Well-child Visit Video Project

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Survey on child feeding and related knowledge and practices; Behavioral: Educational Video other than SCB; Behavioral: Educational Video about SCB

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.

• Study Type: Interventional
• Enrollment (Actual): 388
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Children's Healthcare of Atlanta - Hughes Spalding Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; The control group includes parents that will view an educational video about a topic other than infant SCB consumption.	Behavioral: 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.; Behavioral: Educational Video other than SCB; Educational video about a topic other than infant SCB consumption.
Experimental: Intervention Group; 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).	Behavioral: 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.; Behavioral: Educational Video about SCB; 3-4 minutes video about SCB.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Jean Welsh, PhD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2021
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Prevention
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: STUDY00001393; P30DK111024 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No