ObesityNCT01533896
Can a Brief Primary Care Intervention Affect Healthy Weight Habits
A study testing Grow Nicely in people with Obesity, run by Vanderbilt University at 1 site in United States.
Trial summary
Parents should receive anticipatory guidance about obesity prevention as part of the routine well child visit. Educational resources are needed to help physicians routinely provide these important anticipatory guidance messages. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Grow Nicely
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Oct 2010
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- English and Spanish speaking parents of 2-12 year old children presenting to the pediatric primary care clinic.
Who cannot join
- Parent does not speak English or Spanish.
- Child presenting for an acute care visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Pediatric Primary Care Clinic
Nashville, Tennessee, 37232
About this study
Parents should receive anticipatory guidance about obesity prevention as part of the routine well child visit. Educational resources are needed to help physicians routinely provide these important anticipatory guidance messages. In this study, consecutive parents will be exposed to routine anticipatory guidance messages before the well child visit with the physician. After the clinic visit, parents will be invited to participate in a research study to determine if they plan any changes at home. The key research question of this study is: Can a brief multimedia intervention help parents develop plans to help their children have a healthy weight?
- Conditions
- Obesity
- Being tested
- Grow Nicely
- Keywords
- Obesity prevention, Primary care, Education
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grow NicelyBehavioural
Grow Nicely is a multimedia educational tool, developed at Vanderbilt University that teaches why and how to help children reach and maintain a healthy weight.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Parents and children in the control group received routine primary care during the well child visit. |
| Grow Nicely | Experimental | Grow Nicely multimedia program. Receives: Behavioral: Grow Nicely |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in healthy weight habits
At the time of the follow up phone call 2-4 weeks post-intervention, parents were asked: "Since the clinic visit have you made any changes to help your child either reach or maintain a healthy weight? "
- Yes "If yes, what changes have you made?"
Measured: 2 -4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startJun 2010
- Primary completionOct 2010
- Study completionOct 2010
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.
- 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
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seth Scholer, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533896
- Sponsor's protocol ID
- grownicely
- Status last verified
- Feb 2012
- First submitted
- 10 Feb 2012
- Last updated
- 15 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Brief Primary Care Intervention Affect Healthy Weight Habits
- ClinicalTrials.gov ID
- NCT01533896
- Acronym / sponsor ID
- grownicely
- Conditions
- Obesity
- Keywords
- Obesity prevention, Primary care, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 15 Feb 2012 (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.
Parents should receive anticipatory guidance about obesity prevention as part of the routine well child visit. Educational resources are needed to help physicians routinely provide these important anticipatory guidance messages. In this study, consecutive parents will be exposed to routine anticipatory guidance messages before the well child visit with the physician. After the clinic visit, parents will be invited to participate in a research study to determine if they plan any changes at home. The key research question of this study is: Can a brief multimedia intervention help parents develop plans to help their children have a healthy weight?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Parents and children in the control group received routine primary care during the well child visit. |
| Grow Nicely | Experimental | Behavioral: Grow NicelyGrow Nicely multimedia program. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- English and Spanish speaking parents of 2-12 year old children presenting to the pediatric primary care clinic.
Key exclusion criteria (2 listed)
- Parent does not speak English or Spanish.
- Child presenting for an acute care visit.
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 |
|---|---|---|
| Grow NicelyGrow Nicely is a multimedia educational tool, developed at Vanderbilt University that teaches why and how to help children reach and maintain a healthy weight. | Behavioural | Grow Nicely |
Primary outcome
Changes in healthy weight habits
Time frame: 2 -4 weeks
At the time of the follow up phone call 2-4 weeks post-intervention, parents were asked: "Since the clinic visit have you made any changes to help your child either reach or maintain a healthy weight? " * Yes "If yes, what changes have you made?"
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 15 Feb 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.
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 Grow Nicely in people with Obesity, run by Vanderbilt 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 1 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 15 Feb 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?
Changes in healthy weight habits (time frame: 2 -4 weeks). 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 15 Feb 2012.