Type 2 DiabetesNCT05011292
Well-child Visit Video Project
A study testing Educational Video about SCB, Survey on child feeding and related knowledge and practices and Educational Video other than SCB in people with Type 2 Diabetes, run by Emory University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Educational Video about SCB, Survey on child feeding and related knowledge and practices and Educational Video other than SCB
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2021to 1 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta - Hughes Spalding Hospital
Atlanta, Georgia, 30303
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Educational Video about SCB, Survey on child feeding and related knowledge and practices, Educational Video other than SCB
- Keywords
- Prevention, Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Video about SCBBehavioural
3-4 minutes video about SCB.
Survey on child feeding and related knowledge and practicesBehavioural
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 SCBBehavioural
Educational video about a topic other than infant SCB consumption.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | The control group includes parents that will view an educational video about a topic other than infant SCB consumption. Receives: Behavioral: Survey on child feeding and related knowledge and practices; Behavioral: Educational Video other than SCB |
| Intervention Group | Experimental | 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). Receives: Behavioral: Educational Video about SCB; Behavioral: Survey on child feeding and related knowledge and practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2-3 months post-intervention
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: immediately post-intervention, within 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start10 Aug 2021
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Welsh, Emory University
- Investigators
- Jean Welsh, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011292
- Sponsor's protocol ID
- STUDY00001393
- Other IDs
- P30DK111024
- Status last verified
- Jun 2024
- First submitted
- 13 Aug 2021
- Last updated
- 20 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Welsh JA, Chiang KV, Rivell A, Livingston-Burns B, McFadden T. Use of Videos to Provide Anticipatory Infant Feeding Guidance During Well-Child Visits: A Pragmatic Pilot Study. Clin Pediatr (Phila). 2026 May;65(4):574-583. doi: 10.1177/00099228251408938. Epub 2026 Jan 7.
PubMed 41499235
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening and Supporting the Diabetes Early Prevention Efforts of Pediatric Primary Healthcare Providers
- ClinicalTrials.gov ID
- NCT05011292
- Acronym / sponsor ID
- STUDY00001393
- Conditions
- Type 2 Diabetes
- Keywords
- Prevention, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Posted 20 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Survey on child feeding and related knowledge and practices, Behavioral: Educational Video other than SCBThe control group includes parents that will view an educational video about a topic other than infant SCB consumption. |
| Intervention Group | Experimental | Behavioral: Educational Video about SCB, Behavioral: Survey on child feeding and related knowledge and practicesThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Video about SCB3-4 minutes video about SCB. | Behavioural | Intervention Group |
| Survey on child feeding and related knowledge and practicesShort 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. | Behavioural | Control Group, Intervention Group |
| Educational Video other than SCBEducational video about a topic other than infant SCB consumption. | Behavioural | Control Group |
Primary outcome
Percentage of Parents Who Are Aware of Infant Fruit Juice Consumption Recommendations
Time frame: 0-3 months post-intervention
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.
Percentage of Parents Who Report That They do Not Give Their Young Children Fruit Juice
Time frame: 2-3 months post-intervention
Parents will be asked if they give their young child fruit juice. Response options will be "yes" or "no". Participants responding "no" are reported.
Percentage of Parents Who Report That They do Not Give Their Young Children Sugar-sweetened Beverages.
Time frame: 2-3 months post-intervention
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.
3 secondary outcomes
Percentage of Clinic Staff Who Report That the SCB Consumption Related Videos Were Easy to Incorporate Into the Flow of Clinic Operations
Time frame: Up to 9 months post-intervention
Percentage of Parents Who Viewed an Intervention Video Report That They Enjoyed it
Time frame: immediately post-intervention, within 30 minutes
Percentage of Parents Who Viewed an Intervention Video Report That They Learned Something From it
Time frame: immediately post-intervention, within 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41499235Welsh JA, Chiang KV, Rivell A, Livingston-Burns B, McFadden T. Use of Videos to Provide Anticipatory Infant Feeding Guidance During Well-Child Visits: A Pragmatic Pilot Study. Clin Pediatr (Phila). 2026 May;65(4):574-583. doi: 10.1177/00099228251408938. Epub 2026 Jan 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Welsh, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Video about SCB, Survey on child feeding and related knowledge and practices and Educational Video other than SCB in people with Type 2 Diabetes, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Parents Who Are Aware of Infant Fruit Juice Consumption Recommendations (time frame: 0-3 months post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05011292, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024; AzTrials last refreshed its copy on 27 Oct 2026.