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Well-child Visit Video Project

Strengthening and Supporting the Diabetes Early Prevention Efforts of Pediatric Primary Healthcare Providers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05011292
Enrollment
388
Registered
2021-08-18
Start date
2021-08-10
Completion date
2023-05-01
Last updated
2024-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Prevention, Type 2 Diabetes

Brief summary

The purpose of this study is to determine if incorporating videos on the importance of minimizing infant sugar-containing beverage (SCB) consumption into well-child visit protocols increases parents' SCB-related knowledge and their compliance with related early feeding recommendations. The study also aims to determine whether these videos increase the frequency and quality of the SCB-related reduction education and counseling provided to parents during well-child visits.

Detailed description

The purpose of this study is to determine if incorporating videos on the importance of minimizing infant sugar-containing beverage (SCB) consumption into well-child visit protocols increases parents' SCB-related knowledge and their compliance with related early feeding recommendations. The study also aims to determine whether these videos increase the frequency and quality of the SCB-related reduction education and counseling provided to parents during well-child visits. The populations to be studied include: 1. Parents of children attending a 4, 6, 9, 12 or 15-month well-child visit (Main study) 2. A subsample of parents from above that agree to complete a baseline and follow-up knowledge and practice survey 5 to 6 months after enrollment. (Long-Term follow-up study) 3. Members of the clinic team who participate in the project (Key informant interviews) Participants in the main study will include parents attending a 4-month, 6-month, 9-month, 12-month or 15-month well-child visit at Hughes Spalding clinic, Atlanta GA. During their 4-month or 12-month clinic visit, parents will be offered to view a video (3 minutes) and complete a short survey about it afterwards (2 minutes). Parents attending their child's 6, 9 or 15-month well-child visit will be asked to complete a short survey about infant feeding practices (3-4 minutes). No identifying information will be collected. A waiver of consent is being requested for this component of the study. A subsample of the parents referenced above will be invited by co-investigators on the clinic team to participate in a long-term follow-up survey to assess the extent to which viewing the well-child visit videos has an impact of knowledge and/or behavior that is sustained. Those who consent will be asked to provide their first name and email address in order to enable the follow up survey to be completed on-line. No other PHI will be collected. A study ID will be assigned and only the PI and the statistician will have access to the code that links identifiers to subjects. Sub sample participants will be asked to view a video at the child's 4-month or 12-month well-child visit, to complete a survey assessing their response to the video as well as their infant feeding practices. This survey will be repeated during their 6-month or 15-month well-child visit and again, by email, 2 to 3 months later. Total participation time is expected to be \<20 minutes. Key informant interviews will be completed by members of the clinic team involved in the various aspects of the study. These will be done as time allows and will involved discussions of 5 to 30 minutes depending on the availability of the staff members. No identifying information will be collected as part of these interviews. The general scope of topics covered in the surveys and key informant interviews will be attitudes toward the sugar-containing beverage reduction (SCB) videos played at the clinic as well as SCB knowledge and practices of parents and their children. Participant burden for parents will range from about 6 minutes for those completing only the initial survey to an estimated 20 minutes for the sub-sample of parents involved in the long-term follow-up. Clinic staff that are involved in the key informant interviews will spend 5-30 minutes participating in the study. Willingness to participate in the long-term follow-up study will be assessed by clinic staff/study co-investigators who will complete an informed consent process (waiver of written consent requested) for those interested. The only identifiable information collected will be a participants name and phone number. PHI will be forwarded in encrypted emails to the research team using a secure Children's Healthcare of Atlanta email account and entered into a password protected RedCap database. Survey data will also be collected and stored in that same database. Data confidentiality will be assured by using ID numbers for those who provide identifiable contact information (name and phone number). The code that links identifiers to subjects will be stored on locked and password protected devices, with access only give to study staff who need the information to perform the study.

Interventions

BEHAVIORALEducational Video about SCB

3-4 minutes video about SCB.

BEHAVIORALSurvey on child feeding and related knowledge and practices

Short survey about infant feeding practices (3-4 minutes). No identifying information will be collected. The general scope of topics covered in the surveys will be attitudes toward the sugar-containing beverage reduction (SCB) videos played at the clinic as well as SCB knowledge and practices of parents and their children.

BEHAVIORALEducational Video other than SCB

Educational video about a topic other than infant SCB consumption.

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Emory University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Being over 18 years of age, AND * Being a parent/caregiver of a child age 4-15 months, AND * Attending a well-child visit at the collaborating pediatric primary care clinic and planning to continue during the pilot implementation.

