The Healthy Families Project (HF)

Promoting Healthy Families Through Enhanced Primary Care

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.

Study Overview

• Status: Completed
• Conditions: Childhood Obesity
• Intervention / Treatment: Behavioral: Clinician enhanced screening and counseling prompts; Behavioral: Tailored education and motivational materials; Behavioral: basic educational brochure

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.

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756-0001
      • Dartmouth Hitchcock Medical Center
    • Lebanon, New Hampshire, United States, 03756-0001
      • Dartmouth Medical School, Dartmouth Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: Clinician enhanced screening and counseling prompts; PDA based health risk screening for well child issues and obesity risks; Other Names: All subjects receive screening/counseling; Behavioral: Tailored education and motivational materials; Specific tailoring for those interested in change vs not . Two newsletters over 3 mpn.; Other Names: Well child care intervention
Active Comparator: 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.	Behavioral: Clinician enhanced screening and counseling prompts; PDA based health risk screening for well child issues and obesity risks; Other Names: All subjects receive screening/counseling; Behavioral: basic educational brochure; Booklet by ADA sent x 1.; Other Names: Education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI z score	Prevention of increase in BMI	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental readiness to initiate change	Exit surveys comparing parents with PDA screening vs not for readiness to make changes	immediately post well visit

Collaborators and Investigators

• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Ardis L Olson, MD, Dartmouth Medical School, Dept. of Pediatrics

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: August 31, 2010
• First Submitted That Met QC Criteria: August 31, 2010
• First Posted (Estimate): September 1, 2010

Study Record Updates

• Last Update Posted (Estimate): May 24, 2011
• Last Update Submitted That Met QC Criteria: May 23, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: Counseling; Primary Care; Childhood Obesity; Screening
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: R21HD050996 (U.S. NIH Grant/Contract)