Trial Outcomes & Findings for Watermelon Focused Dietary Inflammatory Index Intervention (NCT NCT03158740)

NCT ID: NCT03158740

Last Updated: 2023-10-05

Results Overview

Investigators will examine if there is a change in the levels of CRP from baseline to 3 months.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

baseline and three months

Results posted on

2023-10-05

Participant Flow

Participant milestones

Participant milestones
Measure
DII-Based Counseling System
The DII-based counseling group will utilize our 12-week IMAGINE Counseling System curriculum.The DII-based counseling group will meet once a week for 12 weeks to cook, and to engage in exercise and stress-reduction activities. Along with the initial clinic, participants will meet one-on-one for a nutrition counseling session with a registered dietitian. 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 nutrition components of this intervention will be based on the DII and will focus on anti-inflammatory foods and components. DII-Based Counseling System: 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 Control
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. general health education control: 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.
Overall Study
STARTED
15
8
Overall Study
COMPLETED
11
7
Overall Study
NOT COMPLETED
4
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Watermelon Focused Dietary Inflammatory Index Intervention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
DII-Based Counseling System
n=15 Participants
The DII-based counseling group will utilize our 12-week IMAGINE Counseling System curriculum.The DII-based counseling group will meet once a week for 12 weeks to cook, and to engage in exercise and stress-reduction activities. Along with the initial clinic, participants will meet one-on-one for a nutrition counseling session with a registered dietitian. 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 nutrition components of this intervention will be based on the DII and will focus on anti-inflammatory foods and components. DII-Based Counseling System: 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 Control
n=8 Participants
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. general health education control: 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.
Total
n=23 Participants
Total of all reporting groups
Age, Continuous
55.9 years
STANDARD_DEVIATION 15.1 • n=99 Participants
33.8 years
STANDARD_DEVIATION 15.1 • n=107 Participants
48.2 years
STANDARD_DEVIATION 16.7 • n=206 Participants
Sex: Female, Male
Female
13 Participants
n=99 Participants
6 Participants
n=107 Participants
19 Participants
n=206 Participants
Sex: Female, Male
Male
2 Participants
n=99 Participants
2 Participants
n=107 Participants
4 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
2 Participants
n=99 Participants
2 Participants
n=107 Participants
4 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
11 Participants
n=99 Participants
0 Participants
n=107 Participants
11 Participants
n=206 Participants
Race (NIH/OMB)
White
2 Participants
n=99 Participants
6 Participants
n=107 Participants
8 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Region of Enrollment
United States
15 participants
n=99 Participants
8 participants
n=107 Participants
23 participants
n=206 Participants

PRIMARY outcome

Timeframe: baseline and three months

Population: Below is the mean difference and standard error between pre and post follow-up for each group.

Investigators will examine if there is a change in the levels of CRP from baseline to 3 months.

Outcome measures

Outcome measures
Measure
DII-Based Counseling System
n=11 Participants
The DII-based counseling group will utilize our 12-week IMAGINE Counseling System curriculum.The DII-based counseling group will meet once a week for 12 weeks to cook, and to engage in exercise and stress-reduction activities. Along with the initial clinic, participants will meet one-on-one for a nutrition counseling session with a registered dietitian. 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 nutrition components of this intervention will be based on the DII and will focus on anti-inflammatory foods and components. DII-Based Counseling System: 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 Control
n=7 Participants
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. general health education control: 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.
Change in C-reactive Protein
-0.04 mg/L
Standard Error 0.35
-0.56 mg/L
Standard Error 0.46

SECONDARY outcome

Timeframe: baseline and three months

Investigators will examine if there is change in the levels of HbA1C from baseline to 3 months.

