Unhealthy DietMWPNCT02239653
Reduction of Excessive Calories From Beverages in Children
A study testing Physician communication in people with Unhealthy Diet, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Objective: to test the hypothesis that an intervention comprised of targeted physician and print messages can influence parents to reduce the amount of sugar-sweetened beverages (SSB) and fruit juice they give to their children 1 - 12 years of age. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unhealthy Diet
- What is being tested?
- Physician communication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 443 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 21 Nov 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parent of child age 12 months to 12 years attending for a check-up visit during the study period
Who cannot join
- Cannot speak English
- No phone access
- Already completed the survey for another child.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Randomized Controlled Trial to Reduce Calorie Intake From Sugar-sweetened Beverages by Children 1 - 12 Years of Age
Objective: to test the hypothesis that an intervention comprised of targeted physician and print messages can influence parents to reduce the amount of sugar-sweetened beverages (SSB) and fruit juice they give to their children 1 - 12 years of age.
Read the detailed description
The study will be conducted through a practice-based research network of community pediatric practices. Participating sites will be randomized to the intervention or control condition (usual care) using a pre-specified randomization scheme derived using computer generated random numbers. The intervention sites will participate in a 30-minute training for using the "Milk. Water. Period" intervention (brochures, posters, key talking points and phone messages) in their office. The goal is for them to discuss beverage consumption and encourage "Milk. Water. Period" for all children 12 months to 12 years old (not yet reached their 13th birthday) at their checkup visit. The primary care provider (PCP) will use the talking points to facilitate the discussion about drink milk and water only and will give a brochure to each family. Assessments will be by telephone interview of the parent 2 to 4 weeks after a check-up visit for the index child.
- Conditions
- Unhealthy Diet
- Being tested
- Physician communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician communicationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Physician communication | Experimental | The "Milk. Water. Period" intervention comprises brochures, posters, and key talking points for use by primary pediatricians to use in discussion with the parent about the child's beverages consumption. Receives: Behavioral: Physician communication |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excessive calories from beverages
percent of children consuming >200 calories/day from soda, SSBs, and fruit juice beverages
Measured: 2-4 weeks after check-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startJun 2014
- Primary completion21 Nov 2014
- Study completion21 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unhealthy DietStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239653
- Sponsor's protocol ID
- 201403027
- Acronym
- MWP
- Status last verified
- Oct 2018
- First submitted
- 10 Sep 2014
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Reduce Calorie Intake From Sugar-sweetened Beverages by Children 1 - 12 Years of Age
- ClinicalTrials.gov ID
- NCT02239653
- Acronym / sponsor ID
- MWP / 201403027
- Conditions
- Unhealthy Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- 21 Nov 2014 (actual)
- Study completion
- 21 Nov 2014 (actual)
- First posted
- 15 Sep 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.
Objective: to test the hypothesis that an intervention comprised of targeted physician and print messages can influence parents to reduce the amount of sugar-sweetened beverages (SSB) and fruit juice they give to their children 1 - 12 years of age.
Detailed description
The study will be conducted through a practice-based research network of community pediatric practices. Participating sites will be randomized to the intervention or control condition (usual care) using a pre-specified randomization scheme derived using computer generated random numbers. The intervention sites will participate in a 30-minute training for using the "Milk. Water. Period" intervention (brochures, posters, key talking points and phone messages) in their office. The goal is for them to discuss beverage consumption and encourage "Milk. Water. Period" for all children 12 months to 12 years old (not yet reached their 13th birthday) at their checkup visit. The primary care provider (PCP) will use the talking points to facilitate the discussion about drink milk and water only and will give a brochure to each family. Assessments will be by telephone interview of the parent 2 to 4 weeks after a check-up visit for the index child.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physician communication | Experimental | Behavioral: Physician communicationThe "Milk. Water. Period" intervention comprises brochures, posters, and key talking points for use by primary pediatricians to use in discussion with the parent about the child's beverages consumption. |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parent of child age 12 months to 12 years attending for a check-up visit during the study period
Key exclusion criteria (3 listed)
- Cannot speak English
- No phone access
- Already completed the survey for another child.
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 |
|---|---|---|
| Physician communication | Behavioural | Physician communication |
Primary outcome
Excessive calories from beverages
Time frame: 2-4 weeks after check-up visit
percent of children consuming >200 calories/day from soda, SSBs, and fruit juice beverages
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 2 Oct 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician communication in people with Unhealthy Diet, run by Washington University School of Medicine 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 1 inclusion and 3 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 2 Oct 2018. 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?
Excessive calories from beverages (time frame: 2-4 weeks after check-up visit). 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 2 Oct 2018.