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Family Weight Management Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00851201
First Posted: February 25, 2009
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Albert Einstein College of Medicine, Inc.
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
February 23, 2009
February 25, 2009
October 18, 2017
August 2009
December 2012   (Final data collection date for primary outcome measure)
BMI percentile for age and sex, biomarkers e.g, glucose, insulin, lipids [ Time Frame: 12 months after randomization ]
Same as current
Complete list of historical versions of study NCT00851201 on ClinicalTrials.gov Archive Site
dietary intake, and physical activity measures [ Time Frame: 12 months after randomization ]
Same as current
Not Provided
Not Provided
 
Family Weight Management Study
Comprehensive Approach to Family Weight Management
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Obesity
  • Diabetes
  • Behavioral: Intensive lifestyle
    The intensive lifestyle intervention will include the standard intervention plus 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.
  • Behavioral: 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.
  • Active Comparator: Standard Intervention
    Intervention: Behavioral: Standard intervention
  • Experimental: Intensive lifestyle
    Intervention: Behavioral: Intensive lifestyle

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
April 2013
December 2012   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
7 Years to 12 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00851201
R18DK075981( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Albert Einstein College of Medicine, Inc.
Principal Investigator: Judith Wylie-Rosett, EdD, RD Albert Einstein College of Medicine, Inc.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP