NCT01533896

Brief 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. 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?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
221

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jun 2010

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
Last Updated

February 15, 2012

Status Verified

February 1, 2012

Enrollment Period

4 months

First QC Date

February 10, 2012

Last Update Submit

February 14, 2012

Conditions

Keywords

Obesity preventionPrimary careEducation

Outcome Measures

Primary Outcomes (1)

  • 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?"

    2 -4 weeks

Study Arms (2)

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.

Behavioral: Grow Nicely

Interventions

Grow NicelyBEHAVIORAL

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.

Grow Nicely

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • English and Spanish speaking parents of 2-12 year old children presenting to the pediatric primary care clinic.

You may not qualify if:

  • Parent does not speak English or Spanish.
  • Child presenting for an acute care visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Pediatric Primary Care Clinic

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

February 10, 2012

First Posted

February 15, 2012

Study Start

June 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

February 15, 2012

Record last verified: 2012-02

Locations