A Watermelon Focused Dietary Inflammatory Index Counseling System to Reduce Systemic Inflammation
Phase: NA
Conditions: Inflammation, Diet Modification
Sponsor: Michael D. Wirth

 
 
 
 
Watermelon Focused Dietary Inflammatory Index Intervention 
 
Clinical Trials Registration: NCT03158740 
04/2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PIs of Watermelon Board funding awarded to Connecting Health Innovations: Michael D. Wirth and Nitin 
Shivappa 
 
IRB Protocol  
April, 2017 
 
In addition to the information provided in this protocol, the original research proposal will be included 
with the IRB application.  The focus of this IRB application is on intervention participants. 
 
Project Summary:  
 
Chronic inflammation underpins the development of numerous chronic diseases that contribute significantly to 
disability and mortality in the United States (US).1,2 Of particular interest, as it relates to inflammation, is diet 
which is a strong moderator of systemic inflammation.3,4 Diets high in fruit and vegetable intake, fish, and 
whole grains (e.g., Mediterranean and vegetarian diets) have been associated with lower levels of 
inflammation.5,6 On the other hand, diets rich in red meat, high-fat dairy products, and refined grains (Western 
diet) are typically associated with higher levels of inflammation.7,8 Up until 2014, no dietary index has been 
designed specifically to determine the inflammatory potential of individual’s diet. However, researchers in the 
Cancer Prevention and Control Program, University of South Carolina developed the Dietary Inflammatory 
IndexTM (DII).9 The DII quantifies the level of dietary inflammatory potential on a scale from maximally anti- to 
pro-inflammatory. Watermelon is one of the fruits whose components have been shown to have anti-
inflammatory effects.10 The overall objective of this proposal is to determine if a refined and modified 
watermelon-focused DII counselling system can reduce levels of chronic inflammation. The DII is a validated 
measure that has been shown to predict a range of outcomes including inflammation, cancer, CVD, and 
mortality, among others.11-19  
Specifically, the aims of this proposal are to:  
1. Refine and modify the DII-based intervention by developing and incorporating numerous watermelon 
recipes which will score low (anti-inflammatory) on the DII scale.  
2. Design and implement a two-arm intervention trial based on the refined watermelon-focused DII-based 
program for reducing levels of chronic inflammation. Each arm will have 15 participants (plus an 
additional 15 partners recruited by the intervention-arm participants).  The intervention arm will receive 
the modified DII intervention whereas the control arm will receive general health education. 
Target Population and Intervention Participants 
 
This non-randomized, two-arm trial will enroll and complete measurements on 30 individuals (n=30 control and 
n=30 intervention). Participants will be recruited from the broader Columbia, SC community, including African-
American churches which we have worked with on several research studies conducted through the University 
of South Carolina to date. We will recruit participants from the community via fliers and listserv messages. The 
trial will be based at the main offices of the University of South Carolina’s Cancer Prevention and Control 
Program in Columbia.  Potential participants will be provided with a study information sheet which outlines 
inclusion and exclusion criteria (see below) and provides details about the study. If the individual is interested 
in participating, then they will complete a study contact sheet, which will be given to study staff at Connecting 
Health Innovations (CHI). Given we will be recruiting from African-American churches, as well as the general 
community, we expect to enroll mainly African Americans. However, recruitment will not be restricted on race 
or ethnicity.  
 
Inclusion Criteria: 
• 
Be ≥18 years of age 
• 
Have no serious, unstable co-morbidity that would make participation in a diet and PA intervention 
difficult or risky 
• 
Be willing and able to participate fully in the study for a period of three months 
• 
Have Columbia, SC area residence and be able to travel to and from the clinic and intervention sites 
• 
Have access to the Internet and a valid email address 
• 
Not be currently enrolled in a weight loss study or actively taking weight loss medications.  
• 
Have a body mass index (BMI, kg/m2) between 25.0-49.9. 

  
Exclusion Criteria: 
• 
Serious, unstable co-morbidity that would make participation in a diet and physical activity intervention 
difficult or risky including renal disease retinopathy, peripheral vascular disease or neuropathy; 
• 
Any medications that are known to influence CRP levels such as chronic steroid (e.g., prednisone) use; 
• 
Diagnoses of congestive heart failure, chronic renal failure, chronic liver disease (including alcoholic 
cirrhosis), cancer within the past year (except for non-melanoma skin cancer); 
• 
Actively receiving cancer treatment; 
• 
Have had any major surgeries in the past 3 months; 
• 
Poor performance status according to the World Health Organization definitions (i.e., Level 3: 
symptomatic, >50% in bed, capable of only limited self-care; or Level 4: bedbound); or 
• 
Life expectancy <3 years, on hospice, nursing home or other institutionalized care. 
 
