View Clinical Trial (Medical Research Study)
Comprehensive Approach to Family Weight Management
| City: |
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Bronx |
| State: |
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New York |
| Zip Code: |
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10461 |
| Conditions: |
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Obesity - Diabetes |
| Purpose: |
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The purpose of this study is to address the Healthy People 2010 obesity prevention
objective. This study will test the effects of a comprehensive family weight management
program on the BMI z-score of 7-12 year-old children with a BMI > 85th percentile who
receive primary care in a large municipal Bronx hospital. The intervention framework will
draw on social marketing theory and the transtheoretical model of behavioral change to
incorporate successful obesity prevention strategies. A two-arm randomized controlled
clinical trial (RCT), which will enroll (n =506) 7-12 year old children with a > 85th BMI
percentile, will compare the Experimental Intensive Intervention to a Standard (Control)
Intervention. The Standard Intervention will receive: 1) an initial consult, which includes
an overview of lifestyle goals, 2)quarterly follow-up, 3) and a monthly newsletter. The
Intensive Intervention will add: 1)12 core group modules for parents (to address roles and
skills) and for children (to enhance motivation and skills and to provide physical
activity), 3) Tailored support using a "toolbox" approach from community health workers as
extensions of the Family Weight Management professional education staff, and 4) monthly
after-core follow-up groups. The study will determine if children randomized to the
Experimental Intensive Intervention will have greater improvement in BMI change (z-scores)
than those randomized to the Control Standard Intervention. The study will also evaluate the
effects on the Experimental Intervention on lifestyle variables and assess intervention
costs. The RE-AIM evaluation will address: Reach: How many of the eligible children/
families were referred and how many of those referred actually enrolled? We will use BMI
data in the computerized medical records to evaluate the proportion and the appropriateness
of the referrals. Efficacy/Effectiveness: How did the Experimental intervention affect BMI
(changes in z-score), and key biomarkers when followed as planned? Adoption: How acceptable
were the intervention(s) to the primary care medical team and the children/families in the
pediatric clinics etc? (from process measures and post intervention surveys) Implementation:
How many of the intervention activities were provided as planned? Quality control measures
will be used to evaluate the integrity of the intervention(s). Maintenance: How much of the
intervention effect is sustainable? Individual effects will be evaluated based on the 24
month follow data. Institutional effects evaluation will include the potential to maintain
services using third-party coverage.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
BMI greater than 85th percentile for sex, age 7-12 years
Exclusion Criteria:
health or condition that would interfere with study participation, unwilling or inability
to provide parent/guardian consent or child ascent, intention to move from area
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| NCT ID: |
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NCT00851201 |
| Primary Contact: |
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Carmen Isasi, MD, PhD
Phone: 718-430-2950
Email: crisasi@aecom.yu.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Bronx, New York 10461
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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