NCT02239653

Brief Summary

Objective: to test the hypothesis that an intervention comprised of targeted physician and print messages can influence parents to reduce the amount of sugar-sweetened beverages (SSB) and fruit juice they give to their children 1 - 12 years of age.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
443

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable

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

June 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2014

Completed
Last Updated

October 2, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

September 10, 2014

Last Update Submit

October 1, 2018

Conditions

Unhealthy Diet

Outcome Measures

Primary Outcomes (1)

  • Excessive calories from beverages

    percent of children consuming \>200 calories/day from soda, SSBs, and fruit juice beverages

    2-4 weeks after check-up visit

Study Arms (2)

Physician communication

EXPERIMENTAL

The "Milk. Water. Period" intervention comprises brochures, posters, and key talking points for use by primary pediatricians to use in discussion with the parent about the child's beverages consumption.

Behavioral: Physician communication

Usual care

NO INTERVENTION

Interventions

Physician communicationBEHAVIORAL
Physician communication

Eligibility Criteria

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

You may qualify if:

  • Parent of child age 12 months to 12 years attending for a check-up visit during the study period

You may not qualify if:

  • Cannot speak English
  • No phone access
  • Already completed the survey for another child.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2014

First Posted

September 15, 2014

Study Start

June 1, 2014

Primary Completion

November 21, 2014

Study Completion

November 21, 2014

Last Updated

October 2, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)