The Healthy Families Project

Childhood Obesity Clinical Trial

— HF  

Official title:

Promoting Healthy Families Through Enhanced Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01193374
• Other study ID #: R21HD050996
• Status: Completed
• Phase: N/A
• First received: August 31, 2010
• Last updated: May 23, 2011
• Start date: February 2007
• Est. completion date: August 2009

Study information

• Verified date: May 2011
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: August 2009
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 10 Years

Eligibility

Inclusion Criteria:

• Families with children ages 4 to 11 years

• For post visit supports; Children > 85% for age BMI

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Clinician enhanced screening and counseling prompts
PDA based health risk screening for well child issues and obesity risks
• Tailored education and motivational materials
Specific tailoring for those interested in change vs not . Two newsletters over 3 mpn.
• basic educational brochure
Booklet by ADA sent x 1.

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Dartmouth Medical School, Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI z score	Prevention of increase in BMI	6 months	No
Secondary	Parental readiness to initiate change	Exit surveys comparing parents with PDA screening vs not for readiness to make changes	immediately post well visit	No