Family Weight Management Study

Obesity Clinical Trial

Official title:

Comprehensive Approach to Family Weight Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00851201
• Other study ID #: R18DK075981
• Status: Completed
• Phase: N/A
• First received: February 23, 2009
• Last updated: October 16, 2017
• Start date: August 2009
• Est. completion date: April 2013

Study information

• Verified date: October 2017
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: April 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	North Bronx Health Network	The Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Albert Einstein College of Medicine, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

Wright ND, Groisman-Perelstein AE, Wylie-Rosett J, Vernon N, Diamantis PM, Isasi CR. A lifestyle assessment and intervention tool for pediatric weight management: the HABITS questionnaire. J Hum Nutr Diet. 2011 Feb;24(1):96-100. doi: 10.1111/j.1365-277X.2010.01126.x. Epub 2010 Sep 30. — View Citation

Wylie-Rosett J, Isasi C, Soroudi N, Soroker E, Sizemore C, Groisman-Perelstein A, Bass J, Diamantis P, Ahmed T, Gandhi R. KidWAVE: Get Healthy Game--promoting a more healthful lifestyle in overweight children. J Nutr Educ Behav. 2010 May-Jun;42(3):210-2. doi: 10.1016/j.jneb.2009.12.003. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI percentile for age and sex, biomarkers e.g, glucose, insulin, lipids		12 months after randomization
Secondary	dietary intake, and physical activity measures		12 months after randomization