Well-child Visit Video Project

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05011292
• Other study ID #: STUDY00001393
• Secondary ID: P30DK111024
• Status: Completed
• Phase: N/A
• Start date: August 10, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: June 2024
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 388
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Educational Video about SCB
3-4 minutes video about SCB.
• Survey 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.
• Educational Video other than SCB
Educational video about a topic other than infant SCB consumption.

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta - Hughes Spalding Hospital	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	0-3 months post-intervention
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.	2-3 months post-intervention
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 report"no" will be reported.	2-3 months post-intervention
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.	Up to 9 months post-intervention
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.	immediately post-intervention, within 30 minutes
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.	immediately post-intervention, within 30 minutes