Trial Outcomes & Findings for Individual Counseling and/or Computer-Based Counseling in Helping Healthy Women Adopt a Cancer Prevention Diet (NCT NCT00217490)
NCT ID: NCT00217490
Last Updated: 2017-04-04
Results Overview
Self reported dietary change in consumption as collected via Block Food Frequency Questionnaire (FFQ) servings of fruit or vegetable per day and average fat consumption. This FFQ asks participants to recall their average consumption of various categories of food during the previous three months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
621 participants
Primary outcome timeframe
Baseline and 3 months
Results posted on
2017-04-04
Participant Flow
Women in Kaiser Permanente were identified from the electronic medical record and sent a letter inviting them to participate in the study. Recruitment started in 2003
Women who agreed to come in for the initial visit and randomization were excluded if they were not willing to change diet or physical activity, could not speak and read English.
Participant milestones
| Measure |
Computer Only
Dietary Counseling delivered by interactive computer
|
Counseling Only
Dietary counseling delivered by nutritionist
|
Combined
Dietary counseling delivered using computer program and nutritionist
|
Physcial Activity-computer
Physical activity counseling delivered by computer only
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
154
|
153
|
155
|
153
|
|
Overall Study
COMPLETED
|
137
|
128
|
131
|
130
|
|
Overall Study
NOT COMPLETED
|
17
|
25
|
24
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Individual Counseling and/or Computer-Based Counseling in Helping Healthy Women Adopt a Cancer Prevention Diet
Baseline characteristics by cohort
| Measure |
Computer Only
n=154 Participants
Dietary Counseling delivered by interactive computer
|
Counseling Only
n=153 Participants
Dietary counseling delivered by nutritionist
|
Combined
n=155 Participants
Dietary counseling delivered using computer program and nutritionist
|
Physcial Activity-computer
n=153 Participants
Physical activity counseling delivered by computer only
|
Total
n=615 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
144 Participants
n=99 Participants
|
143 Participants
n=107 Participants
|
143 Participants
n=206 Participants
|
144 Participants
n=7 Participants
|
574 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
41 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
154 Participants
n=99 Participants
|
153 Participants
n=107 Participants
|
155 Participants
n=206 Participants
|
153 Participants
n=7 Participants
|
615 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
145 Participants
n=99 Participants
|
148 Participants
n=107 Participants
|
147 Participants
n=206 Participants
|
146 Participants
n=7 Participants
|
586 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
48 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
132 Participants
n=99 Participants
|
131 Participants
n=107 Participants
|
135 Participants
n=206 Participants
|
129 Participants
n=7 Participants
|
527 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
154 participants
n=99 Participants
|
153 participants
n=107 Participants
|
155 participants
n=206 Participants
|
153 participants
n=7 Participants
|
615 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: Participant who returned for follow up visit
Self reported dietary change in consumption as collected via Block Food Frequency Questionnaire (FFQ) servings of fruit or vegetable per day and average fat consumption. This FFQ asks participants to recall their average consumption of various categories of food during the previous three months.
Outcome measures
| Measure |
Computer Only
n=137 Participants
Dietary Counseling delivered by interactive computer
dietary counseling via computer: An interactive computer program that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
|
Counseling Only
n=128 Participants
Dietary counseling delivered by nutritionist
dietary counseling via nutritionist: A one on one counseling sessions to addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
|
Combined
n=131 Participants
Dietary counseling delivered using computer program and nutritionist
combined computer and nutritionist: An interactive computer program plus one on one nutrition counseling that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
|
Physcial Activity-computer
n=130 Participants
Physical activity counseling delivered by computer only
physical activity counseling via computer: An interactive computer program that addresses increase to physical activity, barriers to change and possible solution to barriers to develop an action plan
|
|---|---|---|---|---|
|
Change in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months
|
2.7272727 number of servings per day
Standard Deviation 2.7480483
|
2.9758065 number of servings per day
Standard Deviation 2.8426456
|
2.7330645 number of servings per day
Standard Deviation 2.7742053
|
0.4720000 number of servings per day
Standard Deviation 2.2229594
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: Participants who returned for follow up visit
Self reported dietary change in consumption as collected via Block Food Frequency Questionnaire (FFQ) servings of fruit or vegetable per day and average fat consumption. This FFQ asks participants to recall their average consumption of various categories of food during the previous three months.
Outcome measures
| Measure |
Computer Only
n=132 Participants
Dietary Counseling delivered by interactive computer
dietary counseling via computer: An interactive computer program that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
|
Counseling Only
n=124 Participants
Dietary counseling delivered by nutritionist
dietary counseling via nutritionist: A one on one counseling sessions to addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
|
Combined
n=124 Participants
Dietary counseling delivered using computer program and nutritionist
combined computer and nutritionist: An interactive computer program plus one on one nutrition counseling that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
|
Physcial Activity-computer
n=125 Participants
Physical activity counseling delivered by computer only
physical activity counseling via computer: An interactive computer program that addresses increase to physical activity, barriers to change and possible solution to barriers to develop an action plan
|
|---|---|---|---|---|
|
Change in Percentage of Fat Consumed
|
-4.653333 Percentage of fat consumed
Standard Deviation 7.4788051
|
-5.3439516 Percentage of fat consumed
Standard Deviation 7.3594025
|
-6.0113710 Percentage of fat consumed
Standard Deviation 6.9703683
|
-1.4154400 Percentage of fat consumed
Standard Deviation 7.9831426
|
Adverse Events
Computer Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Counseling Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Combined
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Physcial Activity-computer
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
Victor J. Stevens, PhD
Kaiser Permanente Center for Health Research
Phone: 503 335 6751
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place