Trial Outcomes & Findings for Well-child Visit Video Project (NCT NCT05011292)
NCT ID: NCT05011292
Last Updated: 2024-06-20
Results Overview
This will be assessed by asking parents if they are "aware of any expert recommendations related to the age or amount of fruit juice given to infants and/or young children?". Those responding "yes" will be asked to specify the recommendation. If their response is correct, they will be recorded as knowledgeable.
COMPLETED
NA
388 participants
0-3 months post-intervention
2024-06-20
Participant Flow
Participant milestones
| Measure |
Control Group
The control group includes parents that will view an educational video and respond to survey questions about a topic other than infant SCB consumption (4 or 12-month well-child visit) or complete an infant feeding assessment survey (6-, or 15-month well-child visit).
|
Intervention Group
The intervention group includes parents that view a SCB-reduction video while attending their child's 4-month or 12-month well-child visit.
|
Clinical Staff
Clinical Staff providing the video to the study participants during clinic operations were asked to answer a few written and verbal questions regarding the well-child visit videos presented in the clinic.
|
|---|---|---|---|
|
Overall Study
STARTED
|
116
|
267
|
5
|
|
Overall Study
COMPLETED
|
116
|
56
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
211
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Well-child Visit Video Project
Baseline characteristics by cohort
| Measure |
Control Group
n=116 Participants
The control group includes parents that will view an educational video about a topic other than infant SCB consumption (4 or 12-month well-child visit) and respond to survey questions or complete an infant feeding assessment survey (6, or 15-month well-child visit).
|
Intervention Group
n=267 Participants
The intervention group includes parents that view a SCB-reduction video while attending their child's 4-month or 12-month well-child visit.
|
Clinical Staff
Clinical Staff providing the video to the study participants during clinic operations were asked to answer a few written and verbal questions regarding the well-child visit videos presented in the clinic.
|
Total
n=383 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
85 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
—
|
298 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
31 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
—
|
85 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
231 Participants
n=7 Participants
|
—
|
335 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
—
|
48 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
—
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
110 Participants
n=5 Participants
|
258 Participants
n=7 Participants
|
—
|
368 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
105 Participants
n=5 Participants
|
238 Participants
n=7 Participants
|
—
|
343 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
—
|
37 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
—
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
116 participants
n=5 Participants
|
267 participants
n=7 Participants
|
—
|
383 participants
n=4 Participants
|
|
Number of participants that viewed and completed survey on perceptions of educational video
|
62 Participants
n=5 Participants
|
267 Participants
n=7 Participants
|
—
|
329 Participants
n=4 Participants
|
|
Number of participants that completed and infant feeding practices survey
|
54 Participants
n=5 Participants
|
267 Participants
n=7 Participants
|
—
|
321 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0-3 months post-interventionPopulation: For the control Group: Include participants that complete the fruit juice recommendation question on the infant feeding assessment survey. For the Intervention Group: Includes only those who viewed the intervention video at their child's 4-month or 12-month well child visit and who attend their 6-month or 15-month well-child visit and complete the fruit juice recommendation question on the infant feeding survey.
This will be assessed by asking parents if they are "aware of any expert recommendations related to the age or amount of fruit juice given to infants and/or young children?". Those responding "yes" will be asked to specify the recommendation. If their response is correct, they will be recorded as knowledgeable.
Outcome measures
| Measure |
Control Group
n=46 Participants
The control group includes parents that will view an educational video about a topic other than infant SCB consumption (4 or 12-month well-child visit) or complete an infant feeding assessment survey (6, or 15-month well-child visit).
|
Intervention Group
n=44 Participants
The intervention group includes parents that view a SCB-reduction video while attending their child's 4-month or 12-month well-child visit.
|
|---|---|---|
|
Percentage of Parents Who Are Aware of Infant Fruit Juice Consumption Recommendations
|
19.57 percentage of participants
|
27.27 percentage of participants
|
PRIMARY outcome
Timeframe: 2-3 months post-interventionPopulation: For the Control group: parents attending their child's 6-month well-child visit and responding to the survey question about their child's fruit consumption. For the Intervention Group: Participants include those that viewed a video at the 4-month visit, attend the 6-month visit, and respond to the survey question about their child's fruit juice consumption.
Parents will be asked if they give their young child fruit juice. Response options will be "yes" or "no". Participants responding "no" are reported.
