Back to resultsPrimary Care Beverage Study
Primary Purpose
Obesity, Dental Caries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sugar Sweetened Beverage Education
Reading Education
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Dietary sucrose
Eligibility Criteria
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)
Sites / Locations
- Children's Health Center at San Francisco General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sugar Sweetened Beverage Education
Reading Education
Arm Description
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
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
Outcomes
Primary Outcome Measures
Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)
24-hour recall
Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)
24-hour recall
Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)
24-hour recall
Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)
24-hour recall
Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines
24-hour recall
Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines
24-hour recall
Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines
24-hour recall
Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines
24-hour recall
Secondary Outcome Measures
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
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
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
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
Full Information
NCT ID
NCT02257203
First Posted
September 24, 2014
Last Updated
September 16, 2016
Sponsor
University of California, San Francisco
Collaborators
Academic Pediatric Association
1. Study Identification
Unique Protocol Identification Number
NCT02257203
Brief Title
Primary Care Beverage Study
Official Title
Evaluation of a Primary Care-Based Intervention to Reduce Consumption of Sugar-sweetened Beverages and 100% Fruit Juice Among Latino Children
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Academic Pediatric Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Dental Caries
Keywords
Dietary sucrose
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sugar Sweetened Beverage Education
Arm Type
Experimental
Arm Description
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
Arm Title
Reading Education
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Sugar Sweetened Beverage Education
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Reading Education
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)
Description
24-hour recall
Time Frame
Baseline
Title
Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)
Description
24-hour recall
Time Frame
2 weeks
Title
Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)
Description
24-hour recall
Time Frame
2 months
Title
Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)
Description
24-hour recall
Time Frame
3 months
Title
Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines
Description
24-hour recall
Time Frame
Baseline
Title
Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines
Description
24-hour recall
Time Frame
2 weeks
Title
Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines
Description
24-hour recall
Time Frame
2 months
Title
Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines
Description
24-hour recall
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Servings of SSB and 100% fruit juice in the past 7 days
Description
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
Time Frame
Baseline
Title
Servings of SSB and 100% fruit juice in the past 7 days
Description
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
Time Frame
2 weeks
Title
Servings of SSB and 100% fruit juice in the past 7 days
Description
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
Time Frame
2 months
Title
Servings of SSB and 100% fruit juice in the past 7 days
Description
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
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy L Beck, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Health Center at San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Primary Care Beverage Study
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