ObesityNCT02257203
Primary Care Beverage Study
A study testing Sugar Sweetened Beverage Education and Reading Education in people with Obesity and Dental Caries, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Dental Caries
- What is being tested?
- Sugar Sweetened Beverage Education and Reading Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents self-identify as Latino
- Parents speak English or Spanish
- Parents have a child between the ages of 6 months and 5 years
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Health Center at San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: Evaluation of a Primary Care-Based Intervention to Reduce Consumption of Sugar-sweetened Beverages and 100% Fruit Juice Among Latino Children
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.
Read the 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.
- Conditions
- Obesity, Dental Caries
- Being tested
- Sugar Sweetened Beverage Education, Reading Education
- Keywords
- Dietary sucrose
- Medical subject headings
- Obesity, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar Sweetened Beverage EducationBehavioural
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 EducationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Reading Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)
24-hour recall
Measured: Baseline
Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)
24-hour recall
Measured: 2 weeks
Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)
24-hour recall
Measured: 2 months
Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)
24-hour recall
Measured: 3 months
Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines
24-hour recall
Measured: Baseline
Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines
24-hour recall
Measured: 2 weeks
Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines
24-hour recall
Measured: 2 months
Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines
24-hour recall
Measured: 3 months
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Pediatric Association
- Responsible party
- Sponsor
- Investigators
- Amy L Beck, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02257203
- Sponsor's protocol ID
- PC-Based Beverage
- Status last verified
- Sep 2016
- First submitted
- 24 Sep 2014
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Primary Care-Based Intervention to Reduce Consumption of Sugar-sweetened Beverages and 100% Fruit Juice Among Latino Children
- ClinicalTrials.gov ID
- NCT02257203
- Acronym / sponsor ID
- PC-Based Beverage
- Conditions
- Obesity, Dental Caries
- Keywords
- Dietary sucrose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Academic Pediatric Association
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar Sweetened Beverage Education | Experimental | Behavioral: Sugar Sweetened Beverage EducationParents 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 | Active comparator | Behavioral: Reading EducationParents 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parents self-identify as Latino
- Parents speak English or Spanish
- Parents have a child between the ages of 6 months and 5 years
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sugar Sweetened Beverage EducationParents 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 | Behavioural | Sugar Sweetened Beverage Education |
| Reading EducationParents 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 | Behavioural | Reading Education |
Primary outcome
Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)
Time frame: Baseline
24-hour recall
Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)
Time frame: 2 weeks
24-hour recall
Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)
Time frame: 2 months
24-hour recall
Number of participants reporting child's consumption of sugar-sweetened beverages (SSB)
Time frame: 3 months
24-hour recall
Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines
Time frame: Baseline
24-hour recall
Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines
Time frame: 2 weeks
24-hour recall
Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines
Time frame: 2 months
24-hour recall
Number of participants reporting child's consumption of 100% fruit juice in excess of guidelines
Time frame: 3 months
24-hour recall
4 secondary outcomes
Servings of SSB and 100% fruit juice in the past 7 days
Time frame: Baseline
Servings of SSB and 100% fruit juice in the past 7 days
Time frame: 2 weeks
Servings of SSB and 100% fruit juice in the past 7 days
Time frame: 2 months
Servings of SSB and 100% fruit juice in the past 7 days
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy L Beck, MD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugar Sweetened Beverage Education and Reading Education in people with Obesity and Dental Caries, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants reporting child's consumption of sugar-sweetened beverages (SSB) (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2016.