Primary Care Beverage Study

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02257203
• Other study ID #: PC-Based Beverage
• Status: Completed
• Phase: N/A
• First received: September 24, 2014
• Last updated: September 16, 2016
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: September 2016
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries
• Obesity

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Children's Health Center at San Francisco General Hospital	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Academic Pediatric Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)	24-hour recall	Baseline	No
Primary	Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)	24-hour recall	2 weeks	No
Primary	Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)	24-hour recall	2 months	No
Primary	Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)	24-hour recall	3 months	No
Primary	Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines	24-hour recall	Baseline	No
Primary	Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines	24-hour recall	2 weeks	No
Primary	Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines	24-hour recall	2 months	No
Primary	Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines	24-hour recall	3 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No