Primary Care Beverage Study

Evaluation of a Primary Care-Based Intervention to Reduce Consumption of Sugar-sweetened Beverages and 100% Fruit Juice Among Latino Children

This is a pilot randomized clinical trial of a brief educational intervention offered in primary care for Latino parents that promotes healthy beverage consumption by infants and toddlers. The control group will receive an educational intervention that promotes parents reading to children.

Study Overview

• Status: Completed
• Conditions: Obesity; Dental Caries
• Intervention / Treatment: Behavioral: Sugar Sweetened Beverage Education; Behavioral: Reading Education

Detailed Description

To use a randomized controlled trial (RCT) design to test the efficacy of a primary care-based intervention to promote Bright Futures recommendations for consumption of sugar-sweetened beverages and 100% fruit juice among Latino children ages 6 months to 5 years.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Children's Health Center at San Francisco General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Parents self-identify as Latino
• Parents speak English or Spanish
• Parents have a child between the ages of 6 months and 5 years

Exclusion Criteria:

• Parents who have participated in group educational sessions on nutrition offered through our obesity clinic or who have been newly referred to obesity clinic
• Parents whose child has a chronic condition which affects feeding (such as requiring tube feeds or being on a specialized diet for poor weight gain)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sugar Sweetened Beverage Education; Parents will receive an educational module on beverage just after the conclusion of their child's well visit in a private room adjacent to the clinic	Behavioral: Sugar Sweetened Beverage Education; Parents will receive an educational module on beverage just after the conclusion of their child's well visit in a private room adjacent to the clinic
Active Comparator: Reading Education; Parents will receive an educational module on the importance of reading to children with instruction in interactive reading techniques that are appropriate to the child's age	Behavioral: Reading Education; Parents randomized to control will receive a 25-minute educational module on the importance of reading to children with instruction in interactive reading techniques that are appropriate to the child's age

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)	24-hour recall	Baseline
Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)	24-hour recall	2 weeks
Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)	24-hour recall	2 months
Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)	24-hour recall	3 months
Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines	24-hour recall	Baseline
Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines	24-hour recall	2 weeks
Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines	24-hour recall	2 months
Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines	24-hour recall	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Servings of SSB and 100% fruit juice in the past 7 days	From the 7-day structured beverage frequency questionnaire we will determine the total servings of SSBs and 100% fruit juice consumed over a 7-day period at each time point	Baseline
Servings of SSB and 100% fruit juice in the past 7 days	From the 7-day structured beverage frequency questionnaire we will determine the total servings of SSBs and 100% fruit juice consumed over a 7-day period at each time point	2 weeks
Servings of SSB and 100% fruit juice in the past 7 days	From the 7-day structured beverage frequency questionnaire we will determine the total servings of SSBs and 100% fruit juice consumed over a 7-day period at each time point	2 months
Servings of SSB and 100% fruit juice in the past 7 days	From the 7-day structured beverage frequency questionnaire we will determine the total servings of SSBs and 100% fruit juice consumed over a 7-day period at each time point	3 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Academic Pediatric Association
• Investigators: Principal Investigator: Amy L Beck, MD, MPH, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: September 24, 2014
• First Submitted That Met QC Criteria: October 3, 2014
• First Posted (Estimate): October 6, 2014

Study Record Updates

• Last Update Posted (Estimate): September 20, 2016
• Last Update Submitted That Met QC Criteria: September 16, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Dietary sucrose
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: PC-Based Beverage