Trial Outcomes & Findings for Healthy Eating for Colon Cancer Prevention (NCT NCT00475722)

NCT ID: NCT00475722

Last Updated: 2016-09-26

Results Overview

Percentage of participants who met 70% of diet goals as outlined in the exchange list

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 120 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2016-09-26

Participant Flow

Participant milestones

Measure	1 Healthy Eating Healthy People 2010 Diet Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling	2 Mediterranean Mediterranean Diet Mediterranean Diet through dietary counseling: 6 months telephone counseling
Overall Study STARTED	61	59
Overall Study COMPLETED	46	47
Overall Study NOT COMPLETED	15	12

Reasons for withdrawal

Measure	1 Healthy Eating Healthy People 2010 Diet Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling	2 Mediterranean Mediterranean Diet Mediterranean Diet through dietary counseling: 6 months telephone counseling
Overall Study Withdrawal by Subject	12	12
Overall Study Protocol Violation	3	0

Baseline Characteristics

Healthy Eating for Colon Cancer Prevention

Baseline characteristics by cohort

Measure	1 Healthy Eating n=61 Participants Healthy People 2010 Diet using an exchange list 1 Healthy Eating: 6 months telephone counseling	2 Mediterranean n=59 Participants Mediterranean Diet using an exchange list 2 Mediterranean: 6 months telephone counseling	Total n=120 Participants Total of all reporting groups
Age, Continuous	51 years STANDARD_DEVIATION 13 • n=93 Participants	55 years STANDARD_DEVIATION 10 • n=4 Participants	53 years STANDARD_DEVIATION 12 • n=27 Participants
Sex: Female, Male Female	43 Participants n=93 Participants	43 Participants n=4 Participants	86 Participants n=27 Participants
Sex: Female, Male Male	18 Participants n=93 Participants	16 Participants n=4 Participants	34 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	61 Participants n=93 Participants	58 Participants n=4 Participants	119 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	6 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) White	55 Participants n=93 Participants	52 Participants n=4 Participants	107 Participants n=27 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	61 participants n=93 Participants	59 participants n=4 Participants	120 participants n=27 Participants

PRIMARY outcome

Timeframe: 6 months

Percentage of participants who met 70% of diet goals as outlined in the exchange list

Outcome measures

Measure	1 Healthy Eating n=61 Participants Healthy People 2010 Diet Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling	2 Mediterranean n=59 Participants Mediterranean Diet Mediterranean Diet through dietary counseling: 6 months telephone counseling
Adherence to Dietary Goals	89 percentage of participants meeting goals	85 percentage of participants meeting goals

Adverse Events

1 Healthy Eating

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

2 Mediterranean

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	1 Healthy Eating n=61 participants at risk Healthy People 2010 Diet Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling	2 Mediterranean n=59 participants at risk Mediterranean Diet Mediterranean Diet through dietary counseling: 6 months telephone counseling
Gastrointestinal disorders surgery	0.00% 0/61 • 5 years	1.7% 1/59 • Number of events 1 • 5 years
Psychiatric disorders bipolar relapse	0.00% 0/61 • 5 years	1.7% 1/59 • Number of events 1 • 5 years

Other adverse events

Measure	1 Healthy Eating n=61 participants at risk Healthy People 2010 Diet Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling	2 Mediterranean n=59 participants at risk Mediterranean Diet Mediterranean Diet through dietary counseling: 6 months telephone counseling
Infections and infestations various minor conditions	24.6% 15/61 • Number of events 15 • 5 years	30.5% 18/59 • Number of events 18 • 5 years

Additional Information

Dr. Zora Djuric

University of Michigan

Phone: 734-615-6210

Email: zoralong@umich.edu

Results disclosure agreements

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