ObesityNCT01296945
Nutrition Knowledge for Spanish-speaking Parents
A study testing Kiosk, paper and Kiosk PLUS paper in people with Obesity and Dental Caries, run by Johns Hopkins University at 1 site in United States.
Trial summary
Providing child nutrition information is a major goal of every pediatric well-child visit. Unfortunately, due to a wide array of issues, doing this effectively during clinic visits is challenging and insufficient. 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?
- Kiosk, paper and Kiosk PLUS paper
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Sep 2011
- 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
- Self identify as Latino/a
- Spanish-speaking
- Over 18 years old
- Primary caregiver to a child 2 years old and under
Who cannot join
- Child 2 years old and under has significant medical issue requiring special nutrition needs, e.g. g-tube or feeding tube dependent, severe food allergies.
- Person has used the nutrition modules before in prior studies
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: Nutrition Knowledge for Spanish-speaking Parents: Evaluation of Paper Handouts, Computer Modules and Web Modules
Providing child nutrition information is a major goal of every pediatric well-child visit. Unfortunately, due to a wide array of issues, doing this effectively during clinic visits is challenging and insufficient. It is because of this that some have looked for innovative ways to enhance the delivery of this information. One such way is the use of touch screen computer programs containing nutritional information. Several studies have documented the value of patients receiving health information in such a manner.
Nonetheless, the use of this medium has not been well studied in Spanish-speaking care providers of young children. The investigators recently conducted a study that evaluated user's perception of the usability of such technology, finding that most users thought that the touchscreen was easy to use, despite their low computer confidence levels. The investigators also evaluated the impact of using nutrition modules on user's nutrition knowledge, finding that immediately after use; participant's nutrition knowledge was improved. I now propose to evaluate this technology further through a 4 armed randomized controlled trial. The goal here is to evaluate the longer term impact of the educational modules on nutrition knowledge and the impact, if any, of additional web access to the modules, on longer term knowledge. A secondary goal is to better understand nutritional habits in this population and perceptions of weight.
- Conditions
- Obesity, Dental Caries
- Being tested
- Kiosk, paper, Kiosk PLUS paper, Kiosk PLUS web
- 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.
KioskOther
Touchscreen computer containing three educational modules in Spanish on infant/toddler juice intake, milk, and solid/foods
paperOther
Participants will receive a paper handout with nutrition educational information.
Kiosk PLUS paperOther
Individuals will use the 3 computer modules on a touchscreen and receive the information on a paper handout.
Kiosk PLUS webOther
Participants will utilize the 3 modules on the touchscreen computer and be given a piece of paper that includes information on how to see this information again on the internet. Participants will be asked to view the modules on the web.
| Study group | Role | What they receive |
|---|---|---|
| Kiosk | Active comparator | Not described Receives: Other: Kiosk |
| Paper | Active comparator | Not described Receives: Other: paper |
| Kiosk PLUS paper | Active comparator | Not described Receives: Other: Kiosk PLUS paper |
| kiosk PLUS web | Active comparator | Not described Receives: Other: Kiosk PLUS web |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge score
Knowledge score on the nutrition survey will be compared across groups at this time point.
Measured: Day 14
Secondary outcomes (2)
knowledge score
Knowledge score on the nutrition survey will be compared between the paper group and the kiosk group.
Measured: Day 1
Knowledge score
Knowledge score on the nutrition survey will be compared across groups at this time point - 2 months.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionSep 2011
- Study completionSep 2011
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 Johns Hopkins UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darcy Thompson, Johns Hopkins University
- Investigators
- Darcy A Thompaon, MD, MPH, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296945
- Sponsor's protocol ID
- NA_00045360
- Status last verified
- Mar 2012
- First submitted
- 15 Feb 2011
- Last updated
- 30 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Knowledge for Spanish-speaking Parents: Evaluation of Paper Handouts, Computer Modules and Web Modules
- ClinicalTrials.gov ID
- NCT01296945
- Acronym / sponsor ID
- NA_00045360
- Conditions
- Obesity, Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 16 Feb 2011 (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.
Providing child nutrition information is a major goal of every pediatric well-child visit. Unfortunately, due to a wide array of issues, doing this effectively during clinic visits is challenging and insufficient. It is because of this that some have looked for innovative ways to enhance the delivery of this information. One such way is the use of touch screen computer programs containing nutritional information. Several studies have documented the value of patients receiving health information in such a manner.
Nonetheless, the use of this medium has not been well studied in Spanish-speaking care providers of young children. The investigators recently conducted a study that evaluated user's perception of the usability of such technology, finding that most users thought that the touchscreen was easy to use, despite their low computer confidence levels. The investigators also evaluated the impact of using nutrition modules on user's nutrition knowledge, finding that immediately after use; participant's nutrition knowledge was improved. I now propose to evaluate this technology further through a 4 armed randomized controlled trial. The goal here is to evaluate the longer term impact of the educational modules on nutrition knowledge and the impact, if any, of additional web access to the modules, on longer term knowledge. A secondary goal is to better understand nutritional habits in this population and perceptions of weight.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Kiosk | Active comparator | Other: Kiosk |
| Paper | Active comparator | Other: paper |
| Kiosk PLUS paper | Active comparator | Other: Kiosk PLUS paper |
| kiosk PLUS web | Active comparator | Other: Kiosk PLUS web |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Self identify as Latino/a
- Spanish-speaking
- Over 18 years old
- Primary caregiver to a child 2 years old and under
Key exclusion criteria (2 listed)
- Child 2 years old and under has significant medical issue requiring special nutrition needs, e.g. g-tube or feeding tube dependent, severe food allergies.
- Person has used the nutrition modules before in prior studies
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 |
|---|---|---|
| KioskTouchscreen computer containing three educational modules in Spanish on infant/toddler juice intake, milk, and solid/foods | Other | Kiosk |
| paperParticipants will receive a paper handout with nutrition educational information. | Other | Paper |
| Kiosk PLUS paperIndividuals will use the 3 computer modules on a touchscreen and receive the information on a paper handout. | Other | Kiosk PLUS paper |
| Kiosk PLUS webParticipants will utilize the 3 modules on the touchscreen computer and be given a piece of paper that includes information on how to see this information again on the internet. Participants will be asked to view the modules on the web. | Other | kiosk PLUS web |
Primary outcome
Knowledge score
Time frame: Day 14
Knowledge score on the nutrition survey will be compared across groups at this time point.
2 secondary outcomes
knowledge score
Time frame: Day 1
Knowledge score
Time frame: 2 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 30 Mar 2012.
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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.
Darcy A Thompaon, MD, MPH principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kiosk, paper and Kiosk PLUS paper in people with Obesity and Dental Caries, run by Johns Hopkins University 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 4 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 30 Mar 2012. 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?
Knowledge score (time frame: Day 14). 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 30 Mar 2012; AzTrials last refreshed its copy on 1 Nov 2026.