The Healthy Families Project
HF
Promoting Healthy Families Through Enhanced Primary Care
1 other identifier
interventional
149
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2007
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 31, 2010
CompletedFirst Posted
Study publicly available on registry
September 1, 2010
CompletedMay 24, 2011
May 1, 2011
1.1 years
August 31, 2010
May 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
BMI z score
Prevention of increase in BMI
6 months
Secondary Outcomes (1)
Parental readiness to initiate change
immediately post well visit
Study Arms (2)
Parent/child tailored mailed materials
EXPERIMENTALFamily provided newsletters tailored to issues and readiness to change. Family receives educational nutrition DVD, pedometers for family activities and child nutrition/physical activity games
Basic information at single time
ACTIVE COMPARATORFamily provided with high quality booklet from American Dietetic Association providing the same information that intervention arm received but not tailored.
Interventions
PDA based health risk screening for well child issues and obesity risks
Specific tailoring for those interested in change vs not . Two newsletters over 3 mpn.
Booklet by ADA sent x 1.
Eligibility Criteria
You may qualify if:
- Families with children ages 4 to 11 years
- For post visit supports; Children \> 85% for age BMI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001, United States
Dartmouth Medical School, Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ardis L Olson, MD
Dartmouth Medical School, Dept. of Pediatrics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
August 31, 2010
First Posted
September 1, 2010
Study Start
February 1, 2007
Primary Completion
March 1, 2008
Study Completion
August 1, 2009
Last Updated
May 24, 2011
Record last verified: 2011-05