ObesityNCT00944164
Primary Care Obesity Prevention and Treatment
A study testing Healthy eating and physical activity and Safety and injury prevention in people with Obesity, run by University of Washington at 2 sites in United States.
Trial summary
The overall objective of this pilot is to demonstrate the feasibility of a low-cost intervention targeting obesity prevention among children in a primary care setting. Specifically, the investigators aim to answer the following questions: Can the investigators recruit and retain patients using the methods proposed… Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Obesity
- What is being tested?
- Healthy eating and physical activity and Safety and injury prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2006to Aug 2008
- 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 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child BMI ≥ 70th percentile for age and sex according to CDC Growth Tables
- child scheduled for an upcoming well child visit
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Health Partners Research Foundation
Minneapolis, Minnesota, 55440
University of Washington
Seattle, Washington, 98105
About this study
Official title: Test the Feasibility of Primary Care Obesity Prevention and Treatment - Pilot Study
The overall objective of this pilot is to demonstrate the feasibility of a low-cost intervention targeting obesity prevention among children in a primary care setting.
Specifically, the investigators aim to answer the following questions:
Can the investigators recruit and retain patients using the methods proposed, and how easy or difficult will this process be?
Can physicians deliver the proposed intervention messages in the time the investigators have proposed?
Can the phone counselor reach participants and accomplish the goals outlined for these calls?
Can the investigators obtain the data proposed and within the proposed time frame?
- Conditions
- Obesity
- Being tested
- Healthy eating and physical activity, Safety and injury prevention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy eating and physical activityBehavioural
Parent counseling and coaching regarding healthy eating and physical activity habits for their child
Safety and injury preventionBehavioural
Parent counseling and coaching regarding general personal and household safety
| Study group | Role | What they receive |
|---|---|---|
| Healthy eating/physical activity | Experimental | Not described Receives: Behavioral: Healthy eating and physical activity |
| Safety/Injury prevention | Active comparator | Not described Receives: Behavioral: Safety and injury prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruiting and retaining families
Measured: Enrollment to 3-month followup
Secondary outcomes (3)
Child weight (BMI)
Measured: Baseline and 3-months post
Parental perceptions of child weight
Measured: Baseline and 3-months post intervention
Satisfaction with intervention
Measured: 3-months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startSep 2006
- Primary completionAug 2008
- Study completionAug 2008
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 WashingtonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Group Health, Fred Hutchinson Cancer Center
- Investigators
- Rona L Levy, MSW, PhD, MPH, Principal investigator, University of WashingtonNancy Sherwood, PhD, Principal investigator, Health Partners Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944164
- Sponsor's protocol ID
- HS-06-C40
- Status last verified
- Jul 2009
- First submitted
- 9 Jul 2009
- Last updated
- 23 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test the Feasibility of Primary Care Obesity Prevention and Treatment - Pilot Study
- ClinicalTrials.gov ID
- NCT00944164
- Acronym / sponsor ID
- HS-06-C40
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Group Health, Fred Hutchinson Cancer Center
- Study start
- Sep 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 23 Jul 2009 (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.
The overall objective of this pilot is to demonstrate the feasibility of a low-cost intervention targeting obesity prevention among children in a primary care setting.
Specifically, the investigators aim to answer the following questions:
Can the investigators recruit and retain patients using the methods proposed, and how easy or difficult will this process be?
Can physicians deliver the proposed intervention messages in the time the investigators have proposed?
Can the phone counselor reach participants and accomplish the goals outlined for these calls?
Can the investigators obtain the data proposed and within the proposed time frame?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy eating/physical activity | Experimental | Behavioral: Healthy eating and physical activity |
| Safety/Injury prevention | Active comparator | Behavioral: Safety and injury prevention |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- child BMI ≥ 70th percentile for age and sex according to CDC Growth Tables
- child scheduled for an upcoming well child visit
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Healthy eating and physical activityParent counseling and coaching regarding healthy eating and physical activity habits for their child | Behavioural | Healthy eating/physical activity |
| Safety and injury preventionParent counseling and coaching regarding general personal and household safety | Behavioural | Safety/Injury prevention |
Primary outcome
Feasibility of recruiting and retaining families
Time frame: Enrollment to 3-month followup
3 secondary outcomes
Child weight (BMI)
Time frame: Baseline and 3-months post
Parental perceptions of child weight
Time frame: Baseline and 3-months post intervention
Satisfaction with intervention
Time frame: 3-months post intervention
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 23 Jul 2009.
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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.
Rona L Levy, MSW, PhD, MPH principal investigator
University of Washington
Nancy Sherwood, PhD principal investigator
Health Partners Research Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy eating and physical activity and Safety and injury prevention in people with Obesity, run by University of Washington at 2 sites 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 2 inclusion and 0 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 23 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Feasibility of recruiting and retaining families (time frame: Enrollment to 3-month followup). 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 23 Jul 2009.