NCT02257203

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2014

Completed
7 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 20, 2016

Status Verified

September 1, 2016

Enrollment Period

1.2 years

First QC Date

September 24, 2014

Last Update Submit

September 16, 2016

Conditions

ObesityDental Caries

Keywords

Dietary sucrose

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (4)

  • Servings of SSB and 100% fruit juice in the past 7 days

    Baseline

  • Servings of SSB and 100% fruit juice in the past 7 days

    2 weeks

  • Servings of SSB and 100% fruit juice in the past 7 days

    2 months

  • Servings of SSB and 100% fruit juice in the past 7 days

    3 months

Study Arms (2)

Sugar Sweetened Beverage Education

EXPERIMENTAL

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

Reading Education

ACTIVE COMPARATOR

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

Interventions

Sugar Sweetened Beverage EducationBEHAVIORAL

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

Sugar Sweetened Beverage Education
Reading EducationBEHAVIORAL

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

Reading Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Health Center at San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

ObesityDental Caries

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsTooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Amy L Beck, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2014

First Posted

October 6, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 20, 2016

Record last verified: 2016-09

Locations

US(1)