine the effectiveness of Health-
Smart and the physician-implemented weight loss maintenance programs for promoting 
and/or maintaining weight loss among Black women patients. If these interventions are found 
to be effective, they can be implemented at other primary care clinics with other Black 
women patients. Support would also be provided for testing these interventions with other 
women at primary care clinics who are not Black.  
 
9. Conflict of Interest 
There is no potential conflict of interest.  

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