Recent attention to behavioral interventions has pointed out limitations in traditional randomization schemes 
among these types of randomized controlled trials (e.g., inability to truly blind participants, lack of decision 
making by participants).20 Other methods of allocation, which take into account perceived ability to comply with 
intervention requirements, are much more appropriate for this kind of intervention. Therefore, we propose that 
only individuals who are motivated to make a healthy diet change will receive the intervention. 
 
Recruitment and Consent Procedures  
Fliers will be distributed at a couple of African-American churches which have participated in previous Cancer 
Prevention and Control Program (CPCP) studies, as well as general community locations, including but not 
limited to USC. Additionally, recruitment efforts will utilize target listserv messages. Once a potential participant 
is identified, he or she will be provided with a study information sheet which outlines inclusion and exclusion 
criteria (see below) and provides details about the study. If the patient is interested in participating, then they 
will complete a study contact sheet, which will be given to researchers at CHI. After an individual has been 
identified and completed a contact form, CHI staff will contact the patient and conduct a brief phone screener 
with them. If the individual qualifies, they will be asked to schedule a group orientation meeting time that is 
convenient for them. Numerous studies, including those conducted by this study’s staff, have indicated greater 
commitment and motivation to participate in health behavior interventions when undergoing that intervention 
with a family member or close friend. Therefore, intervention participants will be asked to invite one person to 
the intervention classes.  
 
At this group orientation, participants will learn more about the study and what will be involved. They will be 
given consent forms to complete. Once consented, they will be instructed on completing the baseline 
questionnaires and the 24-hour Dietary Recall (ASA24™). Participants also will be instructed on using the 
Actigraph GT3X-BT for 7 days (more detail is under Participant Expectations) to measure physical activity and 
sleep. After this meeting, participants will have two weeks before the start of the study. During that time, they 
will complete the 7 days of wearing the Actigraph and will complete four days of dietary reporting using the 24-
hour Dietary Recall (ASA24™).21 In addition, the participant will visit the CPCP where they will have their 
height and weight and blood pressure assessed, and laboratory blood work done (more detail is under 
Participant Expectations). Once visits are completed and at least 7 days have passed, the study coordinator 
will collect the Actigraph from the participants. Participants selected as controls will complete all of the same 
measures the primary participants will do but will not receive the intervention and will not need to attend the 
orientation session.  
 
After all baseline measures are completed, participants will start the weekly group sessions. After at least one 
class has been completed, the study nutritionist will provide participants with an individualized counseling 
session to provide individualized guidance on study-related dietary and exercise requirements. 
 
Participation Expectations (Intervention) 
One groups of 15 individuals, plus their invited partners, will meet weekly for 12 weeks to cook, and engage in 
exercise and stress-reduction activities. This 3-month intervention will involve participants’ convening weekly 
for 12 consecutive weeks. Participants will be expected to attend baseline and post-intervention (i.e., 12-
weeks) clinic sessions. Intervention classes will meet on the same night at the same time for each of the 
weekly classes. Participants will have access to online material through our IMAGINE Healthy Online Portal 

and will be given take-home activities, referred to as IMAGINE actions. These homework assignments will 
focus on goal setting for nutrition, physical activity, and stress reduction. The dietary component of the classes 
will focus on increasing consumption of foods shown to decrease inflammation and limit consumption of foods 
that increase inflammation. A specific focus will be spent on watermelon. A total of 84 watermelon or 
watermelon components (e.g., seeds) are being developed as a focal point for this intervention. Participants 
will be expected to take part in hands-on cooking classes. Participants will be encouraged to obtain at least 30 
minutes of moderate intensity physical activity (equivalent to brisk walking) on at least five days of the week 
and to engage in at least two sessions of strength training each week. To ensure safety, participants will be 
encouraged to progress very gradually in increasing the intensity and duration of physical activity and only do 
so within their abilities. The Actigraph has been used extensively with respect to characterizing physical 
activity.22-28. Additionally, sleep characteristics can be obtained when participants wear the Actigraph during 
sleep, which will be a requirement of this study.29  Given the limited budget of this mechanism, the Actigraph 
will need to be provide in two waves. The first wave (about 8 of the intervention participants) will receive the 
Actigraphs at orientation. The remaining intervention participants will receive them at the baseline clinic. All 
intervention participants will have completed wearing the Actigraph by the first intervention class. Blood 
samples will be obtained from participants at baseline and after the 12-week intervention period. Additionally, a 
series of questionnaires also will be obtained at the two time points, as well as anthropometric measurements 
including a Bioelectric Impedance Analysis (BIA) scale which is very similar to a standard weight scale. Blood 
pressure also will be obtained. Participants will be expected to complete 4 24-hour dietary self-reports at each 
time point. This will be accomplished using the ASA24. All questionnaire data will be developed in Qualtrics, an 
online survey service. Therefore, all participants are expected to have access to the internet to complete all 
questionnaires. Additionally, the ASA24 must be completed online. 
 
Participant Expectations (Controls) 
Control participants will be selected from the same or similar sources as the intervention participants. The data 
collection will be the same between the intervention and control participants. The only difference is that the 
control participants will not be attending any intervention classes. Instead, this group will receive weekly health 
information. This information will be provided through email or mail, which can include weekly newsletters, 
healthy recipes that are not focused on reducing the DII scores, links to online content, and health-related 
event announcements in and around Columbia, SC. Any participants in the standard of care arm who do not 
use email regularly may request for items to be mailed to their mailing address. 
 
Sources of Materials 
Data collection points will be at baseline and after week 12 of participant involvement.  Baseline measurements 
will occur after the participant has been screened for eligibility and has signed the informed consent form as 
close to the first intervention session as possible.  Consistent measurements will occur for all participants.   
 
At each measurement point, the following sources of materials will be collected: 
• 
Informed consent form (at orientation session only; i.e., before any active involvement in the study) 
• 
Blood pressure reading 
• 
Anthropometric measurements, including height, weight, hip and waist circumference, and body fat 
percent using the BIA machine 
• 
Questionnaires via online Qualtrics 
• 
Diet (i.e. three 24-hour recalls) and physical activity logs indicating activities when the Actigraph 
armband is not worn 
• 
Actigraph monitor 
• 
Blood samples for CRP, HbA1c, insulin, and lipids (three eight-milliliter tubes will be collected). 
 
Project staff will record the blood pressure of intervention participants using a standard blood pressure cuff 
after the participant has been resting for 5 minutes.  Three readings will be taken with the second and third 
readings recorded. Staff also will measure body weight and height using an electronic scale and stadiometer, 
respectively. Hip and waist circumference will be measured using a Gulick measuring tape. Body 
composition will be obtained through BIA performed using the Tanita TBF-300WA Body Composition Analyzer 
(Arlington Heights, Illinois). Physical activity logs will be used to track participation in physical activity when the 
Actigraph is not worn. Participants height, weight, age, gender, smoking status, and handedness will be used 
to calibrate the Actigraph monitors. These monitors will be worn at all times and will only be taken off for 

bathing/showers or water activities. Participants will be provided the monitors for 7-10 days to ensure at least 4 
days of complete data. Complete data will be at least 23 reported hours of armband wear time or wear time 
plus information provided in the physical activity logs (e.g., supplementing wear time with time spent 
swimming). Blood samples will be collected by trained phlebotomists for characterization of the biomarkers 
identified above. Online questionnaires will be provided to all participants to complete at each data collection 
point. Project staff will assist with completion as necessary.  Questionnaires will include items to assess 
sociodemographic characteristics, health behaviors, social desirability and approval, self-reported physical 
activity, stress, depression, and confidence in the ability to make lifestyle changes. Self-report 24-hour dietary 
recalls will be used to obtain specific information on meals during the previous 24 hours using the ASA24. 
Lastly, participants will be provided with an online pass to our IMAGINE Healthy Online Portal to provide 
support and information in relationship to the weekly classes. Access to this material typically requires a fee. 
Therefore, the intervention participants will gain access through the study, but the controls will not be able to 
access this material. This limits the likelihood of “exposure contamination” by the controls.  
 
Participants, but not their invited partners, will be provided with a $20 incentive for baseline assessment 
measures and $20 incentive the 3-month measures. Control participants will receive the same incentives.  
 
Potential Risks 
Potential risks include the possibility that some questions included in the questionnaire may make some 
respondents feel uncomfortable (for example, inquiries about their diet, physical activity, smoking and alcohol 
habits). However, respondents may refuse to answer any question. The phlebotomy component carries a slight 
risk associated with venipuncture (redness, swelling, etc.). Phlebotomy will be undertaken by an experienced 
phlebotomist trained to minimize any risk associated with this portion of the study.  All blood draws will take 
place at USC’s CPCP by a trained phlebotomist.  There is virtually no risk to the subjects from the lab assays, 
which are routinely used in clinical practice. Participants may experience discomfort, irritation, or in rare cases, 
a skin reaction to the Actigraph (worn for 7 days 3 times during the study). However, it is very similar to a wrist 
watch and any reactions would be rare. We will discuss ways to limit irritation and instruct participants about 
discontinuing use if an allergic reaction occurs. The BIA machine carries virtually no risk. It is essentially the 
same as standing on a typical weight scale. However, in between each participant, the scale will be cleaned as 
it requires the participant to be bare-footed. The intervention itself is very unlikely to cause any serious harms. 
From our experience, we recognize that a healthy diet intervention will only aid in improving the health of our 
participants. We will encourage physical activity and provide education on physical activities. However, most of 
the physical activity will be performed outside of the study environment. Our experience has been that most 
subjects in our intervention studies in Columbia, South Carolina are pleased to be able to participate in health 
research.  
 
Statistical Analyses 
Sample characteristics were described by intervention condition using frequencies and means. Differences 
between groups at baseline were derived with Fisher’s exact test for categorical covariates given the small 
sample sizes. For continuous covariates, t-tests or Wilcoxon rank sums test, depending on normality, were 
used. Differences in daily average watermelon consumption were tested using t-tests.  
Outcomes included CRP, HbA1c percent, glucose, BMI, body fat percent, and body weight. Given the small 
sample size, it was not possible to conduct a confounder selection process. However, all models were adjusted 
for age. Using general linear models with repeated measurements with a compound symmetry covariance 
structure, least-square means of the outcomes by intervention status were obtained. Next, an interaction term 
was added to investigate the intervention-by-time effect. This process was conducted for each outcome.  
 
The IMAGINE-Watermelon program was designed to lower dietary inflammatory potential as measured by the 
E-DII. In theory, the intervention arm should have lowered their E-DII score (i.e., become more anti-
inflammatory) and the control arm should have stayed roughly the same. Adherence to the intervention 
assignment was examined based on change in the E-DII score. A post-hoc analysis was designed to examine 
whether a change to a more anti-inflammatory dietary pattern led to a change in inflammation regardless of 
intervention status. Participants were dichotomized at the median based on the change in their E-DII score 
from baseline to post-intervention. Those below the median had reductions in their E-DII scores (i.e., became 
more anti-inflammatory) and those above the median became more pro-inflammatory. For this post-hoc linear 
regression analysis, the independent variable was the change in the E-DII scores analyzed as both continuous 

and dichotomized at the median. Multiple least square regression was then performed to obtain least square 
means of the dependent variables by E-DII change adjusted for age. Additionally, the change in E-DII score 
was examined as a continuous measure where beta coefficients for a one-unit change in the E-DII score were 
reported. A one-unit increase in the change in E-DII score indicates a worsening of the E-DII score. 
 
Protection against Potential Risks 
All procedures used for data collection adhere to high standards of clinical or research practice or both. We 
have extensive experience with all procedures undertaken under this project. Confidentiality will be maintained 
by using the randomly assigned study number for each subject. Identifying information will be kept in secure 
locations (including password-protected computer files and locked file cabinets) with restricted access. All 
study staff members will have been trained using the CITI® protocol to ensure protection of patient privacy, and 
will be informed prior to the commencement of the study about the necessity for keeping all data confidential. 
Laboratory personnel will be blinded to the specific identity of the subjects, and will not be able to link any 
identifying information to the lab results. Analyses and publication of study results will concern group data only; 
it will not be possible to link any such results to information about any particular study participant or to deduce 
participant identity from published data. We note potential alternative to harms in the previous section for each 
of the data collection sources.  
 
Potential Benefits of the Proposed Research to the Participants and Others   
This study has the potential to confer benefit to the patient by reducing her or his chronic, systemic 
inflammation. Besides any direct health benefits conferred, the participant will receive a report of all data 
collected. The information we collect will be used to form the foundation of a future DII ‘App’ and counseling 
protocol and, as such therefore could inform approaches to prevent inflammation-related health problems in 
the U.S. (and elsewhere in the world). 
 
Importance of Knowledge to be Gained 
The knowledge generated by the research will provide an understanding of the effect of the developed 
program in improving diet and reducing inflammation from dietary sources. Additionally, this will help 
determine the effectiveness of focusing on specific foods, in this case watermelon, in our IMAGINE program.  
 
Inclusion of Women and Minorities   
All subjects will be U.S. citizens who are suspected of suffering from diet-associated chronic, systemic 
inflammation. The condition under study, chronic systemic inflammation is rampant in the US population; 
however, it is somewhat more prevalent among African Americans than in European Americans. Because we 
are recruiting from African-American churches and the general community of South Carolina, we expect that 
at least 75% of our population will be African American. Chronic, systemic inflammation afflicts both sexes and 
dietary quality, and therefore associated DII, will be well represented in both of the sexes. Therefore, we will 
attempt to recruit women and men in equal numbers. Men and women will be recruited and followed using the 
same procedures; therefore we anticipate that women and men will be recruited in the same numbers. 
 
Inclusion of Children   
Although children can suffer from diseases related to chronic inflammation these conditions and the underlying 
risk factors are much more common in adults. Therefore, children will not be enrolled in this research. 
 
 
 
 

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