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The Healthy Families Project

Promoting Healthy Families Through Enhanced Primary Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01193374
Acronym
HF
Enrollment
149
Registered
2010-09-01
Start date
2007-02-28
Completion date
2009-08-31
Last updated
2011-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity

Keywords

Childhood Obesity, Primary Care, Counseling, Screening

Brief summary

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

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.

Interventions

BEHAVIORALClinician enhanced screening and counseling prompts

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

BEHAVIORALTailored education and motivational materials

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

BEHAVIORALbasic educational brochure

Booklet by ADA sent x 1.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
BMI z score6 monthsPrevention of increase in BMI

Secondary

MeasureTime frameDescription
Parental readiness to initiate changeimmediately post well visitExit surveys comparing parents with PDA screening vs not for readiness to make changes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026