The Healthy Families Project (HF)
Primary Purpose
Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinician enhanced screening and counseling prompts
Tailored education and motivational materials
basic educational brochure
Sponsored by
About this trial
This is an interventional prevention trial for Childhood Obesity focused on measuring Childhood Obesity, Primary Care, Counseling, Screening
Eligibility Criteria
Inclusion Criteria:
- Families with children ages 4 to 11 years
- For post visit supports; Children > 85% for age BMI
Sites / Locations
- Dartmouth Hitchcock Medical Center
- Dartmouth Medical School, Dartmouth Hitchcock Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Parent/child tailored mailed materials
Basic information at single time
Arm Description
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
Family provided with high quality booklet from American Dietetic Association providing the same information that intervention arm received but not tailored.
Outcomes
Primary Outcome Measures
BMI z score
Prevention of increase in BMI
Secondary Outcome Measures
Parental readiness to initiate change
Exit surveys comparing parents with PDA screening vs not for readiness to make changes
Full Information
NCT ID
NCT01193374
First Posted
August 31, 2010
Last Updated
May 23, 2011
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT01193374
Brief Title
The Healthy Families Project
Acronym
HF
Official Title
Promoting Healthy Families Through Enhanced Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Childhood Obesity, Primary Care, Counseling, Screening
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
149 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parent/child tailored mailed materials
Arm Type
Experimental
Arm Description
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
Arm Title
Basic information at single time
Arm Type
Active Comparator
Arm Description
Family provided with high quality booklet from American Dietetic Association providing the same information that intervention arm received but not tailored.
Intervention Type
Behavioral
Intervention Name(s)
Clinician enhanced screening and counseling prompts
Other Intervention Name(s)
All subjects receive screening/counseling
Intervention Description
PDA based health risk screening for well child issues and obesity risks
Intervention Type
Behavioral
Intervention Name(s)
Tailored education and motivational materials
Other Intervention Name(s)
Well child care intervention
Intervention Description
Specific tailoring for those interested in change vs not . Two newsletters over 3 mpn.
Intervention Type
Behavioral
Intervention Name(s)
basic educational brochure
Other Intervention Name(s)
Education
Intervention Description
Booklet by ADA sent x 1.
Primary Outcome Measure Information:
Title
BMI z score
Description
Prevention of increase in BMI
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Parental readiness to initiate change
Description
Exit surveys comparing parents with PDA screening vs not for readiness to make changes
Time Frame
immediately post well visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Families with children ages 4 to 11 years
For post visit supports; Children > 85% for age BMI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ardis L Olson, MD
Organizational Affiliation
Dartmouth Medical School, Dept. of Pediatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0001
Country
United States
Facility Name
Dartmouth Medical School, Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0001
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Healthy Families Project
We'll reach out to this number within 24 hrs