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.
COMPLETED
NA
23 participants
baseline and three months
2023-10-05
Participant Flow
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.
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|---|---|---|
|
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
| 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 monthsPopulation: 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
| 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 monthsInvestigators will examine if there is change in the levels of HbA1C from baseline to 3 months.
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 monthsInvestigators will examine if there is a change in the levels of glucose from baseline to 3 months.
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.
|
|---|---|---|
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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 monthsInvestigators will examine if there is a change in the levels of BMI from baseline to 3 months.
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 monthsInvestigators will examine if there is a change in the levels of body fat percent from baseline to 3 months.
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 monthsInvestigators will examine if there is a change in the levels of body weight from baseline to 3 months.
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
General Health Education Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place