Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-26 @ 4:53 AM
Study NCT ID:
NCT05011292
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2021-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Well-child Visit Video Project
Sponsor:
Emory University
Organization:
Study Overview
Official Title:
Strengthening and Supporting the Diabetes Early Prevention Efforts of Pediatric Primary Healthcare Providers
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30DK111024 | NIH | None | https://reporter.nih.gov/quic… | View |