Outcome measures
| Measure |
Control Group
n=36 Participants
The control group includes parents that will view an educational video about a topic other than infant SCB consumption (4 or 12-month well-child visit) or complete an infant feeding assessment survey (6, or 15-month well-child visit).
|
Intervention Group
n=38 Participants
The intervention group includes parents that view a SCB-reduction video while attending their child's 4-month or 12-month well-child visit.
|
|---|---|---|
|
Percentage of Parents Who Report That They do Not Give Their Young Children Fruit Juice
|
58.3 percentage of participants
|
60.5 percentage of participants
|
PRIMARY outcome
Timeframe: 2-3 months post-interventionPopulation: For the Control Group: Includes parents of participants attending their child's 15-month well-child visit and responding to the survey question about their child's sugar-sweetened beverage consumption. For the Intervention Group: Participants include those that viewed a video at the 12-month visit, attend the 15-month visit, and respond to the survey question about their child's sugar-sweetened beverage consumption.
Parents will be asked if they give their young child sugar-sweetened beverages. Response options will be "yes" or "no". Percentage of parents who report"no" will be reported.
Outcome measures
| Measure |
Control Group
n=12 Participants
The control group includes parents that will view an educational video about a topic other than infant SCB consumption (4 or 12-month well-child visit) or complete an infant feeding assessment survey (6, or 15-month well-child visit).
|
Intervention Group
n=9 Participants
The intervention group includes parents that view a SCB-reduction video while attending their child's 4-month or 12-month well-child visit.
|
|---|---|---|
|
Percentage of Parents Who Report That They do Not Give Their Young Children Sugar-sweetened Beverages.
|
8.3 percentage of participants
|
55.6 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 9 months post-interventionThis outcome will be assessed with the key informant survey that specifically asks if staff found it "easy to integrate the videos into the flow of clinic operations". Positive responses will be reported.
Outcome measures
| Measure |
Control Group
n=5 Participants
The control group includes parents that will view an educational video about a topic other than infant SCB consumption (4 or 12-month well-child visit) or complete an infant feeding assessment survey (6, or 15-month well-child visit).
|
Intervention Group
The intervention group includes parents that view a SCB-reduction video while attending their child's 4-month or 12-month well-child visit.
|
|---|---|---|
|
Percentage of Clinic Staff Who Report That the SCB Consumption Related Videos Were Easy to Incorporate Into the Flow of Clinic Operations
|
80 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: immediately post-intervention, within 30 minutesPopulation: The Intervention Group includes participants that viewed a video at their child's 4-month or 12-month visit.
Parents will be asked specifically if they "enjoyed the video". Responses will be on a 5-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree". Percentage of parents who "agree" or "strongly agree" are reported.
Outcome measures
| Measure |
Control Group
n=62 Participants
The control group includes parents that will view an educational video about a topic other than infant SCB consumption (4 or 12-month well-child visit) or complete an infant feeding assessment survey (6, or 15-month well-child visit).
|
Intervention Group
n=267 Participants
The intervention group includes parents that view a SCB-reduction video while attending their child's 4-month or 12-month well-child visit.
|
|---|---|---|
|
Percentage of Parents Who Viewed an Intervention Video Report That They Enjoyed it
|
87 percentage of participants
|
95.9 percentage of participants
|
SECONDARY outcome
Timeframe: immediately post-intervention, within 30 minutesPopulation: The Control Group includes participants attending the child's 4-month or 12-month well-child visit. The Intervention Group includes participants that viewed a video at their child's 4-month or 12-month visit.
Parents will be asked specifically if they "learned something" from it. Responses will be on a 5-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree". Percentage of parents who "agree" or "strongly agree" are reported.
Outcome measures
| Measure |
Control Group
n=62 Participants
The control group includes parents that will view an educational video about a topic other than infant SCB consumption (4 or 12-month well-child visit) or complete an infant feeding assessment survey (6, or 15-month well-child visit).
|
Intervention Group
n=267 Participants
The intervention group includes parents that view a SCB-reduction video while attending their child's 4-month or 12-month well-child visit.
|
|---|---|---|
|
Percentage of Parents Who Viewed an Intervention Video Report That They Learned Something From it
|
83.9 percentage of participants
|
95.5 percentage of participants
|
Adverse Events
Control Group
Intervention Group
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