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Well-child Visit Video Project

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Video about SCB
Survey on child feeding and related knowledge and practices
Educational Video other than SCB
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring Prevention, Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Healthcare of Atlanta - Hughes Spalding Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Intervention Group

Arm Description

The control group includes parents that will view an educational video about a topic other than infant SCB consumption.

The intervention group will include those parents who participate in the study after the control data has been collected and two SCB reduction-related videos have been introduced (one for showing at the 4-month visit and one for the 12-month visit).

Outcomes

Primary Outcome Measures

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. Higher knowledge correlates with better outcome.
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".

Secondary Outcome Measures

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". Responses will be on a 5-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree". Higher score correlates with better outcome.
Percentage of parents who viewed an intervention video report that they enjoyed it or learned something from it
Parents will be asked specifically if they "enjoyed the video" and if the "learned something" from it. Responses will be on a 5-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree". Higher score correlates with better outcome.

Full Information

First Posted
August 13, 2021
Last Updated
June 30, 2023
Sponsor
Emory University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05011292
Brief Title
Well-child Visit Video Project
Official Title
Strengthening and Supporting the Diabetes Early Prevention Efforts of Pediatric Primary Healthcare Providers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 10, 2021 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
May 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Parents of children attending a 4, 6, 9, 12 or 15-month well-child visit (Main study) 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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Prevention, Type 2 Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
677 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The control group includes parents that will view an educational video about a topic other than infant SCB consumption.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The intervention group will include those parents who participate in the study after the control data has been collected and two SCB reduction-related videos have been introduced (one for showing at the 4-month visit and one for the 12-month visit).
Intervention Type
Behavioral
Intervention Name(s)
Educational Video about SCB
Intervention Description
3-4 minutes video about SCB.
Intervention Type
Behavioral
Intervention Name(s)
Survey on child feeding and related knowledge and practices
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Educational Video other than SCB
Intervention Description
Educational video about a topic other than infant SCB consumption.
Primary Outcome Measure Information:
Title
Percentage of parents who are aware of infant fruit juice consumption recommendations
Description
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. Higher knowledge correlates with better outcome.
Time Frame
Up to 5 months post-intervention
Title
Percentage of parents who report that they do not give their young children fruit juice
Description
Parents will be asked if they give their young child fruit juice. Response options will be "yes" or "no".
Time Frame
Up to 5 months post-intervention
Secondary Outcome Measure Information:
Title
Percentage of clinic staff who report that the SCB consumption related videos were easy to incorporate into the flow of clinic operations
Description
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". Responses will be on a 5-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree". Higher score correlates with better outcome.
Time Frame
Up to 5 months post-intervention
Title
Percentage of parents who viewed an intervention video report that they enjoyed it or learned something from it
Description
Parents will be asked specifically if they "enjoyed the video" and if the "learned something" from it. Responses will be on a 5-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree". Higher score correlates with better outcome.
Time Frame
Up to 5 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Welsh, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Healthcare of Atlanta - Hughes Spalding Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Well-child Visit Video Project

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