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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00851201 |
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.
Condition | Intervention |
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Obesity Diabetes |
Behavioral: lifestyle intervention |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | Comprehensive Approach to Family Weight Management |
Estimated Enrollment: | 506 |
Study Start Date: | August 2009 |
Estimated Study Completion Date: | April 2013 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1-Standard 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.
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Behavioral: lifestyle intervention
Study will compare a minimal intervention control (standard intervention) to a comprehensive lifestyle intervention.
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Intensive lifestyle: Experimental
The intervention will include 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.
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Behavioral: lifestyle intervention
Study will compare a minimal intervention control (standard intervention) to a comprehensive lifestyle intervention.
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Ages Eligible for Study: | 7 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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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Contact: Carmen Isasi, MD, PhD | 718-430-2950 | crisasi@aecom.yu.edu |
United States, New York | |
North Bronx Health Network | |
Bronx, New York, United States, 10461 |
Responsible Party: | Albert Einstein College of Medicine ( Judith Wylie-Rosett ) |
Study ID Numbers: | 1R18DK075981 |
Study First Received: | February 23, 2009 |
Last Updated: | August 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00851201 History of Changes |
Health Authority: | United States: Federal Government |
children obesity weight loss |
prevention diabetes risk cardiometabolic |
Body Weight Signs and Symptoms Obesity Weight Loss |
Diabetes Mellitus Nutrition Disorders Overweight Overnutrition |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |