CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 23 enrolled
Drug / intervention
DII-Based Counseling System +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03158740
NCT03158740N/ACompleted

A Watermelon Focused Dietary Inflammatory Index Counseling System to Reduce Systemic Inflammation

Michael D. Wirth·interventional·Posted May 18, 2017·Updated Oct 5, 2023

In Brief

A clinical study evaluating DII-Based Counseling System and general health education control for Inflammation and Diet Modification. Completed, enrolled 23 participants across 1 site.

Detailed Summary

A large, persuasive, and ever-increasing body of evidence links chronic inflammation to virtually all of the chronic diseases that cause the majority of disability and death in the U.S., including diabetes, cardiovascular diseases (CVD), and cancer. Diet plays a central role in the regulation of chronic inflammation. However, until investigators developed the Dietary Inflammatory Index (DII)TM there had been no scientifically valid way to relate what individuals eat to the capacity of foods consumed to modulate inflammation. The DII has now produced an impressive research base that ranges from predicting blood levels of inflammatory biomarkers; to a variety of health-related endpoints including cancer incidence and mortality, diabetes, and CVD; to psychological endpoints including depression and cognitive functioning. Watermelon is a member of the Cucurbitaceae family of gourds and is related to the cucumber, squash, and pumpkin. Watermelon flesh (WM) is \~91% water by weight, and is a rich source of bioavailable compounds including lycopene and other carotenoids, and vitamins A and C, all of which have anti-inflammatory properties. Watermelon is already known to play an effective role in reducing risk of chronic inflammation related conditions like coronary heart disease. Connecting Health Innovations (CHI) through this proposal is committed to developing a watermelon supplemented dietary intervention to reduce inflammation. The DII provides a tool that will form the basis of a counseling/instructional system aimed at helping patients and their providers to control chronic, systemic inflammation by improving the diet with specific, actionable dietary recommendations, counseling, and expert instruction. Our first aim is to refine and modify the DII-based intervention by developing and incorporating several watermelon recipes which will score low (anti-inflammatory) on the DII scale. Our second aim is to design and implement a two-arm intervention trial based on watermelon-focused DII recommendations aimed at reducing levels of chronic inflammation in Columbia, South Carolina; the two arms of this intervention study will be the DII-Based Counseling System, including access to our Imagine Healthy Online Portal, and a general health education control. Data will include questionnaires (e.g., demographics, health history, stress, depression, self-efficacy for physical activity and diet, social approval, social desirability), anthropometrics measures, physical activity monitoring, inflammatory marker C-reactive protein (CRP), and ASA 24-hour dietary recalls. Baseline data collection will be followed by a 12-week intervention period. The DII arm will receive in-person healthy cooking and nutrition classes, along with physical activity and stress reduction activities. Additionally, this arm will receive access to the Imagine Healthy Online Portal. The general health control arm will receive weekly health education information. Linear mixed models (LMM) will be used to determine whether the intervention arms are associated with the primary outcome (i.e., CRP).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 18, 2017
Enrollment StartJun 7, 2017
Primary CompletionSep 7, 2017
Study CompletionSep 14, 2017
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 9.1 years ago

Interventions

DII-Based Counseling Systembehavioral

DII-Based Counseling System, including 12 weekly classes in reducing inflammation by adopting dietary patterns low in inflammation and also through physical activity and stress reduction. Participants will also have access to our Imagine Healthy Online Portal. Group-based behavior change programs provide a way for members to share successes and obtain and provide support to one another.

general health education controlbehavioral

The standard of care arm will receive general health information (e.g., general guidelines of healthy eating and physical activity, stress management, cancer screening, etc.). This information will be provided through email, which will include a weekly newsletter, 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 does not use email regularly may request for items to be mailed to their mailing address.