Outcome measures

Outcome measures
Measure
DII-Based Counseling System
n=11 Participants
The DII-based counseling group will utilize our 12-week IMAGINE Counseling System curriculum.The DII-based counseling group will meet once a week for 12 weeks to cook, and to engage in exercise and stress-reduction activities. Along with the initial clinic, participants will meet one-on-one for a nutrition counseling session with a registered dietitian. 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 nutrition components of this intervention will be based on the DII and will focus on anti-inflammatory foods and components. DII-Based Counseling System: 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 Control
n=7 Participants
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. general health education control: 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.
Change in Haemoglobin A1C
0.00 percentage of HbA1c
Standard Error 0.05
-0.02 percentage of HbA1c
Standard Error 0.06

SECONDARY outcome

Timeframe: Baseline to 3 months

Investigators will examine if there is a change in the levels of glucose from baseline to 3 months.

Outcome measures

Outcome measures
Measure
DII-Based Counseling System
n=11 Participants
The DII-based counseling group will utilize our 12-week IMAGINE Counseling System curriculum.The DII-based counseling group will meet once a week for 12 weeks to cook, and to engage in exercise and stress-reduction activities. Along with the initial clinic, participants will meet one-on-one for a nutrition counseling session with a registered dietitian. 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 nutrition components of this intervention will be based on the DII and will focus on anti-inflammatory foods and components. DII-Based Counseling System: 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 Control
n=7 Participants
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. general health education control: 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.
Change in Glucose
-0.84 mg/dL
Standard Error 2.82
4.29 mg/dL
Standard Error 3.57

SECONDARY outcome

Timeframe: Baseline to 3 months

Investigators will examine if there is a change in the levels of BMI from baseline to 3 months.

Outcome measures

Outcome measures
Measure
DII-Based Counseling System
n=11 Participants
The DII-based counseling group will utilize our 12-week IMAGINE Counseling System curriculum.The DII-based counseling group will meet once a week for 12 weeks to cook, and to engage in exercise and stress-reduction activities. Along with the initial clinic, participants will meet one-on-one for a nutrition counseling session with a registered dietitian. 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 nutrition components of this intervention will be based on the DII and will focus on anti-inflammatory foods and components. DII-Based Counseling System: 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 Control
n=7 Participants
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. general health education control: 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.
Change in BMI
-0.10 kg/(m*m)
Standard Error 0.35
0.13 kg/(m*m)
Standard Error 0.43

SECONDARY outcome

Timeframe: baseline to 3 months

Investigators will examine if there is a change in the levels of body fat percent from baseline to 3 months.

Outcome measures

Outcome measures
Measure
DII-Based Counseling System
n=11 Participants
The DII-based counseling group will utilize our 12-week IMAGINE Counseling System curriculum.The DII-based counseling group will meet once a week for 12 weeks to cook, and to engage in exercise and stress-reduction activities. Along with the initial clinic, participants will meet one-on-one for a nutrition counseling session with a registered dietitian. 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 nutrition components of this intervention will be based on the DII and will focus on anti-inflammatory foods and components. DII-Based Counseling System: 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 Control
n=7 Participants
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. general health education control: 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.
Change in Body Fat Percent
0.43 percentage of body fat
Standard Error 0.54
-0.77 percentage of body fat
Standard Error 0.71

SECONDARY outcome

Timeframe: baseline to 3 months

Investigators will examine if there is a change in the levels of body weight from baseline to 3 months.

Outcome measures

Outcome measures
Measure
DII-Based Counseling System
n=11 Participants
The DII-based counseling group will utilize our 12-week IMAGINE Counseling System curriculum.The DII-based counseling group will meet once a week for 12 weeks to cook, and to engage in exercise and stress-reduction activities. Along with the initial clinic, participants will meet one-on-one for a nutrition counseling session with a registered dietitian. 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 nutrition components of this intervention will be based on the DII and will focus on anti-inflammatory foods and components. DII-Based Counseling System: 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 Control
n=7 Participants
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. general health education control: 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.
Change in Body Weight
-0.24 kg
Standard Error 1.22
-0.14 kg
Standard Error 1.61

Adverse Events

DII-Based Counseling System

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

General Health Education Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Scientist

Connecting Health Innovations

Phone: 8649154636

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place