The Healthy Families Project

NCT ID: NCT01193374

Last Updated: 2011-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-08-31

Brief Summary

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A primary care approach to obesity prevention will be developed and tested in a randomized trial in 4 pediatric primary care practices. Enhanced screening for obesity risks and prompts for effective counseling at well visits of 4 to 10 year olds will be developed utilizing hand held technology( PDAs). The impact on the content and quality of clinician counseling will be assessed in exit survey prior to and after implementation. Among families interested in making a change to address nutrition or activity risk reported on the screener a cohort with children \> BMI 85% will be recruited. They will be randomized to mailed tailored supports to level of readiness to change versus a single generic informational mailing. The hypotheses are that 1)families that receive the enhanced office visit with screening will be more likely to plan to make changes compared to usual care; and 2) families receiving the tailored post visit supports will be less likely to gain weight than controls after 6 months.

Detailed Description

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1. Using hand held PDAs, we will develop an obesity risk screening and counseling system for 4 through 10 year olds attending primary care well child visits. Screening results will be summarized immediately by the PDA and will prompt the clinician to provide brief counseling messages tailored to each childís obesity screening results, including the familyís and the childís readiness to change behavior
2. We will evaluate the specific content and quality of clinician obesity counseling provided at the well child visit through parent surveys before and after implementation of the PDA screening and counseling program.
3. To support action by families after the office visit, we will develop a post-visit intervention package of newsletters and materials that are tailored to child/family obesity risk behaviors and parental readiness to change.
4. We will evaluate the impact of this post visit intervention program in a 6 month trial focused on children identified at well child screening to have BMI \>85%. 200 Families will be randomized to receive either a series of mailed supports over 3 months versus a single generic-content mailing. We will determine the respective impact of these two levels of post-visit support on stage of change, parental action on key obesity risk behaviors, and stabilization of BMI z scores after 6 months.

Conditions

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Childhood Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Parent/child tailored mailed materials

Family provided newsletters tailored to issues and readiness to change. Family receives educational nutrition DVD, pedometers for family activities and child nutrition/physical activity games

Group Type EXPERIMENTAL

Clinician enhanced screening and counseling prompts

Intervention Type BEHAVIORAL

PDA based health risk screening for well child issues and obesity risks

Tailored education and motivational materials

Intervention Type BEHAVIORAL

Specific tailoring for those interested in change vs not . Two newsletters over 3 mpn.

Basic information at single time

Family provided with high quality booklet from American Dietetic Association providing the same information that intervention arm received but not tailored.

Group Type ACTIVE_COMPARATOR

Clinician enhanced screening and counseling prompts

Intervention Type BEHAVIORAL

PDA based health risk screening for well child issues and obesity risks

basic educational brochure

Intervention Type BEHAVIORAL

Booklet by ADA sent x 1.

Interventions

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Clinician enhanced screening and counseling prompts

PDA based health risk screening for well child issues and obesity risks

Intervention Type BEHAVIORAL

Tailored education and motivational materials

Specific tailoring for those interested in change vs not . Two newsletters over 3 mpn.

Intervention Type BEHAVIORAL

basic educational brochure

Booklet by ADA sent x 1.

Intervention Type BEHAVIORAL

Other Intervention Names

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All subjects receive screening/counseling Well child care intervention Education

Eligibility Criteria

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Inclusion Criteria

* Families with children ages 4 to 11 years
* For post visit supports; Children \> 85% for age BMI
Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role lead

Responsible Party

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Dartmouth College

Principal Investigators

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Ardis L Olson, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth Medical School, Dept. of Pediatrics

Locations

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Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Dartmouth Medical School, Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

Other Identifiers

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R21HD050996

Identifier Type: NIH

Identifier Source: org_study_id

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