Study Results
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View full resultsBasic Information
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COMPLETED
NA
388 participants
INTERVENTIONAL
2021-08-10
2023-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Control Group
The control group includes parents that will view an educational video about a topic other than infant SCB consumption.
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.
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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Emory University
OTHER
Responsible Party
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Jean Welsh
Associate Professor
Principal Investigators
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Jean Welsh, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Children's Healthcare of Atlanta - Hughes Spalding Hospital
Atlanta, Georgia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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STUDY00001393
Identifier Type: -
Identifier Source: org_study_id
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