Exclusion criteria

* Parents/caregivers with cognitive or behavioral limitations that preclude completion of the survey * Parents/caregivers of children with conditions that require special feeding protocols, e.g. tube feedings, high calorie supplements * Parent/caregivers who are not able to communicate in English

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Parents Who Are Aware of Infant Fruit Juice Consumption Recommendations0-3 months post-interventionThis 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.
Percentage of Parents Who Report That They do Not Give Their Young Children Fruit Juice2-3 months post-interventionParents will be asked if they give their young child fruit juice. Response options will be yes or no. Participants responding no are reported.
Percentage of Parents Who Report That They do Not Give Their Young Children Sugar-sweetened Beverages.2-3 months post-interventionParents will be asked if they give their young child sugar-sweetened beverages. Response options will be yes or no. Percentage of parents who reportno will be reported.

Secondary

MeasureTime frameDescription
Percentage of Clinic Staff Who Report That the SCB Consumption Related Videos Were Easy to Incorporate Into the Flow of Clinic OperationsUp 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.
Percentage of Parents Who Viewed an Intervention Video Report That They Enjoyed itimmediately post-intervention, within 30 minutesParents 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.
Percentage of Parents Who Viewed an Intervention Video Report That They Learned Something From itimmediately post-intervention, within 30 minutesParents 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Control Group
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).
116
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.
267
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.
0
Total383

Baseline characteristics

CharacteristicIntervention GroupTotalControl Group
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
54 Participants85 Participants31 Participants
Age, Categorical
Between 18 and 65 years
213 Participants298 Participants85 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
9 Participants15 Participants6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
258 Participants368 Participants110 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Number of participants that completed and infant feeding practices survey267 Participants321 Participants54 Participants
Number of participants that viewed and completed survey on perceptions of educational video267 Participants329 Participants62 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
238 Participants343 Participants105 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants3 Participants1 Participants
Race (NIH/OMB)
White
27 Participants37 Participants10 Participants
Region of Enrollment
United States
267 participants383 participants116 participants
Sex: Female, Male
Female
231 Participants335 Participants104 Participants
Sex: Female, Male
Male
36 Participants48 Participants12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1160 / 267
other
Total, other adverse events
0 / 1160 / 267
serious
Total, serious adverse events
0 / 1160 / 267

Outcome results

Primary

Percentage of Parents Who Are Aware of Infant Fruit Juice Consumption Recommendations

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.

Time frame: 0-3 months post-intervention

Population: 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.

ArmMeasureValue (NUMBER)
Control GroupPercentage of Parents Who Are Aware of Infant Fruit Juice Consumption Recommendations19.57 percentage of participants
Intervention GroupPercentage of Parents Who Are Aware of Infant Fruit Juice Consumption Recommendations27.27 percentage of participants
Primary

Percentage of Parents Who Report That They do Not Give Their Young Children Fruit Juice

Parents will be asked if they give their young child fruit juice. Response options will be yes or no. Participants responding no are reported.

Time frame: 2-3 months post-intervention

Population: 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.

ArmMeasureValue (NUMBER)
Control GroupPercentage of Parents Who Report That They do Not Give Their Young Children Fruit Juice58.3 percentage of participants
Intervention GroupPercentage of Parents Who Report That They do Not Give Their Young Children Fruit Juice60.5 percentage of participants
Primary

Percentage of Parents Who Report That They do Not Give Their Young Children Sugar-sweetened Beverages.

Parents will be asked if they give their young child sugar-sweetened beverages. Response options will be yes or no. Percentage of parents who reportno will be reported.

Time frame: 2-3 months post-intervention

Population: 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.

ArmMeasureValue (NUMBER)
Control GroupPercentage of Parents Who Report That They do Not Give Their Young Children Sugar-sweetened Beverages.8.3 percentage of participants
Intervention GroupPercentage of Parents Who Report That They do Not Give Their Young Children Sugar-sweetened Beverages.55.6 percentage of participants
Secondary

Percentage of Clinic Staff Who Report That the SCB Consumption Related Videos Were Easy to Incorporate Into the Flow of Clinic Operations

This 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.

Time frame: Up to 9 months post-intervention

ArmMeasureValue (NUMBER)
Control GroupPercentage of Clinic Staff Who Report That the SCB Consumption Related Videos Were Easy to Incorporate Into the Flow of Clinic Operations80 percentage of participants
Secondary

Percentage of Parents Who Viewed an Intervention Video Report That They Enjoyed it

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.

Time frame: immediately post-intervention, within 30 minutes

Population: The Intervention Group includes participants that viewed a video at their child's 4-month or 12-month visit.

ArmMeasureValue (NUMBER)
Control GroupPercentage of Parents Who Viewed an Intervention Video Report That They Enjoyed it87 percentage of participants
Intervention GroupPercentage of Parents Who Viewed an Intervention Video Report That They Enjoyed it95.9 percentage of participants
Secondary

Percentage of Parents Who Viewed an Intervention Video Report That They Learned Something From it

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.

Time frame: immediately post-intervention, within 30 minutes

Population: 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.

ArmMeasureValue (NUMBER)
Control GroupPercentage of Parents Who Viewed an Intervention Video Report That They Learned Something From it83.9 percentage of participants
Intervention GroupPercentage of Parents Who Viewed an Intervention Video Report That They Learned Something From it95.5 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026