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Completed

NCT Number: NCT02257203

Primary Care Beverage Study

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.

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Key information

Conditions

Obesity Body Weight Dental Caries Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Health Center at San Francisco General Hospital

San Francisco, California, 94110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sugar Sweetened Beverage Education

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

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

Primary outcomes

  1. Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)

    Time frame: Baseline

    24-hour recall

  2. Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)

    Time frame: 2 weeks

    24-hour recall

  3. Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)

    Time frame: 2 months

    24-hour recall

  4. Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)

    Time frame: 3 months

    24-hour recall

  5. Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines

    Time frame: Baseline

    24-hour recall

  6. Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines

    Time frame: 2 weeks

    24-hour recall

  7. Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines

    Time frame: 2 months

    24-hour recall

  8. Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines

    Time frame: 3 months

    24-hour recall

Secondary outcomes

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

    Time frame: Baseline

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

    Time frame: 2 weeks

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

    Time frame: 2 months

    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

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

    Time frame: 3 months

    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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Academic Pediatric Association

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 6, 2014
Registry last updated
Sep 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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