The Healthy Families Project (HF)

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01193374
First received: August 31, 2010
Last updated: May 23, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Childhood Obesity
Behavioral: Clinician enhanced screening and counseling prompts
Behavioral: Tailored education and motivational materials
Behavioral: basic educational brochure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Promoting Healthy Families Through Enhanced Primary Care

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • BMI z score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Prevention of increase in BMI


Secondary Outcome Measures:
  • Parental readiness to initiate change [ Time Frame: immediately post well visit ] [ Designated as safety issue: No ]
    Exit surveys comparing parents with PDA screening vs not for readiness to make changes


Enrollment: 149
Study Start Date: February 2007
Study Completion Date: August 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: All subjects receive screening/counseling
Behavioral: basic educational brochure
Booklet by ADA sent x 1.
Other Name: Education

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.
  Eligibility

Ages Eligible for Study:   4 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Families with children ages 4 to 11 years
  • For post visit supports; Children > 85% for age BMI
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01193374

Locations
United States, New Hampshire
Dartmouth Medical School, Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0001
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0001
Sponsors and Collaborators
Investigators
Principal Investigator: Ardis L Olson, MD Dartmouth Medical School, Dept. of Pediatrics
  More Information

No publications provided

Responsible Party: Ardis L. Olson, Dartmouth College
ClinicalTrials.gov Identifier: NCT01193374     History of Changes
Other Study ID Numbers: R21HD050996
Study First Received: August 31, 2010
Last Updated: May 23, 2011
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Childhood Obesity
Primary Care
Counseling
Screening

Additional relevant MeSH terms:
Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014