Family Weight Management Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00851201
First received: February 23, 2009
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

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
Obesity
Diabetes
Behavioral: lifestyle intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comprehensive Approach to Family Weight Management

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • BMI percentile for age and sex, biomarkers e.g, glucose, insulin, lipids [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • dietary intake, and physical activity measures [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]

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
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.
Behavioral: lifestyle intervention
Study will compare a minimal intervention control (standard intervention) to a comprehensive lifestyle intervention.
Experimental: Intensive lifestyle
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.
Behavioral: lifestyle intervention
Study will compare a minimal intervention control (standard intervention) to a comprehensive lifestyle intervention.

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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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  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: NCT00851201

Contacts
Contact: Carmen Isasi, MD, PhD 718-430-2950 crisasi@aecom.yu.edu

Locations
United States, New York
North Bronx Health Network Recruiting
Bronx, New York, United States, 10461
Sub-Investigator: Adriana Groisman, MD         
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: Judith Wylie-Rosett, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT00851201     History of Changes
Other Study ID Numbers: R18 DK075981
Study First Received: February 23, 2009
Last Updated: October 16, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
children
obesity
weight loss
prevention
diabetes risk
cardiometabolic

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014