Reduction of Excessive Calories From Beverages in Children (MWP)

Randomized Controlled Trial to Reduce Calorie Intake From Sugar-sweetened Beverages by Children 1 - 12 Years of Age

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.

Study Overview

• Status: Completed
• Conditions: Unhealthy Diet
• Intervention / Treatment: Behavioral: Physician communication

Detailed Description

The study will be conducted through a practice-based research network of community pediatric practices. Participating sites will be randomized to the intervention or control condition (usual care) using a pre-specified randomization scheme derived using computer generated random numbers. The intervention sites will participate in a 30-minute training for using the "Milk. Water. Period" intervention (brochures, posters, key talking points and phone messages) in their office. The goal is for them to discuss beverage consumption and encourage "Milk. Water. Period" for all children 12 months to 12 years old (not yet reached their 13th birthday) at their checkup visit. The primary care provider (PCP) will use the talking points to facilitate the discussion about drink milk and water only and will give a brochure to each family. Assessments will be by telephone interview of the parent 2 to 4 weeks after a check-up visit for the index child.

• Study Type: Interventional
• Enrollment (Actual): 443
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care
Experimental: Physician communication; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): November 21, 2014
• Study Completion (Actual): November 21, 2014

Study Registration Dates

• First Submitted: September 10, 2014
• First Submitted That Met QC Criteria: September 10, 2014
• First Posted (Estimate): September 15, 2014

Study Record Updates

• Last Update Posted (Actual): October 2, 2018
• Last Update Submitted That Met QC Criteria: October 1, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 201403027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No