Primary Care Beverage Study

Study Overview
=================
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.

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

Conditions
-----------------
Obesity, Dental Caries

Intervention / Treatment
-----------------
* Behavioral: Sugar Sweetened Beverage Education
* Behavioral: Reading Education


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sugar Sweetened Beverage Education<br>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<br>* 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<br>|
| Active Comparator: Reading Education<br>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<br>* 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<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dietary sucrose