search
Back to results

Developing the Dietary Inflammatory Index for Clinical Application (IMAGINE)

Primary Purpose

Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Newsletters on cancer prevention and control
Behavioral program to reduce inflammation
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Are actively engaged as patients in the medical practices of University Specialty Clinics (under the direction of Dr. Victor Hirth) or Eau Claire Cooperative Health Care System (under the direction of Dr. Stuart Hamilton) or has physician consent
  • Are ≥21 years of age;
  • Are willing and able to participate fully in the study for a period of one year; and
  • Are able to obtain travel to and from the intervention classes at the designated time.

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.

Sites / Locations

  • University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lifestyle intervention

Information intervention

Arm Description

Participants will receive a year-long comprehensive, dietary, exercise, and stress management intervention. They will be asked to bring a partner of their choosing with them for support. The intervention will include a behavioral program to reduce inflammation.

Participants will receive a year-long intervention that will involve receiving weekly (for the first 3 months) and then monthly (for the following 9 months) newsletters on cancer prevention and control (via e-mail or mail) that will provide the participant with information about cancer prevention and control strategies.

Outcomes

Primary Outcome Measures

Markers of inflammation assessed via blood samples
C-reactive protein

Secondary Outcome Measures

Changes in body weight assessed via digital scales
Changes in dietary intake assessed via three 24-hour dietary recalls
Markers of inflammation assessed via blood samples
Changes in body composition assessed via DXA

Full Information

First Posted
February 13, 2015
Last Updated
April 16, 2019
Sponsor
University of South Carolina
search

1. Study Identification

Unique Protocol Identification Number
NCT02382458
Brief Title
Developing the Dietary Inflammatory Index for Clinical Application
Acronym
IMAGINE
Official Title
Developing the Dietary Inflammatory Index for Clinical Application
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
February 28, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Diet plays a central role in the regulation of chronic inflammation. However, until the investigators developed the dietary inflammatory index (DII) there had been no scientifically valid way to relate what individuals eat to the capacity of foods consumed to modulate 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. The goal of this study is to test the applicability of a DII mobile tool and associated counseling measures in clinical practice.
Detailed Description
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 the investigators developed the dietary inflammatory index (DII) there had been no scientifically valid way to relate what individuals eat to the capacity of foods consumed to modulate inflammation. The new generation DII has now produced an impressive research base that ranges from predicting blood levels of inflammatory markers, to clinical conditions associated with inflammation, to a variety of health-related endpoints including cancer incidence, CVDs and mortality (several of which are already published). Connecting Health Innovations (CHI), LLC and the scientific and clinical research partners at the University of South Carolina are committed to translating these research findings to places of clinical need and public health relevance. That commitment to translation provides the motivation for the current proposal. 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. This project is part of Phase II of the grant, which includes: 1) Designing and implementing an intervention trial based on DII response associated recommendations aimed at reducing levels of chronic inflammation in two diverse populations in Columbia, South Carolina and 2) Providing data for developing methods for commercialization/ dissemination of the product and associated software.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle intervention
Arm Type
Experimental
Arm Description
Participants will receive a year-long comprehensive, dietary, exercise, and stress management intervention. They will be asked to bring a partner of their choosing with them for support. The intervention will include a behavioral program to reduce inflammation.
Arm Title
Information intervention
Arm Type
Active Comparator
Arm Description
Participants will receive a year-long intervention that will involve receiving weekly (for the first 3 months) and then monthly (for the following 9 months) newsletters on cancer prevention and control (via e-mail or mail) that will provide the participant with information about cancer prevention and control strategies.
Intervention Type
Behavioral
Intervention Name(s)
Newsletters on cancer prevention and control
Intervention Description
E-mailed or mailed newsletters that provide information on how to prevent cancer
Intervention Type
Behavioral
Intervention Name(s)
Behavioral program to reduce inflammation
Intervention Description
Group classes which will provide participants with information on achieving a healthy diet, increase physical activity, and manage stress
Primary Outcome Measure Information:
Title
Markers of inflammation assessed via blood samples
Description
C-reactive protein
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in body weight assessed via digital scales
Time Frame
52 weeks
Title
Changes in dietary intake assessed via three 24-hour dietary recalls
Time Frame
52 weeks
Title
Markers of inflammation assessed via blood samples
Time Frame
52 weeks
Title
Changes in body composition assessed via DXA
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Are actively engaged as patients in the medical practices of University Specialty Clinics (under the direction of Dr. Victor Hirth) or Eau Claire Cooperative Health Care System (under the direction of Dr. Stuart Hamilton) or has physician consent Are ≥21 years of age; Are willing and able to participate fully in the study for a period of one year; and Are able to obtain travel to and from the intervention classes at the designated time. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brie Turner-McGrievy
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32406919
Citation
Wirth MD, Jessup A, Turner-McGrievy G, Shivappa N, Hurley TG, Hebert JR. Changes in dietary inflammatory potential predict changes in sleep quality metrics, but not sleep duration. Sleep. 2020 Nov 12;43(11):zsaa093. doi: 10.1093/sleep/zsaa093.
Results Reference
derived
PubMed Identifier
30904228
Citation
Turner-McGrievy GM, Wirth MD, Shivappa N, Dunn CG, Crimarco A, Hurley TG, West DS, Hussey JR, Hebert JR. Impact of a 12-month Inflammation Management Intervention on the Dietary Inflammatory Index, inflammation, and lipids. Clin Nutr ESPEN. 2019 Apr;30:42-51. doi: 10.1016/j.clnesp.2019.02.008. Epub 2019 Mar 1.
Results Reference
derived

Learn more about this trial

Developing the Dietary Inflammatory Index for Clinical Application

We'll reach out to this number within 24 hrs