Primary Care Beverage Study

NCT ID: NCT02257203

Last Updated: 2016-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Dental Caries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Sugar Sweetened Beverage Education

Intervention Type BEHAVIORAL

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 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

Group Type ACTIVE_COMPARATOR

Reading Education

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Academic Pediatric Association

INDUSTRY

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amy L Beck, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's Health Center at San Francisco General Hospital

San Francisco, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PC-Based Beverage

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Filipino Family Health Initiative
NCT04031170 ACTIVE_NOT_RECRUITING NA
Prevention of NAFLD in Hispanic Children
NCT05292352 ACTIVE_NOT_RECRUITING NA
Prevention of Childhood Obesity
NCT00788203 COMPLETED