Trial Outcomes & Findings for Interventions in Nutrition Education and Skills (NCT NCT02924051)
NCT ID: NCT02924051
Last Updated: 2019-07-22
Results Overview
Block Fruit/Vegetable/Fiber Screener is a tool that ranks usual intake of fruit, vegetables, and fiber. Total fruit/vegetable/fiber score can range from 0-50 with higher numbers reflecting greater frequency of fruit, vegetable and fiber consumption.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
188 participants
Primary outcome timeframe
Baseline, 12 months
Results posted on
2019-07-22
Participant Flow
Participant milestones
| Measure |
Cooking Skills/Nutrition Education
Control group received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families.
|
Cooking Skills/Nutrition Education/Motivational Interviewing
Intervention group participants received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families, along with monthly motivational interviewing conducted by a trained registered nurse.
Motivational Interviewing: Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and "coaching" to resolve barriers and ambivalence.
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
106
|
|
Overall Study
COMPLETED
|
81
|
97
|
|
Overall Study
NOT COMPLETED
|
1
|
9
|
Reasons for withdrawal
| Measure |
Cooking Skills/Nutrition Education
Control group received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families.
|
Cooking Skills/Nutrition Education/Motivational Interviewing
Intervention group participants received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families, along with monthly motivational interviewing conducted by a trained registered nurse.
Motivational Interviewing: Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and "coaching" to resolve barriers and ambivalence.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
9
|
Baseline Characteristics
Interventions in Nutrition Education and Skills
Baseline characteristics by cohort
| Measure |
Control
n=82 Participants
Control group received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to families.
|
Intervention
n=106 Participants
Intervention group participants received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families, along with monthly motivational interviewing conducted by a trained registered nurse.
Motivational Interviewing: Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and "coaching" to resolve barriers and ambivalence.
|
Total
n=188 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.4 years
n=5 Participants
|
50.3 years
n=7 Participants
|
54.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
79 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
82 participants
n=5 Participants
|
106 participants
n=7 Participants
|
188 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 monthsPopulation: Participants who completed the Block Screener at baseline and post-intervention (12 months)
Block Fruit/Vegetable/Fiber Screener is a tool that ranks usual intake of fruit, vegetables, and fiber. Total fruit/vegetable/fiber score can range from 0-50 with higher numbers reflecting greater frequency of fruit, vegetable and fiber consumption.
Outcome measures
| Measure |
Cooking Skills/Nutrition Education
n=54 Participants
Control group received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to families.
|
Cooking Skills/Nutrition Education/Motivational Interviewing
n=60 Participants
Intervention group participants received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families, along with monthly motivational interviewing conducted by a trained registered nurse.
Motivational Interviewing: Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and "coaching" to resolve barriers and ambivalence.
|
|---|---|---|
|
Change in BLOCK Fruit/Vegetable/Fiber Screener From Baseline at 12 Months
Baseline
|
16.6 units on a scale
Interval 2.0 to 34.0
|
15.9 units on a scale
Interval 5.0 to 30.0
|
|
Change in BLOCK Fruit/Vegetable/Fiber Screener From Baseline at 12 Months
12 months
|
18.0 units on a scale
Interval 6.0 to 35.0
|
16.3 units on a scale
Interval 6.0 to 29.0
|
SECONDARY outcome
Timeframe: Baseline, 12 monthsPopulation: Number of participants completing the NCI DHQ II survey
Using the NCI DHQ II, respondents' frequency of consumption of foods (i.e., meats and oils) and portion size, dietary saturated fat consumption was calculated as average grams/day. Higher grams/day reflect higher consumption of saturated fatty acids.
Outcome measures
| Measure |
Cooking Skills/Nutrition Education
n=32 Participants
Control group received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to families.
|
Cooking Skills/Nutrition Education/Motivational Interviewing
n=36 Participants
Intervention group participants received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families, along with monthly motivational interviewing conducted by a trained registered nurse.
Motivational Interviewing: Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and "coaching" to resolve barriers and ambivalence.
|
|---|---|---|
|
Average Saturated Fatty Acid Intake/Day
Baseline
|
26.8 grams/day
Standard Deviation 15.4
|
23.8 grams/day
Standard Deviation 14.3
|
|
Average Saturated Fatty Acid Intake/Day
Post-Intervention (12 mos)
|
19.2 grams/day
Standard Deviation 9.6
|
21.6 grams/day
Standard Deviation 17.9
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Participants completing the NCI DHQ II question related fast food comsumpsion
Fast food consumption was measured using a single item on the National Cancer Institute Diety History Questionaire (NCI DHQ II) "How often did you eat beef hamburgers or cheeseburgers from a fast food or other restaurant?" Responses are selected from 11 pre-determined options increasing in frequency from "never" to "2 or more times per day." Values range from 0 to 10; higher values indicate an increased frequency of fast food consumption.
Outcome measures
| Measure |
Cooking Skills/Nutrition Education
n=27 Participants
Control group received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to families.
|
Cooking Skills/Nutrition Education/Motivational Interviewing
n=38 Participants
Intervention group participants received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families, along with monthly motivational interviewing conducted by a trained registered nurse.
Motivational Interviewing: Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and "coaching" to resolve barriers and ambivalence.
|
|---|---|---|
|
Frequency of Fast Food Consumption
12 months
|
3.78 units on a scale
Standard Error 0.50
|
3.03 units on a scale
Standard Error 0.46
|
|
Frequency of Fast Food Consumption
Baseline
|
3.56 units on a scale
Standard Error .49
|
3.16 units on a scale
Standard Error 0.53
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place