An interventional study of Educational Video about SCB and Survey on child feeding and related knowledge and practices in Type 2 Diabetes, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-20.
Sponsored by Emory University · Not applicable, Interventional, and Prevention
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 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:
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 388 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Behavioral: Educational Video other than SCB
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: Educational Video about SCB · Behavioral: Survey on child feeding and related knowledge and practices
3-4 minutes video about SCB.
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 about a topic other than infant SCB consumption.
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.
Time frame: 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.
Time frame: 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.
Time frame: 2-3 months post-intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: immediately post-intervention, within 30 minutes
| Milestone | Control Group | Intervention Group | Clinical Staff |
|---|---|---|---|
| Started | 116 | 267 | 5 |
| Completed | 116 | 56 | 5 |
| Not completed | 0 | 211 | 0 |
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 participants | Control Group | Intervention Group |
|---|---|---|
| Percentage of Parents Who Are Aware of Infant Fruit Juice Consumption Recommendations | 19.57 | 27.27 |
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 participants | Control Group | Intervention Group |
|---|---|---|
| Percentage of Parents Who Report That They do Not Give Their Young Children Fruit Juice | 58.3 | 60.5 |
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.
| percentage of participants | Control Group | Intervention Group |
|---|---|---|
| Percentage of Parents Who Report That They do Not Give Their Young Children Sugar-sweetened Beverages. | 8.3 | 55.6 |
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.
| percentage of participants | Clinical Staff |
|---|---|
| Percentage of Clinic Staff Who Report That the SCB Consumption Related Videos Were Easy to Incorporate Into the Flow of Clinic Operations | 80 |
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.
| percentage of participants | Control Group | Intervention Group |
|---|---|---|
| Percentage of Parents Who Viewed an Intervention Video Report That They Enjoyed it | 87 | 95.9 |
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.
| percentage of participants | Control Group | Intervention Group |
|---|---|---|
| Percentage of Parents Who Viewed an Intervention Video Report That They Learned Something From it | 83.9 | 95.5 |
Collected over During follow up time (up to 12 months post intervention).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | 0/116 (0%) | 0/116 (0%) | 0/116 (0%) |
| Intervention Group | 0/267 (0%) | 0/267 (0%) | 0/267 (0%) |
Data was not collected for the Clinical Staff group.
| Age, Categorical(Participants) | Control Group | Intervention Group | Clinical Staff | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | — | 0 |
| Between 18 and 65 years | 85 | 213 | — | 298 |
| >=65 years | 31 | 54 | — | 85 |
| Sex: Female, Male(Participants) | Control Group | Intervention Group | Clinical Staff | Total |
|---|---|---|---|---|
| Female | 104 | 231 | — | 335 |
| Male | 12 | 36 | — | 48 |
| Ethnicity (NIH/OMB)(Participants) | Control Group | Intervention Group | Clinical Staff | Total |
|---|---|---|---|---|
| Hispanic or Latino | 6 | 9 | — | 15 |
| Not Hispanic or Latino | 110 | 258 | — | 368 |
| Unknown or Not Reported | 0 | 0 | — | 0 |
| Race (NIH/OMB)(Participants) | Control Group | Intervention Group | Clinical Staff | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | — | 0 |
| Asian | 0 | 0 | — | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | — | 0 |
| Black or African American | 105 | 238 | — | 343 |
| White | 10 | 27 | — | 37 |
| More than one race | 0 | 0 | — | 0 |
| Unknown or Not Reported | 1 | 2 | — | 3 |
| Region of Enrollment(participants) | Control Group | Intervention Group | Clinical Staff | Total |
|---|---|---|---|---|
| United States | 116 | 267 | — | 383 |
| Number of participants that viewed and completed survey on perceptions of educational video(Participants) | Control Group | Intervention Group | Clinical Staff | Total |
|---|---|---|---|---|
| Count of participants | 62 | 267 | — | 329 |
| Number of participants that completed and infant feeding practices survey(Participants) | Control Group | Intervention Group | Clinical Staff | Total |
|---|---|---|---|---|
| Count of participants | 54 | 267 | — | 321 |
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