NCT05011292

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
388

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 20, 2024

Completed
Last Updated

June 20, 2024

Status Verified

June 1, 2024

Enrollment Period

1.7 years

First QC Date

August 13, 2021

Results QC Date

April 30, 2024

Last Update Submit

June 11, 2024

Conditions

Keywords

PreventionType 2 Diabetes

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Percentage of Clinic Staff Who Report That the SCB Consumption Related Videos Were Easy to Incorporate Into the Flow of Clinic Operations

    Up to 9 months post-intervention

  • Percentage of Parents Who Viewed an Intervention Video Report That They Enjoyed it

    immediately post-intervention, within 30 minutes

  • Percentage of Parents Who Viewed an Intervention Video Report That They Learned Something From it

    immediately post-intervention, within 30 minutes

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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 practicesBehavioral: 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).

Behavioral: Educational Video about SCBBehavioral: Survey on child feeding and related knowledge and practices

Interventions

3-4 minutes video about SCB.

Intervention Group

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.

Control GroupIntervention Group

Educational video about a topic other than infant SCB consumption.

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta - Hughes Spalding Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Dr. Jean Welsh
Organization
Emory University

Study Officials

  • Jean Welsh, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 13, 2021

First Posted

August 18, 2021

Study Start

August 10, 2021

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

June 20, 2024

Results First Posted

June 20, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations