NCT00944164

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2009

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 23, 2009

Completed
Last Updated

July 23, 2009

Status Verified

July 1, 2009

Enrollment Period

1.9 years

First QC Date

July 9, 2009

Last Update Submit

July 21, 2009

Conditions

Outcome Measures

Primary Outcomes (1)

  • Feasibility of recruiting and retaining families

    Enrollment to 3-month followup

Secondary Outcomes (3)

  • Child weight (BMI)

    Baseline and 3-months post

  • Parental perceptions of child weight

    Baseline and 3-months post intervention

  • Satisfaction with intervention

    3-months post intervention

Study Arms (2)

Healthy eating/physical activity

EXPERIMENTAL
Behavioral: Healthy eating and physical activity

Safety/Injury prevention

ACTIVE COMPARATOR
Behavioral: Safety and injury prevention

Interventions

Parent counseling and coaching regarding healthy eating and physical activity habits for their child

Healthy eating/physical activity

Parent counseling and coaching regarding general personal and household safety

Safety/Injury prevention

Eligibility Criteria

Age5 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Health Partners Research Foundation

Minneapolis, Minnesota, 55440, United States

Location

University of Washington

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Diet, HealthyExerciseSafety

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaAccident PreventionAccidentsPublic HealthEnvironment and Public Health

Study Officials

  • Rona L Levy, MSW, PhD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR
  • Nancy Sherwood, PhD

    Health Partners Research Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 9, 2009

First Posted

July 23, 2009

Study Start

September 1, 2006

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

July 23, 2009

Record last verified: 2009-07

Locations