Primary Care Obesity Prevention and Treatment | NCT00944164

Studies
Primary Care Obesity Prevention and Treatment

NCT00944164

Sponsor

University of Washington

Status

Completed

Last Update Posted

Jul 23, 2009Estimated

Enrollment

176Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

Healthy eating and physical activity
Safety and injury prevention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Jul 9, 2009

First Submission Date that Met QC Criteria

Jul 21, 2009

First Posted Date

Jul 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2009

Last Update Posted Date

Jul 23, 2009Estimated

Name	Class
Group Health	UNKNOWN
Fred Hutchinson Cancer Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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, 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?

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

176Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy eating/physical activity	Experimental		Behavioral: Healthy eating and physical activity
Safety/Injury prevention	Active Comparator		Behavioral: Safety and injury prevention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Healthy eating and physical activity	Behavioral	Parent counseling and coaching regarding healthy eating and physical activity habits for their child	Healthy eating/physical activity

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility of recruiting and retaining families		Enrollment to 3-month followup

Secondary Outcomes

Measure	Description	Time Frame
Child weight (BMI)		Baseline and 3-months post
Parental perceptions of child weight		Baseline and 3-months post intervention
Satisfaction with intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

child BMI ≥ 70th percentile for age and sex according to CDC Growth Tables
child scheduled for an upcoming well child visit

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

9 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rona L Levy, MSW, PhD, MPH	University of Washington	Principal Investigator
Nancy Sherwood, PhD	Health Partners Research Foundation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Health Partners Research Foundation		Minneapolis	Minnesota	55440	United States
University of Washington

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000072001	Diet, Healthy
D015444	Exercise
D012449	Safety

Ancestor Terms

ID	Term
D004032	Diet
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided